U.S. patent application number 16/113133 was filed with the patent office on 2018-12-20 for needle-less injector and method of fluid delivery.
The applicant listed for this patent is PharmaJet, Inc.. Invention is credited to John Bingham, Robert Steinway.
Application Number | 20180361070 16/113133 |
Document ID | / |
Family ID | 39149747 |
Filed Date | 2018-12-20 |
United States Patent
Application |
20180361070 |
Kind Code |
A1 |
Bingham; John ; et
al. |
December 20, 2018 |
NEEDLE-LESS INJECTOR AND METHOD OF FLUID DELIVERY
Abstract
A method and system of manufacturing a needle-less injector to
deliver an injection having a pre-determined injection dosage. The
method and system include providing an injector housing, installing
a compressible coiled delivery spring within the housing, and
selecting a hammer having a length from a plurality of alternative
hammers having different lengths, wherein the length of the
selected hammer corresponds to the pre-determined injection dosage.
The method further includes installing the selected hammer within
the housing in contact with the compressible coiled delivery spring
and further in contact with a syringe plunger such that upon
assembly of the needle-less injector, decompression of the
compressible coiled delivery spring causes the selected hammer to
move laterally, thereby causing the syringe plunger to move
laterally within a needle-less syringe to provide an injection
having the pre-determined injection dosage corresponding to the
length of the selected hammer.
Inventors: |
Bingham; John; (Elizabeth,
CO) ; Steinway; Robert; (Boulder, CO) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
PharmaJet, Inc. |
Golden |
CO |
US |
|
|
Family ID: |
39149747 |
Appl. No.: |
16/113133 |
Filed: |
August 27, 2018 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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15139981 |
Apr 27, 2016 |
10099011 |
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16113133 |
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14019202 |
Sep 5, 2013 |
9333300 |
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15139981 |
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13162302 |
Jun 16, 2011 |
8529500 |
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14019202 |
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12575394 |
Oct 7, 2009 |
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13162302 |
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11598193 |
Nov 13, 2006 |
7618393 |
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12575394 |
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11121439 |
May 3, 2005 |
7699802 |
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11598193 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/002 20130101;
A61M 2205/6081 20130101; A61M 5/425 20130101; A61M 5/30 20130101;
A61M 5/3158 20130101; A61M 2005/208 20130101 |
International
Class: |
A61M 5/30 20060101
A61M005/30; A61M 5/315 20060101 A61M005/315 |
Claims
1. A method of manufacturing a needle-less injector to deliver an
injection having a pre-determined injection dosage, said method
comprising: providing an injector housing; installing a
compressible coiled delivery spring within the housing; selecting a
hammer having a length from a plurality of alternative hammers
having different lengths, wherein the length of the selected hammer
corresponds to the pre-determined injection dosage; installing the
selected hammer within the housing in contact with the compressible
coiled delivery spring and further in contact with a syringe
plunger, such that decompression of the compressible coiled
delivery spring causes the selected hammer to move laterally,
thereby causing the syringe plunger to move laterally within a
needle-less syringe to provide an injection having the
pre-determined injection dosage corresponding to the length of the
selected hammer.
2. The method of claim 1, wherein the pre-determined injection
dosage can be varied from 0.1 cc to 1 cc by installing a hammer
having a length corresponding to the pre-determined injection
dosage, without varying a size of the needle-less syringe or
plunger.
3. The method of claim 1 further comprising co-forming the selected
hammer and plunger as a single piece.
4. The method of claim 1 further comprising forming the selected
hammer and plunger as separate pieces.
5. The method of claim 1 further comprising: providing a plurality
of alternative compressible coiled delivery springs having
different spring weights; and selecting one compressible coiled
delivery spring from the plurality of compressible coiled delivery
springs and installing the selected compressible coiled delivery
spring within the housing.
6. The method of claim 5 further comprising selecting the one
compressible coiled delivery spring to configure the needle-less
injector to cause an injection into an intradermal layer.
7. The method of claim 5 further comprising selecting the one
compressible coiled delivery spring to configure the needle-less
injector to cause an injection into an intramuscular layer.
8. The method of claim 5 further comprising selecting the one
compressible coiled delivery spring to configure the needle-less
injector to provide an injection to an adult.
9. The method of claim 5 further comprising selecting the one
compressible coiled delivery spring to configure the needle-less
injector to provide an injection to a child.
10. The method of claim 5 further comprising: selecting the one
compressible coiled delivery spring to manufacture the needle-less
injector to provide an injection to a patient having a first skin
thickness; and selecting a second compressible coiled delivery
spring to manufacture a second needle-less injector to provide an
injection to a patient having a second skin thickness, which is
less than the first skin thickness.
11. The method of claim 5 further comprising providing a storage
case for the needle-less injector that includes a surface that is
color coded to inform a user of the spring weight of the one
compressible coiled delivery spring.
12. A system for manufacturing a needle-less injector to deliver an
injection having a pre-determined dosage, said system comprising:
an injector housing; a compressible coiled delivery spring
installed within the housing; a plurality of alternative hammers
having different lengths, wherein each different hammer length
corresponds to a different injection dosage, such that a hammer
having a selected length installed within the housing in contact
with the compressible coiled delivery spring and further in contact
with a syringe plunger will, upon decompression of the compressible
coiled delivery spring, provide the injection through a needle-less
syringe, said injection having the pre-determined dosage
corresponding to the length of the selected hammer.
13. The system of claim 12, wherein the pre-determined dosage
deliverable by the assembled needle-less injector can be selected
to be within the range of 0.1 cc to 1 cc solely by installing a
hammer having a length corresponding to the pre-determined
dosage.
14. The system of claim 12 wherein the selected hammer and plunger
are co-formed as a single piece.
15. The system of claim 12 wherein the selected hammer and plunger
are formed as separate pieces.
16. The system of claim 12 further comprising a plurality of
alternative compressible coiled delivery springs having different
spring weights, wherein one compressible coiled delivery spring is
selected from the plurality of compressible coiled delivery
springs.
17. The system of claim 16 wherein the plurality of alternative
compressible coiled delivery springs having different spring
weights comprises at least one compressible coiled delivery spring
to cause an injection into an intradermal layer and at least one
other compressible coiled delivery spring to cause an injection in
to an intramuscular tissue layer.
18. The system of claim 16 wherein the plurality of alternative
compressible coiled delivery springs having different spring
weights includes at least one compressible coiled delivery spring
to provide an injection to an adult and at least one other
compressible coiled delivery spring to cause an injection to a
child.
19. The system of claim 16 wherein the plurality of alternative
compressible coiled delivery springs having different spring
weights includes at least one compressible coiled delivery spring
to cause an injection into a patient having a first skin thickness
and at least one other compressible coiled delivery spring to cause
an injection into a patient having a second skin thickness, which
is less than the first skin thickness.
20. The system of claim 16 further comprising a storage case for
the assembled needle-less injector having a surface that is color
coded to indicate to a user the spring weight of the compressible
coiled delivery spring installed in the assembled needle-less
injector.
Description
RELATED APPLICATIONS
[0001] The present application is a continuation of pending U.S.
patent application Ser. No. 15/139,981 entitled "Needle-Less
Injector and Method of Fluid Delivery," filed on Apr. 27, 2016,
which is a continuation of Ser. No. 14/019,202 (now U.S. Pat. No.
9,333,300), entitled "Needle-Less Injector and Method of Fluid
Delivery," filed on Sep. 5, 2013, which is a continuation of U.S.
patent application Ser. No. 13/162,302 (now U.S. Pat. No.
8,529,500), entitled "Needle-less Injector and Method of Fluid
Delivery," filed on Jun. 16, 2011, which is a continuation of U.S.
patent application Serial No. continuation of Ser. No. 12/575,394,
entitled "Needle-Less Injector and Method of Fluid Delivery," filed
on Oct. 7, 2009, which is a continuation of U.S. patent application
Ser. No. 11/598,193 (now U.S. Pat. No. 7,618,393), entitled
"Needle-less Injector and Method of Fluid Delivery," filed on Nov.
13, 2006, which is a continuation-in-part of U.S. patent
application Ser. No. 11/121,439 (now U.S. Pat. No. 7,699,802),
entitled "Needle-less Injector," filed May 3, 2005 and which is
related to U.S. patent application Ser. No. 11/185,736, entitled
"Needless Injector and Ampule System," filed Jul. 21, 2005 and U.S.
patent application Ser. No. 11/453,248, entitled "Vial System and
Method for a Needle-less Injector," filed Jun. 15, 2006, each of
which is hereby incorporated by reference in its entirety.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates to a needle-less injector that
can deliver a high-pressure jet of fluid, such as a medicament,
intramuscularly, intradermally and/or subcutaneously into the
tissue a human or animal, and more particularly to a method of
delivering a specific dose of medicament via a needle-less
injector.
2. Description of Related Art
[0003] The advantages of needle-less injection devices have been
recognized for some time. Some of these advantages include: the
absence of needle stick injuries that present hazards to healthcare
workers; a reduction in the risk of cross-contamination among
patients, whether, human or animal; the elimination of needle
breakage in the tissue of the human or animal; and that the jet of
liquid medicament is generally smaller than the diameter of a
hypodermic needle and thus may be less invasive than a hypodermic
needle.
[0004] Because of the well-known advantages of needle-less
injection, there are many different kinds of such devices,
including pneumatic needle-less injection devices that are designed
to provide multiple doses to patients or animals, or gas actuated,
which are for single or multiple use. Most known needle-less
injection devices operate by using a piston to drive the fluid to
be delivered though a fine nozzle that creates a small, high
pressure stream that penetrates the skin simply due to the high
pressure. Multi-dose and single-dose devices depend on a source of
energy to drive air or working fluid that is used to operate the
piston that drives the fluid through the nozzle. Thus, a serious
limitation of these devices is that they must have a readily
available source of energy to drive the piston. This makes these
devices impractical for use in hospitals and/or clinics, and in
most field situations, especially in remote areas where access to
dependable energy is uncertain.
[0005] These injector devices are also large, sometimes expensive
units, and generally adapted to retain large quantities of
medicament for repeated injections. Most of these machines are not
portable and have historically been used chiefly for mass
inoculation programs.
[0006] Because of the disadvantages of injection devices that use
high-pressure fluids to drive the piston and deliver multiple
injections, a great deal of attention has been given to the
development of a spring-powered needle-less injection device for
delivering a single injection. The success of the known devices has
been limited, due to problems associated with safety and
reliability. The issues regarding safety generally involve the
possibility of accidental discharge of the device and the
possibility of transmitting diseases between patients due to
carryover of body fluids. The problems associated with reliability
generally involve the device's ability to deliver a full, known
dose of the liquid.
[0007] Safety issues generally arise in association with devices
that have exposed triggers or include a hammer or piston driving
device that can extend beyond the inner housing of the injector.
The risk of using this type of device is similar to the risks
associated with the triggers on firearms, and that is the
inadvertent pressing of the trigger, can result in the accidental
or premature firing of the device.
[0008] Reliability issues include a broad spectrum of problems. One
significant problem is the creation of a suitable jet or stream of
fluid and the introduction of this jet on to the skin of the animal
or human. Preferably, the jet will be a very fine jet that will
impact a section of taut skin at an angle of incidence of
preferably 90 degrees. Most of the energy of the stream is used to
penetrate the skin when the jet impacts at approximately 90 degrees
to the skin. Additionally, by keeping the skin taut prior to
delivering the jet of fluid, the skin is not allowed to flex, and
thus more of the energy from the jet is used to penetrate the skin
rather than deflecting or moving the skin.
[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. As disclosed
in U.S. Pat. No. 6,942,638, the entirety of which is hereby
incorporated by reference, a loss of pressure can affect the amount
of medicament delivered.
[0010] There are also disadvantages related to the containment of
the fluid formulations in single dose needle-less injectors.
Individual doses of a liquid formulation can be delivered via the
injector. However, often the volume of medicament held in the
conventional injectors is too large, for example, when injecting an
infant or small animal, such as a mouse. Often one-half or more of
the dosage is not required and hence would be wasted or the
injection could not be given safely to such patient. This decreases
the practicality and use of the injectors in certain
environments.
[0011] Another problem with medicament containment is that many
materials proposed for the vials are unsuitable for long-term
contact with the medicament, or at least would require extensive
and costly validation for each application.
[0012] Another disadvantage of known needle-less injectors is the
inability to direct the location of the injection, i.e.,
intramuscularly, intradermally and/or subcutaneously
SUMMARY OF THE INVENTION
[0013] According to one aspect of the present invention there is
provided a hand-held, spring-powered, needle-less injector device
that can deliver a single dose of liquid, such as a medicament,
both safely and reliably without an external power source.
[0014] In another aspect, the needle-less injector of the present
invent prevents accidental discharge. The needle-less injector
device has a trigger stop that prevents operation of the trigger
when the inner housing in not in the firing position. An example of
this trigger stop includes a protrusion that extends from the outer
housing and impedes the movement of the trigger when inner housing
is not in the firing position. The protrusion then moves away from
the trigger when the inner housing is moved into the firing
position.
[0015] In yet another aspect, the needle-less injector device of
the present invention uses a single-use, disposable needle free
syringe containing a liquid for delivery. The syringe includes a
connector at one end and a nozzle and skin tensioner at the other
end. The connector can be a bayonet type connector. The skin
tensioner can be a ridge that surrounds the nozzle. The syringe is
easily insertable into the injector and provides for a safer
healthcare environment.
[0016] It is still another aspect of the present invention to
provide a needless injector that can deliver smaller doses of
medicament without providing different vial sizes.
[0017] Another aspect of the present invention is to provide a
needless injector that can control the particular location of the
injection, i.e., intramuscularly, intradermally and/or
subcutaneously.
[0018] During operation of the injector, the user will position the
hammer at the cocked position and insert the syringe into the
leading end of the inner housing. The syringe can be pre-filled
with the liquid that is to be delivered to the animal or human as
described above. The user presses the nozzle and skin tensioner
against the animal or human, causing the inner housing of the
device to move against the skin tensioning spring, into or relative
to the outer housing to the firing position. Once the inner housing
is moved to the firing position, the pressure of the skin
tensioning spring is reacted against the animal or human, causing
the skin to be stretched taut across the skin tensioner. This
stretching of the skin across the skin tensioner will position the
target area of the skin at a right angle to the syringe and the
nozzle. The movement of the inner housing to the firing position
also results in the movement of a protrusion relative to the inner
housing such that the protrusion no longer obstructs the movement
of the trigger. The user then simply presses the trigger, which
releases the spring driven hammer, which in turn drives the fluid
through the nozzle of the syringe and into the animal or human's
skin.
[0019] The hammer may drive a separate plunger with a seal through
the syringe to expel the fluid in the syringe through the nozzle of
the syringe. However, the syringe may incorporate portions, or all,
of the plunger to deliver different amounts of medicament into the
skin.
[0020] Still further, it is contemplated that the use of a separate
plunger will allow the use of a mechanical cocking device that will
push against the hammer to move the hammer from an unloaded
position to the cocked position.
[0021] According to these and other aspects there is provided a
needle-less injector device for delivering a dose of fluid
intradermally, subcutaneously or intramuscularly to an animal or
human. The device includes an inner housing having opposed ends. A
syringe is disposed in one end of the inner housing. The syringe
includes a nozzle for delivering a dose of fluid held within the
syringe. A plunger is movably disposed within the syringe. A spring
powered hammer is movably disposed within the inner housing. The
hammer cooperates with the plunger to drive the dose of medicament
from the nozzle. An injection delivery spring for powering the
hammer is positioned and compressed between the other end of the
inner housing and the spring powered hammer. An outer housing
slideably supports the inner housing. A skin tensioning spring is
mounted between the inner housing and the outer housing, the skin
tensioning spring biasing the nozzle of the syringe against the
animal or human. A trigger mechanism is disposed in the outer
housing, the trigger mechanism cooperating with the spring powered
hammer to release the injection delivery spring, wherein the size
of the injection delivery spring, skin tensioning spring and the
length of the hammer dictate the amount of dose delivered and
whether the dose is delivered intradermally, subcutaneously or
intramuscularly to an animal or human.
[0022] According to these and other aspects there is provided a
method for delivering a dose of medicament intradermally,
subcutaneously or intramuscularly to an animal or human. The method
includes the steps of providing a syringe containing a
predetermined dose of medicament, the syringe including a nozzle
for delivering the medicament and a skin tensioner, and providing a
needle-less injector device. The needle-less injector device
includes an inner housing having a leading end and a trailing end,
the leading end of the inner housing being adapted for receiving
the syringe; a hammer movably disposed within the inner housing; an
injection delivery spring disposed in the inner housing between the
hammer and the trailing end of the inner housing for driving the
hammer; a plunger movably and sealingly located within the syringe,
the plunger being driven by the hammer; a hollow outer housing
adapted for slideably receiving the inner housing therein, the
inner housing being movable within the hollow outer housing between
a safe position and a firing position; and a skin tensioning spring
mounted between the inner housing and the outer housing, the skin
tensioning spring biasing the nozzle toward the skin of the human
or animal. When the nozzle of the syringe is placed against the
skin, and the trigger is pressed, the hammer is released and the
hammer forces the plunger through the syringe to eject the fluid
from the syringe through the nozzle into the skin, wherein the size
of the injection delivery spring, skin tensioning spring and the
length of the hammer dictate the amount of dose delivered and
whether the dose is delivered intradermally, subcutaneously or
intramuscularly to an animal or human.
[0023] 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
[0024] FIG. 1 is a partial cutaway of the needless injector device
of the present invention.
[0025] FIG. 2 is a top view of the device of FIG. 1.
[0026] FIG. 3 is an exploded view of the needless injector device
of the present invention.
[0027] FIG. 4 is a cross-sectional view of the needless injector
device shown in the ready position, prior to moving the inner
housing into the firing position.
[0028] FIGS. 5-7 are a cross-sectional view of the needless
injector device of the present invention in the sequential firing
positions.
[0029] FIG. 8 is a cross-sectional view of the needless injector
device of the present invention in a post-injection position.
[0030] FIG. 9A is a perspective view of an embodiment of the
syringe and seal of the present invention.
[0031] FIG. 9B is a top view of the syringe and seal of FIG.
9A.
[0032] FIG. 10 is a perspective view of a carrying and cocking
device for the needle-less injection device of the present
invention.
[0033] FIG. 11 is a side view of the carrying and cocking device of
FIG. 7.
[0034] FIG. 12 is a rear isometric cross-sectional view of the
adjustable needless injector device.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0035] Referring to FIGS. 1-5, a hand-held, spring-powered,
needle-less injector device 10 includes an inner housing 12 having
a leading end 14 and a trailing end 16. The leading end 14 of the
inner housing 12 is constructed and arranged to receive a vial,
ampule or syringe 18 that is used to hold a fluid 20 that is to be
delivered through the skin 22 covering tissue of an animal or human
24 and into the tissue thereof. It should be appreciated that
although the present invention is described in relation to "skin"
and "animal," it is intended to include humans, animals and other
surfaces. As will be described further herein, the needle-less
injector of the present invention is designed to deliver the
medicament intramuscularly, intradermally or subcutaneously to the
human or animal. An intramuscular injection is one that passes
through the skin and subcutaneous tissue and penetrates the
underlying skeletal muscle. A subcutaneous injection is one that
fully penetrates the skin and is retained in the space between the
skin and the underlying musculature. An intradermal injection
floods the epidermal and dermal layers with fluid but does not
travel as deep as a subcutaneous injection. There are many reasons
why drug delivery to a particular location is important, for
example, speed of absorption, decreased side-effects, decreased
pain, etc. Moreover, some vaccines are formulated to be delivered
to the intramuscular area of the body, some are formulated for
subcutaneous and others can be administered to both areas and
others are targeted to the dentritic cells of the skin.
[0036] As shown in FIGS. 1-3, inner housing 12 is movably mounted
within an outer housing 28 so as to slide along the axial direction
thereof. The inner housing is movable from a ready position,
illustrated in FIG. 4, to a firing position, sequentially
illustrated in FIGS. 5-7.
[0037] Inner housing 12 can be moved into the ready position of
FIG. 4 by a skin tensioning spring 30 that is mounted between the
inner housing 12 and the outer housing 28. The skin tensioning
spring 30 has numerous functions. One function of spring 30 is to
cooperate with the structure of the syringe 18 to pull the animal's
skin 22 taut while positioning the skin 22 prior to delivering the
fluid 20 into the animal or human tissue 24. Another function of
the skin tensioning spring 30 is to cooperate with a trigger
mechanism 32 to ensure that the device 10 cannot be fired until the
device 10 is properly positioned against the skin 22 covering the
tissue of the animal or human 24, and the proper amount of pressure
or force exists between the syringe 18 and the skin 22.
[0038] The amount of force required to be applied against the skin
varies depending on the physical characteristics of the patient or
animal being injected with the device 10, as well as the location
of the delivery. For example, a mature adult may require higher
force to hold the skin taut and penetrate the skin as compared to a
child or infant, simply due to the effects of aging on the
elasticity of the skin. Likewise, in an animal, it can be more
difficult to inject the tougher skin surrounding the back or neck.
Accordingly, it is contemplated that the disclosed invention can be
manufactured with different skin-tensioning springs, each skin
tensioning spring 30 being of a stiffness that is appropriate for a
particular application. It is further contemplated that the force
imposed by the skin tensioning spring may be made adjustable, for
example by adding a threaded plug 33 that screws against the spring
30 to add pre-tension.
[0039] The amount of pressure or force that is used to hold syringe
18 against skin 22 is an important variable in the injection
process. Needle-less injection devices are capable of delivering
fluids through the skin 22 of the animal or human 24 by injecting a
jet of fluid 34 into the skin 22 at a sufficiently high pressure
and velocity so that fluid jet 34 penetrates through the skin 22
and into the tissue of the animal or human 24.
[0040] Important factors that contribute to the device's ability to
accomplish the task of forming a jet of fluid 34 are the amount of
energy that can be quickly and efficiently transferred to the fluid
jet 34, and the device's ability to position the fluid jet 34 such
that the energy of the jet is efficiently used to penetrate the
tissue.
[0041] The energy to be transferred to fluid 20 is stored in an
injection delivery spring 36 that drives a plunger and seal 38 into
the syringe 18 in order to force the fluid 20 through a nozzle 40
(FIG. 1) that forms the jet of fluid 34, as will be described more
fully herein. Injection delivery spring 36 is positioned between a
head 50 (FIG. 3) of a hammer 44 and the trailing end 16 of inner
housing 12.
[0042] In order to obtain the most efficient delivery of the jet of
fluid 34 into the skin 22 the nozzle 40 should be positioned at a
right angle relative to the skin 22 as the jet of fluid 34 is
delivered. Although the device may still operate at other angles,
delivering the jet of fluid 34 at some angle other than a right
angle could result in a component of the force with which the jet
of fluid strikes the skin could be parallel to the skin rather than
into the skin 22.
[0043] The stiffness of the skin-tensioning spring 30 is selected
such that the appropriate amount of force is imposed against the
skin 22 of the animal or human 24. The stiffness of the
skin-tensioning spring 30 is calculated from the well-known
formula:
F=k*x,
[0044] where F is the required force at the firing position, x is
the distance of travel (FIG. 4) of the inner housing 12 relative to
the outer housing 28 to position the device in the firing position
(where the protrusion 46 does not impede movement of the trigger
mechanism 32), and k is the spring constant of the skin-tension
spring 30.
[0045] Although, the present invention is described in particular
to positioning the device directly against the skin, it should be
appreciated that the above parameters can be chosen to deliver the
jet of fluid through the fabric of a patient. For example, in the
case of a pandemic outbreak or a terrorist attack, the medicament
can be delivered directly to the patient without the need to remove
potentially protective clothing. Also, in the application of a
resuscitation agent, the device of the present invention could be
used by emergency medical personnel to quickly deliver the
resuscitation agent directly through the patient's clothing without
the need to take the potentially life threatening time to expose
the patient's skin
[0046] For delivery through the skin surface, syringe 18 can
include a skin tensioner 42 that surrounds nozzle 40. Skin
tensioner 42 can be a disc positioned approximately about the
nozzle exit. It should be appreciated that skin tensioner 42 can
take other shapes.
[0047] As shown in FIGS. 3 and 9B, an installation ring 41 can be
provided on syringe 18. The installation ring 41 aids the user in
the insertion of syringe 18 into the device 10 and in positioning
the device 10 at a right angle to the skin as the jet of fluid 34
is to be delivered. The skin tensioner 42 may cooperate with the
installation ring 41 to pull the skin taut as the device is pressed
against the skin prior to delivery of the fluid jet 34. It should
be appreciated that a certain minimum amount of force must be
applied against the skin in order to ensure that the skin is drawn
tight prior to the release of the jet of fluid 34.
[0048] Referring to FIGS. 1-8, injection delivery spring 36 has
opposed ends. One end of spring 36 abuts against the trailing end
16 of the inner housing. The other end of spring 36 abuts against
head 50 of hammer 44. Hammer 44 in turn abuts against plunger and
seal 38. It should be appreciated that hammer 44 and plunger 38,
although illustrated as two separate pieces, can also be formed of
a single piece.
[0049] Plunger 38 is movably and sealingly disposed in syringe 18.
Thus, while plunger 38 can move within the syringe it is sealingly
engaged with an inner diameter of the syringe such that the dose of
medicament cannot leak therefrom. As shown in FIG. 3, the spring
powered hammer 44 rides within a sleeve 47 that includes a slot 49
for accepting latching components of the trigger mechanism 32.
[0050] Outer housing 28 includes an aperture 56. A trigger
mechanism 32 is mounted in inner housing 12 and protrudes through
aperture 56 so as to be engageable by a user. Trigger mechanism 32
includes a trigger 45 and a link 58 that controls the release of
hammer 44. As can be understood from comparing the sequential
illustrations of FIGS. 4-8, the firing of the device 10 to deliver
a dose of fluid is accomplished by pressing the trigger 45 in the
direction of arrow 48 after the device 10 is in the firing
position, illustrated in FIG. 5. However, the trigger 45 of the
trigger mechanism 32 can only release the plunger and seal 38 when
the device 10 is in the firing position, illustrated in FIG. 5.
When the device 10 is in another position (other than the firing
position), such as the ready position of FIG. 4, the trigger link
58 of mechanism 32 cannot be pressed to release the hammer 44. The
release of the hammer 44 is prevented for safety and for efficacy
of the injection.
[0051] The unwanted activation of the trigger mechanism 32 is
accomplished by positioning a protrusion 46 below trigger 45. The
protrusion 46 prevents movement of the trigger 45 in the direction
of arrow 48, preventing the release of hammer 44, and thus
preventing the firing of the device 10. According to a preferred
embodiment of the invention the protrusion 46 extends from the
outer housing 28 to a location under the trigger 45. The protrusion
46 is positioned such that it interferes with the movement of the
trigger 45 until the device 10 is in the firing positions, as
illustrated in FIG. 5-7. After firing, the trigger 45 will be
returned to its original position (FIG. 8).
[0052] In the preferred example of the invention, the movement of
the inner housing 12 relative to the outer housing 28 moves the
position of the trigger 45 (which is mounted from the inner housing
12) relative to the outer housing 28, which holds the protrusion
46. The amount of movement of the outer housing 28 relative to the
inner housing 12 is accomplished against the force of the
skin-tensioning spring 30.
[0053] As shown in FIG. 6, once the inner housing 12 is positioned
relative to the outer housing 28 such that the desired amount of
skin tensioning force is applied to the skin 22 against the syringe
18, which also positions the device in the firing position, the
pressing of the trigger 45 causes the release of the spring powered
hammer 44 from the cocked position. When the trigger is released,
injection delivery spring 36 that has been manually compressed and
latched to temporarily store the energy until it is required fire
the injector.
[0054] Referring to FIG. 7, when the trigger mechanism is pressed,
spring 36 is released and hammer 44 is propelled against plunger 38
located in the syringe, vial or ampule 18. The hammer drives
plunger 38 against the medicament, producing a high pressured jet
for injection purposes. The plunger expels the medicament from a
discharge orifice of nozzle 40 and into the patient's skin, muscle
and/or subcutaneous tissue.
[0055] The initial high pressure discharge causes the jet stream to
pierce the skin with the initial injection of the medicament. After
a short travel, the expansion of injection delivery spring 36 is
completed and the continued movement of hammer 44 and the movement
of plunger 38 into the syringe is driven by tensioning spring 30
(FIG. 8). This movement continues the ejection of the jet of
medicament from syringe 18 through the aperture in the skin created
by the initial high intensity burst. Skin-tensioning spring can
have a lower stiffness than the injection delivery spring.
[0056] Thus, the medicament can be delivered to a predetermined
depth beneath the surface, depending upon the magnitude of the
pressure. After the minute opening in the skin has been produced,
the pressure of the stream is immediately reduced to a lower second
stage for completing transfer of the remaining medicament from the
syringe.
[0057] It is desirable that the needle-less injector of the present
invention have adjustments for the delivered volume of the
medicament. Injection delivery spring 36 can be chosen from a
variety of spring weights to provide different spring pressures and
hence different delivery power of the medicament. As discussed
above, the present invention is designed so as to offer different
locations for the delivery of the medicament--intramuscularly,
intradermally or subcutaneously to the human or animal. A spring
having a lighter weight will accommodate a smaller dose or a dose
to a subject that has thinner skin, whereas a spring having a
larger weight can deliver a larger dose of medicament or a dose to
a subject with thicker skin. As with the tensioning spring 30, a
particular delivery spring 36 can be chosen by the user and be
delivered in the packaged injector. Spring weights can range from
850 and above, more particularly, from 850 to 1980. However, spring
weights vary in size and strength according to the tissues injected
and it should be appreciated that a variety of springs are
contemplated by the present invention and the disclosed range is
only an example.
[0058] Syringe 18 includes the dose of medicament to be delivered.
Depending on the type of vaccine and the intended recipient, a
particular dose is predetermined by the manufacturer of the
medicament or a physician. Typical vaccine dosages range of and
about 0.1-1 cc.
[0059] However, recent clinical trials have proven that for some
vaccines, reducing the amount of vaccine delivered still achieves
the desired level of efficacy as a larger dosage. Another manner in
which the needless-injector of the present invention can be used to
provide custom injections is to deliver smaller doses of the
medicament. In order to accommodate different doses of medicament,
the length of the hammer 44 can be varied to accommodate a variety
of volumes of doses. For example, a longer length hammer causes the
plunger to extend further within syringe 18, decreasing the volume
of medicament retained in the syringe 18 prior to ejection from the
vial 18. The firing of the injector will dispense a smaller amount
of medicament in a shorter time than a shorter length hammer,
because the plunger will have less of a distance to travel within
syringe 18. The present invention contemplates a delivery range of
dose of and about 0.1 cc to 1 cc. However, it should be appreciated
that other doses are contemplated by the present invention.
[0060] Thus, different doses can be accommodated by the present
invention without providing different sized syringes. By
lengthening hammer 44, the dosage in syringe 18 can be reduced
significantly, for example as low as 0.1 cc. This provides a
significant cost advantage. Importantly, lower doses also enable
smaller animals and infants to be inoculated. By adjusting the
length of hammer 44 and providing a particular delivery spring the
amount of dosage and the location of delivery can allow for a
custom injection. The length of the head of the hammer is increased
in proportionately for the stroke. For example, for a 0.1 cc dose,
the length of the hammer is increased by 4/5ths of the stroke.
[0061] Syringe 18 can include a plurality circumferential
stiffening ribs 52 (FIGS. 9A-9B) that extend around a body 54 of
syringe 18. These stiffening ribs help reduce the amount of
deflection of the body 54 of the syringe 18 during the delivery of
an injection.
[0062] As discussed above, disposable syringe 18 contains a dose of
liquid formulation for delivery. Syringe 18 can be made of a
readily injection moldable material, such as a pharmaceutical grade
polypropylene or a polymer material. One example of such a polymer
material is TOPAS.RTM., manufactured by Ticona Engineering
Polymers, a division of Celanese. As discussed above, medical grade
materials allow for factory pre-filling without-interaction with
the dose as opposed to filing on site just prior to injection.
[0063] Typically polypropylene is extremely difficult to engineer
because of pressure distortion. However, the design of the plunger,
syringe and the resulting seal of the present invention overcomes
previous manufacturing difficulties.
[0064] Referring to FIGS. 10 and 11, it should be understood that
the disclosed needle-less injection device can be used with a
combined cocking and carrying device 60. The cocking and carrying
device includes a cocking hammer 62 that is used to push the spring
powered hammer 44 back to the "ready" position shown in FIG. 4. The
cocking and carrying device 60 also includes a cradle 64 that
retains the outer housing 28 while the cocking hammer 62 is pushed
against the spring powered hammer 44.
[0065] Cocking hammer 62, when pushed against spring powered hammer
44, moves the hammer into the "ready" position illustrated in FIG.
4. It should be understood that the cocking and carrying device 60
will cock the needle-less injection device 10 once the device is
positioned in the cradle 64 and the cocking and carrying device 60
is closed. Thus, device 60 will serve as both a cocking device and
case for transporting and storing the needle-less injection device
10.
[0066] In operation, depending on the end use, the user selects an
injection device with the appropriate skin pre-tension spring 30,
injection delivery spring 36, and hammer length. Syringe 18
contains the desired amount of fluid to be delivered into the skin,
muscle or tissue of the animal or human. The syringe 18 will be
inserted into the leading end 14 of the inner housing 12,
preferably through the use of a bayonet-type connector, and mated
to a seal that may be a part of the plunger and seal 38.
[0067] The outer housing 28 and a cocking and storage mechanism
(FIGS. 10 and 11) for use with the device 10 will be color coded to
inform the user of the inner spring power, i.e., the injection
power, for that particular injector device 10.
[0068] The variation of the skin pre-tension spring 30, hammer
length and injection delivery spring 36 allows the needle-less
injector device 10 to be tailored for a particular application. For
example, a needle-less injector device 10 for use on a child would
have one particular combination of skin pre-tension spring 30,
hammer length and injection delivery spring 36, while the
combination of skin pre-tension spring 30 and injection delivery
spring 36 for an adult male would likely be a different
combination. Accordingly, the disclosed invention can the adapted
for use on a variety of animals or humans, and for the delivery of
a variety of types injections or depth of delivery of the fluid by
varying the skin pre-tension spring 30 and injection delivery
spring 36.
[0069] As described above, the user will press the face of the
syringe against the skin, or fabric, and depress the trigger to
give the injection. The injector inner housing slides inside the
outer housings, which creates an interlock so that the device
cannot be operated until the proper tension against the skin is
established. When the trigger is pressed, the trigger latch will
release the hammer and the hammer will move the syringe seal into
the syringe. The main pressure spring will deliver enough pressure
to allow the liquid to pierce the skin.
[0070] After the injection has taken place, the syringe is removed
and discarded. With a single dose injector because of the tight
seal between the plunger and syringe, the syringe is not reusable.
The injector is then placed into the cocking mechanism and reloaded
for the next injection.
[0071] The syringe and seal assembly can be pre-filled or field
filled with the use of an adapter and a break-away plunger. Thus,
syringe 18 can come pre-filled with the desired dose and type of
vaccination and inserted into the injector. Although the above has
been described for the use of a fixed dosage, it should also be
appreciated that a multi-dose syringe/injector is also contemplated
by the present invention. The end of the syringe is constructed
such that it can be coupled with a field-filling adaptor to
download on-site medicaments from a single dose or multi-dose vial
or secondary drug-container.
[0072] The syringe of the present invention is also constructed and
arranged in such a manner that the drug within the syringe can be
lyophilized so that is can be rehydrated with an adjuvant or saline
using the filed filling adaptor of co-pending U.S. patent
application Ser. No. 11/453,249, the subject matter of which is
herein incorporated by reference. In other words, an adjuvant or
saline can be downloaded into the syringe of the present invention
that is filled with a lyophilized product and rehydrated.
[0073] Although the present invention has been described in
relation to particular embodiments thereof, many other variations
and modifications 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.
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