U.S. patent number RE42,463 [Application Number 10/627,552] was granted by the patent office on 2011-06-14 for single-use needle-less hypodermic jet injection apparatus and method.
This patent grant is currently assigned to Bioject, Inc.. Invention is credited to Sergio Landau.
United States Patent |
RE42,463 |
Landau |
June 14, 2011 |
Single-use needle-less hypodermic jet injection apparatus and
method
Abstract
A gas-powered, single-use, needle-less hypodermic jet injection
device includes a hand-held injector, and a drug injection
cartridge which provides a cylinder of liquid medication to be
injected, an injection orifice, and an injection piston. Forceful
movement of the injection piston in the cylinder causes an
injection jet of medication to be expelled from the injection
orifice. The injection device also includes a hermetically sealed
gas pressure capsule which remains sealed until the moment of
injection and powers the jet injection after opening of this
cartridge.
Inventors: |
Landau; Sergio (Laguna Niguel,
CA) |
Assignee: |
Bioject, Inc. (Tualatin,
OR)
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Family
ID: |
22954735 |
Appl.
No.: |
10/627,552 |
Filed: |
July 24, 2003 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
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09195334 |
Nov 18, 1998 |
6096002 |
|
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Reissue of: |
09252131 |
Feb 18, 1999 |
6264629 |
Jul 24, 2001 |
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Current U.S.
Class: |
604/68; 604/143;
604/69 |
Current CPC
Class: |
A61M
5/30 (20130101); A61M 2005/3132 (20130101); A61M
2005/2073 (20130101); A61M 5/2053 (20130101); A61M
5/31511 (20130101); A61M 2005/2462 (20130101); A61M
5/2459 (20130101) |
Current International
Class: |
A61M
5/30 (20060101); A61M 37/00 (20060101) |
Field of
Search: |
;604/68-72,140,141,143,148,232,131 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Other References
Vitajet Industria e Comercia Ltda. Ommijet sales brochure, 4 pp,
Rio de Janeiro, Brazil, undated. cited by other.
|
Primary Examiner: Sirmons; Kevin C
Assistant Examiner: Gilbert; Andrew M
Attorney, Agent or Firm: Schwabe, Williamson & Wyatt,
P.C.
Parent Case Text
CROSS REFERENCE TO RELATED APPLICATION
This application is a Continuation-in-Part of U.S. patent
application Ser. No. 09/195,334, filed Nov. 18, 1998, now U.S. Pat.
No. 6,096,002.
Claims
I claim:
1. A needle-less hypodermic jet injection device comprising: a
pre-filled drug injection cartridge including: a medication
cylinder having an outlet orifice, an injection nozzle, a flow path
communicating the outlet orifice to said injection nozzle, a
drug-injection piston in a first position cooperating with said
medication cylinder to define a variable-volume chamber of first
selected size, a dose of substantially incompressible liquid
medication substantially filling said variable-volume chamber at
said first size with substantially no ullage volume, said
drug-injection piston having a second position cooperating with
said medication cylinder to define a variable-volume chamber of
second selected size smaller than said first selected size; a hand
piece assembly having a body holding said drug injection cartridge,
said hand piece assembly including a source of pressurized gas, and
means for selectively applying force from said pressurized gas to
said drug injection piston to move said drug injection piston from
said second position to a third position substantially ejecting
said dose of liquid medication via said injection nozzle; said hand
piece assembly including a first body portion holding said drug
injection cartridge, and a second body portion manually movable
relative to said first body portion, said second body portion
including an abutment member selectively movable into engagement
with said drug injection piston in response to manual relative
movement of said first and second body portions to move said drug
injection piston from said first position to said second
position.
2. The device of claim 1, wherein said hand piece assembly further
includes a first bore within said first body portion, a gas power
piston movably received in said bore and having a ram portion
extending into said drug injection cartridge to abut with said
drug-injection piston, said body and gas-power piston cooperating
to define a first variable-volume gas-power chamber in said first
bore; said hand piece assembly further including a second body
portion adjustably engaging with said first body portion, said
second body portion defining an elongate second bore in gas flow
communication with said first bore gas-power chamber and separated
therefrom by a wall portion carried by said second body
portion.
3. The device of claim 2 wherein said first body portion and said
second body portion are threadably and adjustably engaged with one
another, said second body portion carrying said abutment
member.
4. The device of claim 3 wherein said wall portion includes said
abutment member.
5. The device of claim 2 wherein said second body portion in said
second bore further carries a cylindrical gas capsule, said
cylindrical gas capsule providing said source of pressurized
gas.
6. The device of claim 5 wherein said hand piece assembly second
body portion is cylindrical, and a tubular trigger sleeve is
movably carried by said second body portion to effect opening of
said gas capsule.
7. A needle-less hypodermic jet injection device comprising: a
pre-filled drug injection cartridge including: a medication
cylinder having an outlet orifice, a plug member in a first
position sealingly closing the outlet orifice, an injection nozzle,
a flow path communicating the outlet orifice to said injection
nozzle and providing a chamber for capturing said plug member in a
second position, a drug-injection piston in a first position
cooperating with said medication cylinder to define a
variable-volume chamber of first selected size, a dose of
substantially incompressible liquid medication substantially
filling said variable-volume chamber at said first size with
substantially no ullage volume, said drug-injection piston having a
second position cooperating with said medication cylinder to define
a variable-volume chamber of second selected size sufficiently
smaller than said first selected size that said plug member is
hydraulically forced from said first position at said outlet
orifice and to a second position in said chamber; a hand piece
assembly having a two-piece body having a first body portion
holding said drug injection cartridge, and a second body portion
providing an abutment movable relative to said first body portion
to move said drug injection piston between said first and second
positions; a source of pressurized gas including a hermetically
sealed metallic gas capsule; trigger means for selectively
penetrating said gas capsule and for applying force from said
pressurized gas to said drug injection piston to move said drug
injection piston from said second position to a third position
substantially ejecting said dose of liquid medication via said
injection nozzle.
8. The device of claim 7, wherein said first body portion defines a
first bore, a gas-power piston movably received in said first bore,
said gas-power piston having a piston head and a ram portion
extending into said drug injection cartridge to abut with said
drug-injection piston, said first body portion and said gas-power
piston cooperating to define a first variable-volume gas-power
chamber in said first bore; said second body portion sealingly and
movably engaging with said first body portion to bound said
gas-power chamber, said second body portion defining an elongate
second bore in gas flow communication with said gas-power chamber,
and said gas capsule being received into said second bore.
9. The device of claim 8 wherein said first body portion and said
second body portion are threadably and adjustably engaged with one
another, said second body portion including said abutment on a wall
portion separating said second bore from said gas-power
chamber.
10. A jet injection device comprising: a drug cartridge having a
cylinder in which is movable a piston to cooperatively define a
variable-volume chamber for holding a dose of liquid medication; a
fine-dimension injection orifice in liquid flow communication with
the variable-volume chamber to receive the liquid medication and
discharge this medication as a high velocity forceful jet for
hypodermic jet injection of the medication upon forceful movement
of said piston in said cylinder; a power source for forcefully
moving said piston in said cylinder in response to triggering of
said injection device, and a trigger assembly for initiating
forceful movement of said piston, said trigger assembly including a
hammer member having a plurality of legs each having an end
surface, a sear ring member upon which said end surfaces of said
legs rests in a first position of the hammer member, means for
urging said hammer member to a second position, and a trigger
sleeve surrounding said hammer member and having a respective
plurality of contact portions each engaging one of the plurality of
legs to move said legs out of engagement with said sear ring upon
axial movement of said trigger member.
11. The injection device of claim 10 wherein said hammer member
includes a central wall portion from which extends in one axial
direction a skirt defining a spring seat, said power source
including a spring received into said skirt and into engagement
with said central wall portion, said multitude of legs extending
axially from said central wall portion in an opposite axial
direction.
12. The injection device of claim 11 wherein said hammer member is
a unitary molding of plastic polymer.
13. The injection device of claim 10 wherein said hammer member
includes a first circular cylindrical portion and a second
conically flaring portion axially arranged with one another.
14. The injection device of claim 13 wherein said first circularly
cylindrical portion extends in one direction from said central wall
portion, and said plurality of legs cooperatively define said
second conically flaring portion and extend axially in said
opposite axial direction from said central wall portion.
15. The injection device of claim 14 wherein said conically flaring
portion has a conical diameter at an end of said hammer member,
said plurality of legs are each part-circular segments having
circular radii which are substantially equal to the radius of the
circular cylindrical portion, whereby, said sear ring has an inner
diameter substantially equal to said circular cylindrical portion
of said hammer member and said plurality of legs in a second
position are nested circumferentially adjacent to one another
within said sear ring member.
16. A unitary elongate molded plastic polymer hammer member, said
hammer member comprising: a central wall portion extending
radially; a circular cylindrical portion extending axially in one
direction from said central wall portion, said circular cylindrical
portion including a tubular skirt and cooperating with said central
wall portion to define a spring seat into which a spring may be
received to engage upon said central wall portion; a conically
flaring portion extending in an opposite axial direction from said
central wall portion, said conical portion including a plurality of
circumferentially spaced apart resilient legs each extending
axially to terminate in a respective axial end surface engageable
with a sear ring in a first position of the legs to support said
hammer member in opposition to force from the spring exerted on
said central wall portion, said legs in said first position
cooperatively defining a conical diameter at said end surfaces, and
said legs at said end surfaces each also defining a circular radius
which are substantially equal to the radius of said circular
cylindrical portion; whereby, said plurality of legs are movable to
a second position in opposition to said resilience of said legs, in
said second position said plurality of legs being circumferentially
nested adjacent to one another and cooperatively defining a
diameter substantially equal to that of said cylindrical
portion.
17. A method of operating a needle-less hypodermic jet injection
device using an injection cartridge having a cylinder receiving
liquid medication, an orifice for forming the liquid into a
high-velocity hypodermic injection jet, a plug member in a first
position sealingly separating said medication from said orifice,
and said plug member in a captive second position allowing
communication of medication to said orifice, and an injection
piston movable sealingly in said cylinder to displace said liquid
medication via said orifice; said method including steps of:
providing said device with a two-piece body having a first body
portion defining a first bore into which is received a gas-power
piston, and a second body portion defining a second bore into which
is sealingly and movably received a hermetically sealed pressurized
gas capsule; utilizing said first and second body portions and said
gas-power piston to cooperatively define a variable-volume chamber;
and first relatively moving said first and second body portions to
forcefully move said plug member from said first position to said
captive second position to unseal said injection cartridge, and
then utilizing communication of pressurized gas from said
pressurized gas capsule into said variable-volume chamber to
forcefully move said gas-power piston to displace said liquid
medication from said cartridge via said orifice to effect a
hypodermic jet injection.
18. The method of operating a needle-less injection device of claim
17 further including the step of utilizing a unitary molded plastic
polymer hammer member to drive said gas capsule upon an impaling
spike communicating pressurized gas to said variable-volume
chamber.
19. A method of operating a needle-less hypodermic jet injection
device using an injection cartridge having a cylinder receiving
liquid medication, an orifice for forming the liquid into a
high-velocity hypodermic injection jet, a plug member sealingly
separating said medication from said orifice, and an injection
piston movable sealingly in said cylinder to displace said liquid
medication via said orifice; said method including steps of:
providing said device with a two-piece body having a first body
portion defining a first bore into which is received a gas-power
piston, and a second body portion defining a second bore into which
is sealingly and movably received a hermetically sealed pressurized
gas capsule; utilizing said first and second body portions and said
gas-power piston to cooperatively define a variable-volume chamber;
and first relatively moving said first and second body portions to
forcefully move said plug member to unseal said injection
cartridge, and then utilizing communication of pressurized gas from
said pressurized gas capsule into said variable-volume chamber to
forcefully move said gas-power piston to displace said liquid
medication from said cartridge via said orifice to effect a
hypodermic jet injection; further including the step of providing
said molded unitary plastic polymer hammer member with a plurality
of axially extending legs each having an end surface engaging upon
a sear ring surface to support said hammer member, and
simultaneously slipping said plurality of legs off of said sear
ring surface radially inwardly to be received in circumferentially
adjacent nested position within said sear ring surface to allow
axial movement of said hammer member.
20. A needle-free hypodermic jet injection device comprising: a
body substantially formed of plastic polymer; a jet injection
cartridge carried by said body and including a cylinder and piston
cooperatively defining a variable-volume chamber receiving a dose
of liquid medication, and a fine-dimension jet injection orifice in
liquid flow communication with said variable volume chamber; a
metallic pre-filled hermetically-sealed single-use gas pressure
cartridge axially movably disposed in said body, said gas pressure
cartridge having a penetrable wall portion and said body including
a penetrator axially spaced from and confronting said penetrable
wall portion for penetrating said penetrable wall portion of said
gas cartridge and releasing pressurized gas from said cartridge;
said device further including means responsive to pressurized gas
released from said gas pressure cartridge for applying force to
said liquid medication to eject said medication via said jet
injection orifice; said device further including means for
selectively moving said gas pressure cartridge axially and impaling
said gas pressure cartridge at said penetrable wall portion upon
said penetrator in response to a singular user input so as to
release pressurized gas from said gas pressure cartridge and to
eject said medication via said jet injection orifice to effect a
hypodermic jet injection.
.Iadd.21. A needle-less injection device, comprising: a liquid
container having an outlet orifice; an injection orifice fluidly
coupled with the outlet orifice and configured to inject liquid
forwardly out of the needle-less injection device substantially
along an injection axis into an injection site; a plug member
displaceable from a first position, in which it sealingly closes
the outlet orifice, to a second position, in which liquid is
permitted to flow out of the outlet orifice; and plural bypass
conduits defined between the outlet orifice of the liquid container
and the injection orifice in a plug capture chamber when the plug
member is in the second position, the plural bypass conduits being
defined by walls of the plug capture chamber and the plug member
such that the bypass conduits permit liquid to flow from the outlet
orifice past the plug member to the injection orifice, where a
portion of the walls of the plug capture chamber extend at acute
angles relative to a portion of the injection axis extending along
the bypass conduits..Iaddend.
.Iadd.22. The device of claim 21, where the plug member moves
forwardly along the injection axis when displaced from the first
position to the second position..Iaddend.
.Iadd.23. The device of claim 21, where the bypass conduits
converge forwardly of the plug member when the plug member is in
the second position, such that streams of liquid flowing past the
plug member through the bypass conduits converge into a single
stream between the plug member and the injection
orifice..Iaddend.
.Iadd.24. The device of claim 21, further comprising a plurality of
ribs extending radially inward from the wall of the plug capture
chamber..Iaddend.
.Iadd.25. The device of claim 24, where the bypass conduits are
defined by the ribs, the wall of the plug capture chamber, and by
the plug member when the plug member is in the second
position..Iaddend.
.Iadd.26. The device of claim 25, where the plug member moves
forward along the injection axis when displaced from the first
position to the second position, and where the ribs are configured
to block the plug member from further forward movement toward the
injection orifice when the plug member is in the second
position..Iaddend.
.Iadd.27. A needle-less injection device, comprising: a liquid
container having an outlet orifice; an injection orifice fluidly
coupled with the outlet orifice and configured to inject liquid
forwardly out of the needle-less injection device substantially
along an injection axis into an injection site; a plug member
displaceable from a first position, in which it sealingly closes
the outlet orifice, to a second position, in which liquid is
permitted to flow out of the outlet orifice; and a plug capture
chamber interposed between and fluidly coupling the outlet orifice
with the injection orifice, the plug capture chamber being adapted
to receive and hold the plug member when the plug member is
displaced to the second position, so that the plug member does not
prevent liquid from flowing from the outlet orifice to the
injection orifice, where plural bypass conduits are defined within
the plug capture chamber such that, when the plug member is in the
second position, the bypass conduits permit liquid to flow from the
outlet orifice past the plug member to the injection orifice, and
where each bypass conduit is at least partially defined by a wall
of the plug capture chamber that extends non-perpendicularly
relative to the injection axis along the bypass
conduit..Iaddend.
.Iadd.28. The device of claim 27, wherein a portion of the wall of
the plug capture chamber that defines each bypass conduit extends
at an acute angle relative to a portion of the injection axis
extending along the bypass conduit..Iaddend.
.Iadd.29. The device of claim 27, where the plug member moves
forwardly along the injection axis when displaced from the first
position to the second position..Iaddend.
.Iadd.30. The device of claim 27, where the bypass conduits
converge forwardly of the plug member when the plug member is in
the second position, such that streams of liquid flowing past the
plug member through the bypass conduits converge into a single
stream between the plug member and the injection
orifice..Iaddend.
.Iadd.31. The device of claim 28, where the plug capture chamber
includes a plurality of ribs extending radially inward toward the
injection axis..Iaddend.
.Iadd.32. The device of claim 31, where the bypass conduits extend
between the ribs and are defined in part by the ribs..Iaddend.
.Iadd.33. The device of claim 32, where the plug member moves
forward along the injection axis when displaced from the first
position to the second position, and where the ribs are configured
to block the plug member from further forward movement toward the
injection orifice when the plug member is in the second
position..Iaddend.
.Iadd.34. A needle-less injection device, comprising: a liquid
container having an outlet orifice; an injection orifice fluidly
coupled with the outlet orifice and configured to inject liquid
forwardly out of the needle-less injection device substantially
along an injection axis into an injection site; and a plug member
displaceable from a first position, in which it sealingly closes
the outlet orifice, to a second position, in which liquid is
permitted to flow out of the outlet orifice, where the plug member
contacts a plug capture structure within a plug capture chamber
when in the second position, and where plural bypass conduits are
formed in the plug capture structure to permit liquid to flow from
the outlet orifice past the plug member to the injection orifice,
and where the bypass conduits are defined at least partially by
walls of the plug capture chamber and the plug member when in the
second position, the walls extending at acute angles relative to a
portion of the injection axis extending along the bypass
conduits..Iaddend.
.Iadd.35. A needle-less injection device, comprising: a container
having an outlet orifice; an injection orifice configured to inject
liquid forwardly out of the needle-less injection device
substantially along an injection axis into an injection site; and a
plug member displaceable from a first position, in which it
sealingly closes the outlet orifice, to a second position, in which
liquid is permitted to flow out of the outlet orifice and to the
injection orifice, where, in the second position, the plug member
abuts a plug capture structure disposed between the outlet orifice
and the injection orifice in a plug capture chamber, and where a
plurality of bypass conduits are formed in the plug capture
structure by walls of the plug capture chamber and the plug member
to permit liquid to flow from the outlet orifice around the plug
member along the plurality of bypass conduits that converge
forwardly of the plug member between the plug member and the
injection orifice, each bypass conduit being shaped so that, liquid
emerging from the bypass conduit into where the bypass conduits
converge flows in an acute direction relative to a portion of the
injection axis extending along the bypass conduits..Iaddend.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention relates generally to a single-use disposable
needle-less (or needle-free) hypodermic jet injection device.
Particularly, this invention relates to such a jet injection device
which comprises a hand-held injector having a pre-filled drug
cartridge sealingly carrying injectable medication, a sealed
cylinder of pressurized gas, a pre-energized discharge mechanism
for penetrating the gas cylinder, and a trigger device for
releasing the discharge mechanism. Features are provided which
simultaneously unseal the drug cartridge and prepare the device for
performing a jet injection when a user of the device changes it
from a storage configuration to a use configuration. When the user
actuated the injection device, the trigger device releases the
discharge mechanism to penetrate the gas cylinder, which drives a
piston of the drug cartridge to effect a hypodermic jet
injection.
2. Related Technology
Needle-less or needle-free hypodermic jet injection devices have
been in commercial use for over 40 years. A number of these devices
have used pressurized gas to power a hypodermic jet injection. The
related technology includes a number of teachings for gas-powered
injection devices, including: U.S. Pat. No. 4,596,556, issued Jun.
24, 1986 to J. Thomas Morrow, et al.; U.S. Pat. No. 4,913,699;
issued Apr. 3, 1990 to James S. Parsons; and U.S. Pat. No.
5,730,723, issued Mar. 24, 1998, to Thomas P. Castellano, et al.
WIPO publication WO 97/37705 also discloses a gas powered
disposable needle-less hypodermic jet injector.
The Morrow, et. al. '556 patent is believed to teach a reusable
hypodermic jet injection device in which a housing receives a shell
or cartridge having a bore leading to a discharge aperture. Within
the bore is received both a plunger sealingly engaging the bore,
and a pressurized gas cylinder which rests against the plunger. The
injection device includes a ram which has a penetrating tip
confronting a penetrable wall section and seal of the gas cylinder,
and a discharge mechanism for driving the ram through the
penetrable wall section of the gas cylinder when a trigger device
is released. Discharge of the pressurized gas from the cylinder
drives the plunger to effect a jet injection, and also drives the
seal of the gas cylinder to effect resetting of the discharge
mechanism. The shell with its plunger, and spent gas cylinder, is
discarded after an injection; and a new shell pre-filled with
medication and with a new gas cylinder is used for each
injection.
The Parsons '699 patent is believed to teach a single-use jet
injector which is totally discarded after one use. This injector is
believed to have a body with a pair of gas chambers separated by a
breakable valve. One of the gas chambers contains a pressurized
gas, while the other chamber is sealingly bounded by a piston which
drives a plunger. The plunger sealingly bounds a chamber into which
a dose of medication is loaded by the user before the injection.
This medication dose chamber leads to an injection orifice so that
when the valve is broken, the piston and plunger are moved by
pressurized gas communicated to the second chamber, and the plunger
drives the medication forcefully out of the injection orifice to
form an injection jet. After a single use, the device is
discarded.
The Castellano '723 patent, which was issued in 1998 and which does
not cite the earlier Parsons '699 patent, is believed to teach
substantially the same subject matter as Parsons et al.
WIPO publication WO 97/37705 published pursuant to a Patent
Cooperation Treaty (PCT) application for joint inventors Terence
Weston and Pixey Thornlea, is believed to disclose a disposable
hypodermic jet injector in which the device is powered by a gas
pressure spring of the type common in the tool and die art as a
substitute for the conventional metal spring-powered ejector pin.
In the Weston device, the ram of the gas pressure spring is held in
a contracted position by a trigger mechanism. When the trigger
mechanism is released, the gas pressure spring is supposed to
expand and drive a piston sealingly received in a bore and leading
to a fine-dimension orifice in order to produce a jet hypodermic
injection from liquid held in the bore ahead of the piston.
The Weston device is thought to have several deficiencies: such as
difficult and costly manufacturing and sterilization processes,
because pressurized gas and a drug dose need to be contained in the
same package; and including a possible inability to endure
long-term storage while still retaining the gas pressure in the gas
spring to power an injection, and also maintaining the medication
integrity. In other words, the gas pressure spring of the Weston
device contains only a small quantity of gas, and depends upon the
sealing relationship of the ram of this spring with a cylinder
within which the ram is movably and sealingly received in order to
retain this gas pressure. Even a small amount of gas leakage over
time will be enough to render this injector inoperative.
SUMMARY OF THE INVENTION
In view of the above, it is desirable and is an object for this
invention to provide a needle-less hypodermic jet injection device
which reduces the severity of or avoids one or more of the
limitations of the conventional technology.
Thus, it is an object of this invention to provide a single-use,
disposable, needle-free gas-powered hypodermic jet injector
utilizing a pressurized gas source which is hermetically sealed
until the moment of injection.
Further, an object of this invention is to provide such a gas
powered jet injector in which the device has a storage
configuration and a use configuration. In the storage
configuration, the device is safe, with the drug cartridge sealed
closed, and is incapable of effecting a jet injection. In the use
configuration, the device is prepared for making a jet injection,
with the drug cartridge opened in preparation for this
injection.
Additionally, an object for this invention is to provide such an
injection device having a multi-function component which
alternatively maintains the injector in a safe storage condition,
and also allows a user to place the injection device into a use
condition preparatory for performing a jet injection. When the user
placed the device into the use configuration, the multi-function
component prepares the jet injection device by effecting unsealing
of the previously sealed drug cartridge, and also removes a safety
block from an obstructing position relative to a trigger of the
device. Thereafter, the trigger of the injector can be manually
activated by a user of the device to perform an injection.
Accordingly, a needle-less hypodermic jet injection system
embodying this invention includes, for example: a hand piece
assembly having a body including a drug injection cartridge with a
medication cylinder pre-filled with substantially incompressible
liquid medication such that substantially no ullage volume exists
in said medication cylinder, said medication cylinder leading to an
outlet orifice a plug-capture chamber and a drug injection nozzle,
a sealing member sealingly and movably received in said outlet
orifice, and a drug-injection piston; the hand piece assembly
further defining a first bore within the body for movably receiving
a gas-power piston, a gas power piston movably received in the
first bore and having a ram portion extending into the drug
injection cartridge to abut with the drug-injection piston, the
body and gas-power piston cooperating to define a first
variable-volume chamber in the first bore; the body also defining
an elongate second bore in gas communication with the first bore
and separated therefrom by a center wall portion of the body, a
cylindrical gas capsule received into the second bore, the gas
capsule having a penetrable wall section disposed toward the center
wall, the center wall carrying a penetrator disposed toward the
penetrable wall section of the gas capsule, and the hand piece
assembly carrying a discharge mechanism including a trigger member
outwardly disposed on the body and a hammer movable in the body in
response to actuation of the trigger to forcefully move the gas
capsule in the second bore so as to impale the gas capsule at the
penetrable wall section thereof upon the penetrator and thus to
communicate pressurized gas to the first chamber; whereby, the
pressurized gas in the first chamber drives the gas-power piston to
effect a hypodermic jet injection from the drug injection
cartridge, and the body and trigger member cooperatively defining a
first relative position in which said ram portion confronts but
does not displace said injection piston so that said sealing member
is disposed in said outlet orifice to maintain said drug injection
cartridge sealingly closed, and said body and trigger member in a
second relative position preparatory to effecting a jet injection
causing said ram portion to abut and move said drug injection
piston to a second position displacing said drug injection piston
to a second position so that said sealing member is displaced from
said outlet orifice into said plug-capture chamber by said liquid
medication and unseals said drug injection cartridge.
Additional objects and advantages of this invention will appear
from a reading of the following detailed description of a single
exemplary preferred embodiment, taken in conjunction with the
appended drawing Figures, in which the same reference numeral is
used throughout the several views to indicate the same feature, or
features which are analogous in structure or function.
BRIEF DESCRIPTION OF THE DRAWING FIGURES
FIG. 1 provides an exterior side elevation view of a single-use,
needle-less hypodermic jet injector device embodying the present
invention, and in which the device is in a "storage"
configuration;
FIG. 2 is an exterior side elevation view of the injector device
seen in FIG. 1, but with the device shown in an "inject"
configuration preparatory to effecting a hypodermic jet
injection;
FIG. 3 provides a longitudinal cross sectional view through the
needle-less hypodermic jet injection device of FIG. 1, and shows
the device in the "storage" configuration;
FIG. 4 is a fragmentary cross sectional view similar to FIG. 3, but
shows the hypodermic jet injection device in the "inject"
configuration;
FIG. 5 is also a fragmentary cross sectional similar to FIGS. 3 and
4, but shows the hypodermic jet injection device during the process
of effecting a jet injection;
FIG. 6 is a fragmentary cross sectional view similar to a portion
of FIG. 4, but shows a respective portion of an alternative
embodiment of a single-use, needle-less hypodermic jet injection
device according to the present invention;
FIG. 7 is a perspective view of a portion of the device seen in
FIG. 6; and
FIG. 8 provides a cross sectional view of the portion of the device
seen in FIG. 7.
DETAILED DESCRIPTION OF EXEMPLARY PREFERRED EMBODIMENTS OF THE
INVENTION
Overview, Storage of the Device, and its Preparation for Effecting
a Jet Injection
Viewing FIG. 1, a needle-free, hypodermic jet injection device 10
is shown in a storage configuration in which it is maintained until
it is prepared for its use in administering an injection. In this
storage configuration, the device is incapable of effecting a jet
injection, is safe, and can be stored for a comparatively long time
while requiring only a moment of preparation before it can be used
to make a jet injection of the medication within the device 10.
The device 10 includes a hand piece assembly 12, preferably
fabricated principally of injection molded plastic polymers, and
with a body 12a including a pre-filled drug injection cartridge or
medication cylinder 14. The word "drug" as used herein is intended
to encompass, for example, and without limitation, any medication,
pharmaceutical, therapeutic, vaccine, or other material which can
be administered by jet injection. Essentially, such an injectable
medication is in the form of a substantially incompressible liquid,
and as will be seen, this liquid substantially fills the drug
injection cartridge so that no ullage volume of compressible gas is
present in this cartridge.
The pre-filled drug injection cartridge 14 has an end surface 16 at
which is defined a fine-dimension injection orifice or injection
nozzle opening 18. When the device 10 is used to effect an
injection, a high velocity jet of liquid medication issues from
this orifice (as is indicated by arrow 20 of FIG. 5). To use the
device 10, it is first placed in an "inject" configuration, the end
surface 16 is pressed against the skin of a patient who is to
receive the jet injection, and then the device 10 is triggered so
that the jet 20 issues out and penetrates the skin. Thus, the
liquid medication enters the tissues of the patient without the use
of a hypodermic needle.
Placing the device 10 in the "inject" configuration is effected
manually by a user of the device 10 who rotates a first portion 12b
of the body 12a relative to a second portion 12c. As is seen in
FIG. 1, the body portion 12c carries a trigger sleeve 22, while the
portion 12b carries a projection 24 abutting this sleeve. The
projection 24 and a blocking pin 26 cooperate to prevent the body
portions 12b and 12c from being relatively rotated except in the
direction of the arrow of FIG. 1. When a user effects this relative
rotation of the body portions 12b and 12c through a rotation of
almost 360.degree., then this relative rotation aligns the
projection 24 with a recess 28 on the trigger sleeve 22, reveals
the abbreviation of the word "inject" (indicated on FIG. 2 by the
letters "INJ") on the body portion 12c.
This relative rotation of the body portions 12b and 12c also
effects a selected relative axial movement of these body portions
toward one another (as will be further described below), and places
the device 10 in the "inject" configuration seen in FIG. 2. In this
"inject" configuration, the device 10 is positioned with its
surface 16 against the skin of the person who is to receive the
injection, and an axial pressure is applied to the trigger sleeve
22. The trigger sleeve 22 moves axially along the body portion 12c,
and this movement triggers the device 10 to effect injection jet 20
(recalling FIG. 5).
Structure of the Device 10
Turning now to FIGS. 3, 4, and 5, in conjunction with one another,
FIG. 3 shows the device 10 in the storage configuration of FIG. 1
preparatory to giving an injection. In FIG. 4 shows the device in
the "inject" configuration, and FIG. 5 shows the device during the
brief interval of an injection. In these Figures, it is seen that
the drug cartridge 14 includes a cylindrical body 30 defining an
external thread section 32. This external thread 32 is threadably
received by a matching internal thread section 34 of the body
portion 12b. Preferably, a thread locking compound, such as an
anaerobic adhesive, is applied to the threads 32 of the cartridge
14 when it is assembled to the body portion 12b during manufacture
of the device 10. Alternatively, a self-locking thread design or a
thread-locking feature may be used on the device 10 to prevent the
drug injection cartridge 14 from being removed from the device 10.
Thus, the cartridge is not removable from the device 10, and the
device 10 and cartridge 14 are disposed of after the first and only
injection effected with the device 10.
An advantageous feature of the device 10 embodying the present
invention, and one which results from this construction of the
device, is that the injection cartridge 14 may be manufactured and
filled at a drug company (without the drug manufacture having to be
concerned with handling capsules of pressurized gas), the gas
pressure capsule of the device may be manufactured and filled at a
factory devoted to this item (without this manufacturer having to
handle drugs), and the hand piece assembly of the device may be
manufactured at yet another location, if desired. Subsequently,
completion of the device 10 requires merely the combining of the
hand piece assembly, gas capsule, and drug injection cartridge.
The body 30 of cartridge 14 defines a stepped through bore 36
having a larger diameter portion 36a which extends substantially
the length of the body 26. Adjacent to the forward end of the body
30 (i.e., adjacent to the end defining surface 16), the bore 36
steps down and defines an outlet orifice 36b. It is seen that the
bore portion 36a and outlet orifice 36b are defined by a glass
sleeve 38 which is received into a molded plastic body 40. An
O-ring type of seal member 42 prevents leakage between the glass
sleeve 38 and the body 40.
As those who are ordinarily skilled in the pertinent arts will
understand, many medications are not suitable for long-term storage
in contact with plastics, but will store satisfactorily in contact
with glass. Thus, this construction of the cartridge 14 makes it
suitable for long-term storage of even medications of this nature.
However, for medications that will store satisfactorily in contact
with plastic polymers, this construction detail is optional and the
entire injection cartridge body 30 may be formed of a selected
polymer.
In the embodiment of cartridge 14 having the glass sleeve 38, the
outlet orifice 36b is sealingly closed in the storage configuration
of the device 10 by a plug 44. Importantly, viewing FIGS. 3-5, it
is seen that the cartridge 14 defines a plug-capture chamber 46
immediately outside of the outlet orifice 36b (i.e., rightwardly of
this outlet orifice, viewing FIGS. 3-5). The plug capture chamber
46 includes a radial array 46a of individual radially inwardly and
axially extending ribs 48 disposed in a spaced relation to the
outlet orifice 36b. These ribs 48 are arrayed radially about and in
a transition bore portion 18a leading to the injection orifice 18.
Thus, as will be seen, the plug member 44 can be received into the
plug-capture chamber 46 and be supported on the ribs 48 without it
blocking the injection orifice 18.
Sealingly and movably received in the bore section 36a is a
resilient piston member 50. This piston member defines multiple
circumferential grooves 50a interdigitated with sealing ribs 50b.
The sealing ribs 50b sealingly and movingly engages the bore 36a of
the injection cartridge (i.e., with the bore 36a of glass sleeve 38
in this case). The piston member 50 and body 30 cooperatively
define a medication chamber 52 communicating outwardly of the
cartridge 14 via the injection orifice 18. Prior to its use to
effect an injection, the orifice 18 of each fresh and pre-filled
device 10 will ordinarily also be sealed by an adhesively-applied,
peel-off type of sealing membrane, which may be formed, for
example, of foil or of a polymer/paper laminate. Such peel-off
seals are conventional and well known, and for this reason, the
seal formerly on cartridge 14 of device 10 as seen in FIG. 3 is not
shown in the drawing Figures.
Further considering the cartridge 14, it is seen that the piston
member 50 defines an abutment surface 54 confronting the opening of
bore 36 on body 30. This surface 54 is abutted by an end surface 56
on an injection ram of the hand piece assembly 12 (which injection
ram will be further described below). In the storage configuration
of the device 10, the end surface 56 confronts piston member 50,
but does not displace it from the position seen in FIG. 3. In this
storage configuration of the device 10, the chamber 52 is sealed
and is substantially full of incompressible liquid, without any
substantial ullage volume of compressible gas being in the chamber
52. The injection ram will be understood as effective during a jet
injection to forcefully move the piston member 50 inwardly of the
bore section 36a toward the outlet orifice 36b.
Hand Piece Assembly 12
Considering now the hand piece assembly 12 in greater detail, as
seen in FIGS. 1-5, it is seen that the body 12a generally is formed
of two main cooperative tubular sections 12b and 12c, which are
threadably engaged with one another to form the hand piece assembly
12. Preferably both of the body sections 12b and 12c, as well as
other components of the device 12 not otherwise identified as being
made of some other material, are all formed of plastic polymers.
Further, the preferred process for making the device 10 is by
injection molding of the components formed of plastic polymer, so
that manufacturing costs are very low. Materials utilization for
the device 10 is very small as well, so that disposing of the
device after a single injection does not cause a serious
environmental concern.
The forward tubular body section 12b defines a stepped through bore
58, a forward portion 58a of which opens at 58b forwardly on the
body 12, and which inwardly of this bore opening 58a defines the
internal thread section 34 for threadably receiving the external
threads 32 on the drug cartridge 14. Sealingly and movably received
in the bore portion 58a is a stepped injection piston member 60. A
larger diameter portion 60a of this piston member defines a groove
60b carrying a seal member 60c. The seal member 60c movingly
engages sealingly with the bore portion 58a and bounds a gas
pressure chamber 60d, which is to the left of this piston member as
seen in FIGS. 3, 4, and 5. It is to be noted that in FIGS. 3 and 4,
this chamber 60d is at a minimal volume, and so the lead line from
reference numeral 60d extends into the interface of the piston
member 60 with the housing portion 12c.
A smaller diameter portion 60e of the piston member 60 is elongate
and extends in the bore 58 to also be received into the bore
portion 36a of the drug cartridge 14, as is seen in FIG. 3 in the
storage configuration of the device 10. The piston portion 60e
defines the end surface 56 which confronts and abuts the surface 54
of the piston member 50 of an drug cartridge 14. Thus, the piston
portion 60e provides the injection ram of the device 10.
Considering the forward body section 12b in still greater detail,
it is seen that this body section defines a tubular aft body
section 62. This aft body section includes an axially disposed end
surface 62a at which the stepped through bore 58 opens, and which
defines an internal thread section 64 threadably engaging onto
matching threads 66 of body section 12c. For purposes of
explanation, and without limitation of the present invention, the
threads 64 and 66 may have a pitch of about 14 threads per
inch.
As is seen comparing FIGS. 1 and 2, the device 10 is converted from
its storage to its "inject" configuration by rotating the body
portions 12b and 12c in a relative rotational direction that
threads these body portions together along threads 64 and 66. As
was explained above, this relative rotation of the body sections
12b and 12c brings projection 24 into alignment with recess 28 on
trigger sleeve 22, and makes possible the subsequent triggering of
the device 10.
Still considering FIGS. 2 and 3, it is seen that the aft body
portion 12c outwardly defines the thread section 66 and slidably
carries the trigger sleeve 22. Adjacent to the thread section 66,
the body portion 12c carries an O-ring type of sealing member 68
which sealingly engages the body portion 12b both when the body
portions are in their "storage" relative configuration of FIG. 3,
and also when these body portions are in their "inject" relative
positions as is seen in FIGS. 4 and 5.
Body portion 12c defines a stepped through bore 70 which is
substantially closed at the end of this bore adjacent to the
forward body portion 12b by a wall member 72. This wall member 72
defines a stepped through bore 74 in a larger diameter part of
which is seated a disk part 76 of a penetrator member 78. This
penetrator member 78 includes a hollow penetrator spike 80 which
itself has a bore 80a communicating through the wall member 72 via
the smaller diameter portion of bore 74. Thus, the bore 70 is
communicated to the chamber 60d adjacent to injection piston 60 in
the body portion 12b.
Slidably received in the bore 74 adjacent to and confronting the
penetrator member 78 is a gas pressure capsule 82. This gas
pressure capsule 82 includes a body 82a, having a cylindrical outer
wall portion 82a'. The capsule 82 is also necked down at a forward
end to provide a reduced diameter portion 82b leading to an axially
disposed end surface 82cdefined by a penetrable wall section 82d
(the wall section being indicated by the arrowed numeral in FIG.
3). The gas capsule 82 is preferably formed of metal, and contains
a supply of pressurized gas. Because the pressurized gas is
contained in the capsule 82 until the moment of injection, the
plastic parts of the device 10 are not exposed to or stressed by
this pressurized gas until an injection is effected using the
device 10. For this reason, the device 10 is believed to have a
much more reliable storage life then prior devices which attempt to
contain pressurized gas in a plastic or plastic-composite
containment.
The wall section 82d confronts and is spaced slightly from the
penetrator spike 80. At an opposite or aft end of the capsule 82,
this capsule defines an outwardly rounded end wall 82e.
Also slidably received into the bore 70 and confronting the end 82e
of capsule 82 is tubular and cylindrical hammer member 84. This
hammer member 84 defines an end surface 84a which is engageable
with the surface 82e of capsule 82, an axially extending groove 86
having an end wall at 86a (into which a dowel pin 88 is received),
and an axial protrusion at 90 which serves to center a spring
92.
The dowel pin 88 is engaged in a first position (i.e., in the
"storage" configuration of the device 10) at end 86a of groove 86,
and the other end of this pin rests upon a metal (i.e., preferably
hardened steel) sear pin 94 carried by the body portion 12c. Thus,
as is seen in FIGS. 3 and 4, the hammer 84 is maintained in a
"cocked" position with the spring 92 pre-loaded between the hammer
84 and a spring seat member 96 threadably engaging into the end of
body portion 12c.
In order to provide for movement of the trigger sleeve 22 to effect
release of the hammer 84, the body portion 12c defines an axially
extending slot 100, and the trigger sleeve 22 carries a radially
inwardly extending trigger block 22a, which is slidably received in
this slot 100 and which confronts the dowel pin 88, as is seen in
FIG. 3. Also, an end cap 102 is adhesively retained onto the
trigger sleeve 22 and closes the end of this trigger sleeve so that
a user's thumb, for example, may be used to effect forward movement
of the trigger sleeve when an injection is to be effected. It will
be understood that the trigger sleeve 22 may alternatively be
grasped between the thumb and fingers, for example, to position the
device 10 for making an injection, and then effecting forward
movement of the trigger sleeve 22 to effect this injection.
However, as was pointed out above in connection to the comparison
of FIGS. 1 and 2, the device 10 is first placed by a user into its
"inject" configuration before a jet injection can be effected. This
conversion of the device 10 from its "storage" configuration to its
inject configuration is effected by relative rotation of the body
portions 12b and 12c, as is indicated by the arrow on FIG. 1. As is
seen in FIG. 2, this relative rotation of the body portions 12b and
12c brings the projection 24 into engagement with blocking pin 26
and into alignment with recess 28, so that the trigger sleeve 22 is
movable in the axial direction toward body portion 12b. However,
viewing FIG. 4, it is seen that this relative rotation of the body
portions 12b and 12c also threads body portion 12c by substantially
one thread pitch dimension into the body portion 12b.
Because the body portion 12c and wall member 72 are abutting
injection piston member 50, this piston member 50 is moved
rightwardly, viewing FIG. 4, by substantially one thread pitch
dimension. Consequently, the ram portion 60e of the injection
piston 60 moves forward and forces piston member 50 forwardly by a
sufficient amount that plug member 44 is dislodged hydraulically
(recalling that the liquid medication in chamber 52 is
substantially incompressible) from the outlet orifice 36b and into
plug-capture chamber 46. In this chamber 46, the plug member 44 is
retained an rests upon the ribs 48 while these rib provide a flow
path leading (indicated by arrow 20a in FIG. 5) around the plug
member 44 from the outlet orifice 36b to the injection orifice
18.
Although the conversion of device 10 from its "storage"
configuration to its "inject" configuration unseals the injection
cartridge 14, this is not detrimental to the integrity of the
medication in chamber 52 because it happens mere moments before the
device 10 is used to inject the medication into a patient. This
injection is effected by placement of the device 10 with its
surface 16 against the skin at the intended location of injection,
and sliding of trigger sleeve 22 forward (which also assists in
seeing that the device 10 is held firmly to the skin), so that the
trigger block 102 slides along slot 100 to dislodge the dowel pin
88 from sear pin 94, viewing FIG. 5.
As is seen in FIG. 5, the result is that the hammer member 84 is
driven forward by spring 92, impacts the capsule 82, and impales
this capsule at penetrable wall 82d, as is seen in FIG. 5. The
result is the penetrator spike 80 penetrates the wall 82c of the
capsule 82, and allows pressurized gas from this capsule to flow
along the bores 80a and 74 into the chamber 60d. This pressurized
gas in chamber 60d drives piston member 60 forwardly, so that the
piston member 50 in bore 36a is also driven forwardly. Forward
movement of piston member 50 drives the liquid medication out of
chamber 52, past the plug member 44 in plug-capture chamber 46, and
out of injection orifice 18, forming injection jet 20.
After the jet injection depicted in FIG. 5, the device 10 is
disposed of by the user of the device, and it is not again used.
That is, the device 10 is a single-use device and is not designed
or intended to be recharged or refilled. This design of the device
10 insures safety for those receiving an injection by use of the
device 10 because they can be sure that only a new and never before
used device is used to give them the injection. Further, the device
10 provides for long-term storage of the device and its pre-filled
medication, so that devices 10 may be stockpiled in anticipation of
such events as mass inoculations. The device 10 may be used under
exigent circumstances as well, since it requires only a few seconds
or less to convert it from its "storage" configuration to its
"inject" configuration, after which the jet injection is
immediately effected.
FIG. 6 provides a fragmentary view of an alternative embodiment of
the jet injection device according to this invention. In FIG. 6,
only the aft or trigger assembly end of the device is illustrated.
The forward end of the device and its pre-filled medication
injection cartridge may be substantially as depicted and described
above. Because the device illustrated in FIGS. 6-8 has many
features that are the same as, or which are analogous in structure
or function to those illustrated and described above, these
features are indicated on FIGS. 6-8 using the same reference
numeral used above, and increased by one-hundred (100).
Viewing FIGS. 6-8 in conjunction with one another, it is seen that
the injection device 110 includes a body portion 112c, which is
necked to a slightly smaller diameter aft portion at 214. This aft
portion defines a plurality of circumferential barbs 214a, and an
end cap 202 is received on these barbs and is permanently engaged
there by a matching set of inwardly extending barbs 202a. Slidably
received in this body portion 112c is a one-piece molded
hammer-and-sear member 184.
Preferably, this member 184 is molded of plastic polymer. The
hammer-and-sear member 184 is seen in perspective in FIGS. 7 and 8.
It is seen that this hammer-and-sear member 184 includes a
cylindrical and tubular skirt section 216 defining a spring recess
216a, into which the spring 192 is captively received and preloaded
to make the device 110 ready for use. A center wall portion 218 of
the member 184 provides a surface 218a, which is engageable with
the gas capsule 182 to move this capsule forward, and to impale the
capsule on the penetrator spike (not seen in FIG. 6, but recalling
FIGS. 3-5 above). In order to hold the hammer-and-sear member
against the pre-load of spring 192, and to resist the pressure of
this spring over a long term the member 184 includes three axially
extending legs 220.
Each of these legs 220 is a portion of a cone-shaped section 220a,
best seen in FIGS. 7 and 8. The transition between the circular
cylindrical section 216, and the cone-shaped section 220a is
indicated with a dashed line circumscribing the member 184 in FIG.
7. Forwardly of this transition, the legs 220 flare out by their
own resilience. As is seen in FIG. 6, these legs 220, at an end
surface 220b of each one engage upon a ring-like abutment member or
rear ring member 222 carried within the body portion 112c. As is
best appreciated by consideration of FIG. 7, it is seen that the
end surfaces 220b of the legs 220 are not formed on the radius of
the cone-shape at this end of the member 184 (i.e., at the cone
diameter having a center line indicated as "CL" on FIG. 7), but are
formed at a smaller radius corresponding generally with the
circular diameter of the section 216 (indicated by the radius lines
and character "R" of FIG. 7). During storage of the device 110,
these end surfaces 220b rest upon the abutment member 222 and
transfer the spring force from spring 192 to this abutment member
on a long-term basis.
In order to prevent creep of the plastic polymer material from
which the member 184 is formed, the surfaces 220b define
cooperatively, a contact area which corresponds substantially to
that of the diameter 216 of the member 184 multiplied by the radial
thickness of the legs 220. This contact surface area is sufficient
to prevent creeping of the polymer from which the member 184 is
formed.
In order to effect release of the hammer-and-sear member 184 when
it is desired to effect a jet injection with the device 110, the
body portion 112c defines three axially extending slots 200 (only
one of which is seen in FIG. 6), each corresponding to a respective
one of the legs 220. As is seen in FIG. 6, the trigger sleeve 122
carries three trigger blocks 122a (again, only one of which is seen
in FIG. 6) which are slidably received in the slots 200. When this
trigger sleeve 122 is moved forward, the trigger blocks 122a
simultaneously force respective ones of the legs 220 radially
inwardly and out of engagement with the abutment member 222,
overcoming both the inherent resilience of these legs and the
component of spring force resulting from the radial flaring of
these legs. It will be appreciated that in view of this combination
of inherent resilience and outward flare of the legs 220, there is
virtually no risk that the device 110 will trigger except in
response to deliberate forward movement of the trigger sleeve
122.
Because the legs 220 are formed at a circular (rather than conical)
radius, they nest together and are received into the ring-like
abutment member 222. Thus, the spring 192 forces the hammer-and-war
member 184 forcefully forward, effecting a jet injection from
device 110, as was explained above.
While the invention has been depicted and described by reference to
two particularly preferred embodiments of the invention, such
reference does not imply a limitation on the invention, and no such
limitation is to be inferred. The invention is capable of
considerable variation and alteration in its embodiments without
departing from the scope of this invention. Accordingly, the
invention is intended to be limited only by the spirit and scope of
the appended claims, giving cognizance to equivalents in all
respects.
* * * * *