Title of Invention

A DEVICE FOR INJECTING AVISCOUS MEDICAMENT

Abstract The present invention provides a pneumatic injector (10) that includes a pressurized gas source (50), an actuator (100), a driver (150),and a dispenser (200). The dispenser (200) of the injector (10) includes a reservoir (210) for containing a desired amount of a chosen medicament (220) and a needle (250), such as a hypodermic needle, suitable for subcutaneous, intramuscular, or intra-articular delivery of the chosen medicament (220). The actuator (100) actuates the transmission of pressurized gas from the pressurized gas source (50) to the driver (150) and as pressurized gas is delivered to the driver (150), the driver exerts at least an injection force. The injection force is of a sufficient magnitude to expel a chosen medicament through the needle of the dispenser within a desired amount of time. Advantageously, the design of the injector of the present invention is extremely flexible, allowing the injector to be designed to deliver a wide range of medicaments in virtually any human or veterinary context calling for the injection of the subcutaneous, intramuscular, or intra-articular injection of medicament
Full Text This is a non-provisional application claiming priority under 35 U.S.C. § 119 from
United States provisional application 60/337,753, filed on November 9, 2001.
BACKGROUND
Field of the Invention : The present invention relates to a device for injecting a
viscous medicament. In particular, the present invention relates to an injector capable of
delivering medicaments to animal and human subjects and to a method for delivering
medicaments to animal or human subjects.
State of the Art: Automatic injectors (hereinafter referred to "autoinjectors") are
well known in the medical and veterinary industries and enable the automatic injection of
a desired dose of medicament to animal or human subjects. Autoinjectors are generally
designed according to one of two delivery mechanisms : those that deliver medicament
using a needle (hereinafter "needled" autoinjectors); and those that do not (hereinafter
"needle-less" autoinjectors) No matter what their design, autoinjectors are thought to
exhibit several advantages relative to simple hypodermic syringes. For instance,
because autoinjectors may be designed to automatically and reliably deliver a desired
dose of medicament on demand, they facilitate quick, convenient, and accurate delivery
of medicaments. In particular, autoinjectors are well suited for use by human subjects
who must self-administer therapeutic substances. Moreover, where autoinjectors
incorporate a needled injection mechanism, they may be designed so that the needle is
hidden from view before, during, and after a delivery cycle, thereby
reducing or eliminating any anxiety associated with the act of penetrating
a visible needle into the subject's tissue. Various different injection devices are
disclosed in U.S. Patents 3,797,489, 5,176,645, 5,527,287, 5,300,030, and
6,270,479, U.S. Patent Application 20010005781, and International Publications
WO 94/13342 and WO 95/31235.
[0004] Despite the benefits they provide, however, state of the art
autoinjectors are not generally designed for delivery of viscous medicaments.
Because the medicament delivered by needle-less autoinjectors is typically
accelerated to a very high velocity (e.g., 800 feet per second (fps) to 1,200 fps) to
effect injection, needle-less autoinjectors are not well suited for the delivery of
viscous medicaments or medicaments incorporating particles larger than a few
microns in any dimension. Moreover, autoinjectors including needled injection
mechanisms are generally designed to deliver aqueous solutions having very low
viscosities, such as insulin or epinephrine solutions, and, therefore, do not
typically address the performance hurdles presented when seeking to deliver
viscous medicament via a needled injection mechanism.
[0005] Generating an injection force of sufficient magnitude to drive a viscous
medicament through a needle of suitable gauge within a suitable amount of time is
one performance hurdle that must be overcome in order to deliver a viscous
medicament via a needled injection device. To ensure the safety and comfort of
the subject, the gauge of the needles used in needled injection devices typically
ranges from about 21 gauge to about 31 gauge. Yet, a number of existing and
emerging medicaments designed for delivery via subcutaneous, intramuscular, or
intra-articular injection exhibit viscosities that range up to and above 10 Poise,
100 Poise, 1,000 Poise, and even 10,000 Poise. As is easily appreciated by
reference to the Hagen-Poiseuille Law, F = 8QµL(R2/r4), wherein "F" represents
the injection force required, "Q" represents the flow rate of the material injected,
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"µ" represents the viscosity of the material injected, "L" represents the length of
the needle used, "R" represents the internal diameter of the reservoir containing
the material to be injected, and "r" represents the internal diameter of the needle
used, injection of such medicaments through a needle of suitable gauge may
require an injection force that approaches or exceeds 100 pounds. For example,
the Hagen-Poiseuille Law indicates that in order to deliver 0.5 cc of a medicament
having a viscosity of 200 Poise within 10 seconds via a syringe having an internal
diameter of 4.5 mm and a 0.5 inch needle having an internal diameter of 0.012
inches (a 24 gauge needle), an injection force of approximately 100 pounds would
be required. However, the injection mechanisms provided in currently available
needled autoinjectors are generally not designed to generate such high injection
forces.
[0006] Subject discomfort is a second hurdle facing the design of a needled
autoinjector capable of delivering viscous medicaments. For instance, the sudden
application of a force suitable for delivering a viscous medicament via a needle of
suitable gauge may startle the subject, particularly if the application of such force
causes the transmission of noticeable recoil or impact forces. Thus, an injector
capable of delivering viscous medicaments would ideally incorporate a driver that
operates without producing sudden, potentially distressing noises or transmitting
significant recoil or impact forces to the subject. In addition, driving a needle into
the subject with the same force required to drive a viscous medicament through a
needle of desired gauge may cause the subject unnecessary physical discomfort.
For instance, where the gauge of the needle ranges from about 21 to 31 gauge, an
insertion force ranging from about 1 to 7 pounds is believed to be most
comfortable. Some studies even suggest that human subjects experience the least
amount of pain when the needle is inserted with the least amount of force
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necessary. Therefore, in order to minimize or reduce the discomfort of the
intended subject, an injector capable of injecting viscous medicaments should not
only operate unobtrusively, but, where desired, the injector should be capable of
inserting a needle with an insertion force tailored to minimize subject discomfort.
Ideally, such an injector would generate both an insertion force and an injection
force sufficient to deliver a viscous medicament through a needle of desired gauge
within a suitable amount of time using a single driving mechanism.
SUMMARY OF THE INVENTION
(0007] The present invention provides a needled injector that may be used to
deliver medicaments exhibiting a wide range of viscosities to human or animal
subjects. In the context of the present invention, the term "viscosity" refers to the
resistance of a material to sheer forces as measured at a 1.0 sec-1 shear rate and
25°C using a Haake Rheometer, the term "viscous" is used to define medicaments
having a viscosity of about 1 Poise or greater as measured at a 1.0 sec-1 shear rate
and 25°C using a Haake Rheometer, and the term "medicament" is used to define
any beneficial agent that may be administered by injection to either a human or
animal subject. For example, medicaments that may be delivered using the
injector of the present invention include liquids, suspensions, gels, solutions,
slurries, and pastes containing any physiologically or pharmacologically active
substance, or any other substance that may be of value in treating or caring for
human or animal subjects.
[0008] In each of its embodiments, the injector of the present invention may
be designed to generate an injection force of sufficient magnitude to deliver a
viscous medicament through a needle of suitable gauge within a chosen amount of
time. Where desired, the injector of the present invention may be designed to
drive the needle of the injector into the tissue of the subject with an insertion force
that is tailored to minimize subject discomfort. Advantageously, the operation of
the injector of the present invention is simple, quiet, and does not result in the
transmission of noticeable recoil or impact forces. In addition, the design of the
injector is extremely flexible, allowing the injector for use in virtually any context
calling for the subcutaneous, intramuscular, or intra-articular injection of a
medicament. Therefore, not only can an injector of the present invention be
designed to deliver a wide range of medicaments, even viscous medicaments, but
the injector of the present invention operates unobtrusively, thereby serving to
minimize any anxiety experienced by the subject.
[0009] The present invention also includes a method of injecting medicament.
In each of its embodiments, the method of the present invention includes
providing a desired medicament, providing a needle of a desired gauge, inserting
the needle into the tissue of the subject, and generating an injection force
sufficient to drive the medicament through the needle and into the tissue of the
subject. Though the medicament provided in the method of the present invention
may exhibit any viscosity, the method of the present invention preferably includes
providing a viscous medicament. The gauge and length of the needle provided
and used in the method of the present invention will depend upon, for example,
the medicament delivered, the proposed subject, and whether the injection is
subcutaneous, intramuscular, or intra-articular. Nevertheless, the gauge and length
of the needle are preferably chosen to minimize subject discomfort. Further, the
injection force generated in the method of the present invention must be sufficient
to deliver a desired dose of the provided medicament within a suitable amount of
time. Preferably, the injection force generated in the method of the present
invention is sufficient delivering a desired dose of a chose medicament within, 10
seconds, and even more preferably within 5 seconds. The exact magnitude of the
injection force generated in the method of the present invention, however,
depends on various factors, such as the medicament chosen, the length an gauge
of the needle chosen and the desired delivery time. The method of the present
invention may further include providing an insertion force, which is less than the
injection force. The insertion force may be tailored to minimize subject
discomfort as the needle is inserted into the tissue of the subject. For example,
where the intended subject is human and the gauge of the needle provided ranges
from between 21 gauge and 31 gauge, an insertion force of between about 1
pound and 7 pounds is preferred, with an injection force of between about 1 and 4
pounds being even more preferable. However, where the method of the present
invention involves providing an insertion force, the magnitude of the insertion
force will vary according to several factors, such as the anticipated subject, the
gauge of the needle used to deliver the medicament, and whether the injection is
to be subcutaneous, intramuscular, or intra-articular.
BRIEF DESCRIPTION OF THE ACCOMPANYING RAWINGS
[0010] FIG. 1 illustrates an injector according to the present invention
including a multistage driver and an actuator including a valve mechanism.
FIG. 2 illustrates a sealed microcylinder.
FIG. 3 illustrates a break-away microcylinder.
FIG. 4 illustrates an injector according to the present invention including a single
stage driver and an actuator including a piercing mechanism.
FIG. 5 illustrates an injector according to the present invention including a
multistage driver and an actuator including a plunger mechanism.
6
FIG. 6 illustrates an injector according to the present invention including a
multistage driver and an actuator including a plunger mechanism.
FIG. 7 and FIG. 8 illustrate caps that may be used in an injector of the present
invention, the caps incorporating a plunger mechanism.
FIG. 9 illustrates an injector according to the present invention that incorporates a
restrictor.
FIG. 10a illustrates an injector according to the present invention that incorporates
a pressure regulator.
FIG. 10b illustrates an injector according to the present invention that incorporates
a pressure regulator and a restrictor.
FIG. 11 through FIG. 13 illustrate the pressure regulator provided in the injectors
illustrated in FIG. 10a and 10b.
FIG. 14 and FIG. 15 illustrate a syringe cartridge that may be used as a dispenser
for an injector of the present invention.
FIG. 16 through FIG. 22 illustrate a collapsible syringe cartridge that may be used
as a dispenser for an injector of the present invention.
FIG. 23 illustrates an injector of the present invention that includes an integrated
driver and dispenser including a multistage piston.
FIG. 24 illustrates an injector of the present invention that includes an integrated
driver and dispenser including a single stage piston.
FIG. 25 provides a graph illustrating that the forces exerted by the injector of the
present invention may be increased or decreased by increasing or decreasing the
pressure generated within the pneumatic cylinder of the driver or by increasing or
decreasing the surface area of the piston included within the driver.
FIG. 26 through FIG. 29 illustrate one embodiment of the method of the present
invention.
TABLE 1 presents the results of two tests conducted to determine the injection
time required by an injector of the present invention to deliver a desired dose of an
exemplary material.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
[0011] The injector 10 of the present invention includes a pressurized gas
source 50, an actuator 100, a driver 150, and a dispenser 200. The dispenser 200
of the injector 10 includes a reservoir 210 for containing a desired amount of a
chosen medicament 220 and a needle 250, such as a hypodermic needle, suitable
for subcutaneous, intramuscular, or intra-arricular delivery of the chosen
medicament 220. The actuator 100 actuates the transmission of pressurized gas
from the pressurized gas source 50 to the driver 150, and as pressurized gas is
delivered to the driver 150, the driver 150 exerts at least an injection force. The
injection force is of sufficient magnitude to expel the medicament 220 through the
needle 250 of the dispenser 200 within a desired amount of time.
Advantageously, the design of the injector 10 of the present invention is extremely
flexible, allowing the injector 10 to be designed to deliver a wide range of
medicaments in virtually any human or veterinary context calling for the injection
of the subcutaneous, intramuscular, or intra-arricular injection of medicament.
An exemplary injector 10 according to the present invention is illustrated in FIG.
1.
[0012] Though any suitable source of pressurized gas may be used as the
pressurized gas source 50 of the injector 10 of the present invention, it is presently
preferred that the pressurized gas source 50 includes a microcylinder 52 of
compressed gas. Microcylinders are economical, compact, and capable of storing
varying amounts of gas at high pressures. For example, commercially available
microcylinders can be reliably and inexpensively filled with about 1 gram to about
30 grams of a suitable gas, such as carbon dioxide, helium, hydrogen, oxygen,
nitrogen, or air, at pressures ranging between about 200 pounds per square inch
("psi") to about 3,000 psi and above. Moreover, microcylinders having such
capabilities can be extremely compact, having a length of one inch or less and a
diameter of one-half inch or less. Therefore, a microcylinder 52 of pressurized
gas provides a powerful, economical source of pressurized gas that allows the
fabrication of an injector that is highly portable 10 and easy to use.
[0013] Where a microcylinder is utilized in conjunction with the injector of
the present invention, two general microcylinder designs are presently preferred.
The first general design 54 (hereinafter referred to as a "sealed microcylinder") is
illustrated in FIG. 2, and is exemplified by microcylinders having a cylinder body
56 and a seal 58. Such microcylinders are available from Leland Limited, Inc., of
South Plainfield, New Jersey. In order to release compressed gas maintained
within a sealed microcylinder, the seal 58 must be compromised (e.g., broken,
pierced, or otherwise penetrated). The second general microcylinder design 60
(hereinafter referred to as "break-away microcylinders") is shown in FIG. 3 and is
exemplified by microcylinders that include an elongated neck 62 extending away
from a cylinder body 56, the elongated neck 62 being designed to break away
upon application of a predetermined force. Such microcylinders are described in
U.S. Patent 6,047,865 and U.S. Patent 5,845,811 and are manufactured by BOC
Limited of London, U.K. As is easily appreciated, compressed gas stored within a
break-away microcylinder is released when the elongated neck 62 of the
microcylinder is broken. Though each of the embodiments illustrated and
discussed herein utilize either a sealed microcylinder or a breakaway
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microcylinder, the injector 10 of the present invention may be designed to utilize a
microcylinder 52 of any suitable design.
(0014] Where a microcylinder 52 is used as the pressurized gas source 50 of
the injector 10 of the present invention, the microcylinder 52 is preferably
disposed within a cap 64. A cap 64 effectively increases the dimensions of the
microcylinder 52 and thereby eases manipulation of the microcylinder 52 when
the microcylinder 52 is not mounted to the body 12 of the injector 10. Where
provided, a cap 64 is configured to receive a microcylinder 52 of desired
configuration and may be designed to maintain the microcylinder 52 within the
cap 64 via any suitable means. For instance, the caps 64 illustrated in FIG. 1,
FIG. 4 through FIG. 10, and FIG. 25 and FIG. 26 are sized and shaped such that
the microcylinders 52 disposed therein are maintained within the caps 64 by a
friction fit created by the interface of the microcylinders 52 with the inner walls
66 of the caps 64. Though the caps 64 illustrated in FIG. 1, FIG. 4 through FIG.
10, and FIG. 25 and FIG. 26 are designed to receive and maintain sealed
microcylinders or breakaway microcylinders, a cap 64 used in an injector 10
according to the present invention may be designed to receive and maintain a
microcylinder 52 of any suitable design.
[0015] A cap 64 may also facilitate mounting of the microcylinder 52 to the
body 12 of the injector 10 of the present invention. For example, the cap 64 may
be configured to allow mounting of the cap 64 to the body 12 of the injector 10
using any bonding or adhesive process providing secure attachment of the cap 64
to the body 12 of the injector 10. Alternatively, the cap 64 may include a first
portion of a fastening mechanism that is complimentary to a second portion of a
fastening mechanism provided on the body 12 of the injector 10. For instance, the
cap 64 may be provided with a first threaded area that is compatible with a second
threaded area formed on the body 12 of the injector 10. Alternatively, the cap 64
may include a first portion of a snap-fit connector complimentary to a second
portion of a snap fit connector provided on the body 12 of the injector 10. Further
examples of fastening mechanisms that may be incorporated in a cap 64 and the
body 12 of the injector 10 to facilitate mounting of the microcylinder 52 to the
injector 10 are toggle assemblies and male/female connectors. However, it is to
be understood that the cap 64 may incorporate any fastening mechanism capable
of securely fastening the cap 64 to the body 12 of the injector 10.
[0016] In order to minimize the unwanted escape of pressurized gas from the
injector 10 of the present invention, one or more sealing members 18 may be
provided where the cap 64 or microcylinder 52 interface with the body 12 of the
injector 10. Such sealing members 18 may include O-rings or any other suitable
sealing device capable of reducing or eliminating the escape of pressurized gas.
The injector 10 illustrated in FIG. 1 includes a sealing member 18 positioned such
that, as the microcylinder 52 is mounted to the body 12 of the injector, a seal is
formed between the body 12 of the injector 10 and the microcylinder 52 before the
seal 58 of the microcylinder 52 is compromised. FIG. 5 and FIG. 6 illustrate
injectors 10 of the present invention including a sealing member 18 positioned
between the cap 64 and the body 12 of the injectors 10. The sealing member 18 is
positioned within a seat 70 formed within the cap 64 and creates a seal that
reduces or eliminates the escape of pressurized gas from the injector 10. Though
the various figures providing illustrations of injectors of the present invention
illustrate sealing members 18 at particular positions between the microcylinder 52,
the cap 64, and the body 12 of the injector 10, the placement of sealing members
18 is not limited to the exact positions illustrated.
[0017] The actuator 100 of the injector 10 of the present invention may
include any suitable mechanism capable of actuating the flow of pressurized gas
from the pressurized gas source 50 to the driver 150 of the injector 10. For
instance, where the injector 10 of the present invention includes a microcylinder
52 of compressed gas, the actuator 100 may include or trigger, piercing
mechanism, plunger, or other force transfer mechanism that, upon actuation,
compromises the microcylinder 52 (e.g., pierces, breaks, or penetrates the seal 58
or breaks away the elongated neck 62 of the microcylinder 52) and allows
pressurized gas to escape to the driver 150 of the injector 10. Alternatively, where
the design of the injector 10 does not require that the actuator 100 compromises
the pressurized gas source 50, the actuator 100 may include a valve for actuating
the flow of pressurized gas from the pressurized gas source 50 to the driver 150.
In order to prevent accidental activation, or "firing," of the injector 10, the
actuator 100 may also be linked to or protected by a safety mechanism that serves
to prevent triggering of the actuator 100 until a deliberate act is executed in
preparation for use of the injector 10.
[0018] FIG. 1 illustrates an injector 10 according to the present invention that
includes an actuator 100 comprising a valve assembly 102 that allows the user to
actuate flow of compressed gas from the pressurized gas source 50, through a first
fluid path 16, and to the driver 150 of the injector 10. The valve assembly 102
includes a valve seat 104, a valve body 106, a button 108, and a biasing element
110, which may include a spring, a rubber bumper, a polymer bumper, or any
other suitable resilient member. The biasing element 110 is placed within the
valve seat 104 and acts against the valve body 106 to maintain valve body 106 in a
normally closed position. In the closed position, the valve body 106 obstructs the
first fluid path 16 and prevents gas flow to the driver 150. However, when
sufficient pressure is exerted on the button 108, the valve body 104 is moved
against the biasing member 110 into an open position (shown in FIG. 1). As the
valve body 106 is placed in an open position, a depression 112 formed in the valve
body 106 forms a second fluid path 114, which allows pressurized gas to flow
from the first fluid path 16 to the driver 150. The valve body 106 may also
include one or more sealing members 18, such as one or more O-rings. The
sealing members 18 work to minimize any escape of pressurized gas from the
valve assembly 102, particularly when the valve body 106 is placed in an open
state.
[0019] As can be appreciated by reference to FIG. 1, where an injector 10
according to the present invention includes an actuator 100 comprising a valve
assembly 102, the injector 10 may be provided with a mechanism designed to
compromise the pressurized gas source 50 as it is mounted to the injector 10. The
mechanism illustrated in FIG. 1 includes a hollow pierce pin 14, which defines a
first fluid path 16 and penetrates the seal 58 of the microcylinder 52 as the cap 64
containing the microcylinder 52 is threaded onto the body 12 of the injector 10. In
order to minimize the undesired escape of pressurized gas from the system, a
sealing member 18, such as an O-ring, may be positioned between the
microcylinder 52 and the body 12 of the injector 10 (shown in FIG. 1) or between
the cap 64 and the body 12 of the injector 10. As the microcylinder 52 is secured
to the injector 10, the sealing member 18 forms a seal between the microcylinder
52 and the body 12 of the injector 10 before the hollow pierce pin 14 has
completely breached the seal 58 of the microcylinder 52. Once, the microcylinder
52 is secured to the injector 10 and the seal 58 of the microcylinder 52 is
compromised, the flow of pressurized gas from the microcylinder 52 to the driver
150 is simply actuated through actuation of the valve assembly 102 of the actuator
100.
[0020] Instead of a valve assembly, the actuator 100 may simply include a
piercing assembly, as is shown FIG. 4. Pressurized gas flow between the
pressurized gas source 50 and the driver 150 of the injector 10 shown in FIG. 4 is
actuated simply by mounting a cap 64 containing a microcylinder 52 to the body
12 of the injector. As the cap 64 containing the microcylinder 52 is mounted to
the injector 10, a hollow pierce pin 14 compromises the seal 58 of the
microcylinder 52 and pressurized gas is delivered to the driver 150 from the
microcylinder 52 through the first fluid path 16.
[0021] Where a breakaway microcylinder 52 is used as the pressurized gas
source 50 of an injector 10 according to the present invention, the actuator 100 of
the injector 10 may include a plunger assembly 124, as shown in FIG. 6. The
plunger assembly 124 may be incorporated into the body of the injector (not
shown), or the plunger assembly 124 may be incorporated into a cap 64 containing
the microcylinder 52 (shown in FIG. 6). Regardless of where it is provided, the
plunger assembly 124 includes a passageway 126 within which the plunger 128 is
disposed. The plunger assembly 124 may further include one or more sealing
members 18, which form a seal between the plunger 128 and the passageway 126
and minimize the undesired escape of pressurized gas through the plunger
assembly 124 during use of the injector 10. Theplunger 128 may be moved back
and forth within the passageway 126 and may be maintained within the
passageway 126 of the actuator plunger mechanism 124 simply through a friction-
fit or any other suitable means. Whether it is included in the body 12 of the
injector 10 or a cap 64 containing the microcylinder 52, the plunger assembly 124
is positioned such that the depression of the plunger 128 with sufficient force will
break away the elongated neck 62 of the microcylinder 52. Though the plunger
128 of the plunger assembly 124 illustrated in FIG. 6 is positioned generally
perpendicularly to the longitudinal axis of the microcylinder 52 contained within
the cap 64, such a configuration is not required, as shown in FIG. 7 and FIG. 8.
[0022] The injector illustrated in FIG. 6 includes a safety mechanism 20,
which serves to minimize accidental activation of the injector 10. The safety
mechanism 20 includes a first portion 22, a second portion 24, and a spring 26.
The first portion 22 is generally cylindrical in shape and includes a stop 32 and a
slot 30 terminating in a port 31. The second portion 24 of the safety mechanism
20 is also generally cylindrical in shape. At its distal end 34, the second portion
24 includes a lip 36 sized to allow the passage of the adjustable tip 230 of the
dispenser 200, but the lip 36 also serves as a mechanical stop, preventing the
passage of the body 12 of the injector 10 through the distal end 34 of the second
portion 24. The spring 26 is positioned within a seat 38 formed in the body 12 of
the injector 10, and after the spring 26 is positioned within the seat 38, the first
and second portions 22, 24 of the safety mechanism 20 are fastened together by
any suitable means. For example, the first and second portions 22, 24 may be
bonded, welded, glued, threaded, or snap-fit together. The spring 26 acts against
the distal end 40 of the first portion 22 to bias the safety mechanism in a "safe"
position. In the safe position, the stop 32 included on the first portion 22 prevents
actuation of the actuator 100 included in the injector 10.
[0023] The safety mechanism is moved out of the safe position illustrated in
FIG. 6 by sliding the first and second portions 22, 24 against the spring 26 such
that the stop 32 no longer interferes with the actuator 100. This may be
accomplished by positioning the injector 10 generally perpendicularly against the
tissue of a subject and applying a downward force sufficient to overcome the bias
force exerted by the spring 26 of the safety mechanism 20. In the example shown
in FIG. 7, the neck 129 of the plunger 128 passes through the slot 30 as the first
and second portions 22, 24 are slid against the spring 26. Preferably, however, the
slot 30 is sized to prevent the body 130 of the plunger 128 from being expelled
from the passageway 126 as pressurized gas is released from the microcylinder
52.
[0024] The driver 150 of the present invention may be designed as a single
stage driver 152 or a multistage driver 154. FIG. 4 and FIG. 24 illustrate injectors
10 according to the present invention including a single stage driver 152, while
FIG. 1, FIG. 5, FIG. 6, FIG. 9, FIG. 10, and FIG. 23 illustrate injectors 10
according to the present invention including a multistage driver 154.
[0025] Where the driver 150 of the present invention is a single stage driver
152, the single stage driver 152 includes a single stage piston 156 disposed within
a pneumatic cylinder 158 having at least one chamber 160. The single stage
piston 156 provided in the single stage driver 152 includes a injection stage 162
and may include a sealing member, such as an O-ring or cup seal (not shown in
FIG. 4), that forms a seal between the injection stage 162 and the wall 164 of the
chamber 160 of the pneumatic cylinder 158. The single stage piston 156
optionally includes a plunger 166, which extends out and away from the injection
stage 162 and is positioned to act against the dispenser 200 as the single stage
piston 156 is driven through its stroke within the pneumatic cylinder 158.
[0026] As pressurized gas enters the pneumatic cylinder 158 of a single stage
driver 152, the pressurized gas acts against the injection stage 162 and drives the
single stage piston 156 through its stroke with an injection force. The magnitude
of the injection force exerted by the single stage piston 156 is equal to the surface
area of the injection stage 162 multiplied by the pressure created within the
chamber 160 of the pneumatic cylinder 158 (Force = Pressure x Area). Therefore,
where a given pressure or pressure profile is produced within the chamber 160 of
the pneumatic cylinder 158, the magnitude of the injection force exerted by the
single stage piston 156 may be adjusted, as desired, by increasing or decreasing
the surface area of the injection stage 162. The injection stage 162 of the single
stage piston 154 is sized to ensure that the single stage piston 156 exerts an
injection force sufficient to deliver a desired dose of a chosen medicament within
a desired amount of time.
[0027] A multistage driver 154 included in an injector 10 according to the
present invention includes a pneumatic cylinder 158 having at least two chambers
167, 168 and a multistage piston 170 having at least an insertion stage 172 and an
injection stage 162. The insertion stage 172 of the multistage piston 170 is
characterized by a first surface area and may include a first sealing member 174,
such as an O-Ring. Alternatively, the first sealing member 174 may be provided
in a seat 176 created within the wall 178 of the first chamber 167. The injection
stage 162 of the multistage piston 170 is characterized by a second surface area,
which is larger than the first surface area of the insertion stage 172. The injection
stage 162 may include a second sealing member 180, such as an O-ring or cup
seal, which creates a seal between the wall 182 of the second chamber 168 and the
injection stage 162 as the multistage piston 170 is driven through its stroke. The
multistage piston 170 may also a plunger 166 that extends out and away from the
injection stage 162 and is positioned to act against the dispenser 200 of the
injector 10. The pneumatic cylinder 158 and the multistage piston 170 are
designed such that pressurized gas entering the pneumatic cylinder 158 acts
against the insertion stage 172 and the injection stage 162 sequentially, thereby
causing the multistage piston 170 to sequentially exert at least an insertion force
and an injection force.
[0028] Pressurized gas entering a multistage driver 154 included in an injector
of the present invention acts sequentially against each stage. For example,
pressurized gas entering the multistage driver 154 illustrated in FIG. 1, FIG. 5,
FIG. 6, FIG. 9, FIG. 10, FIG. 23 acts first against the insertion stage 172 and
second against the injection stage 162 of the multistage piston 170. As
pressurized gas acts against the insertion stage 172, the multistage piston 170
exerts an insertion force. The magnitude of the insertion force is equal to the
pressure produced within the first chamber 167 of the pneumatic cylinder 158
multiplied by the surface area of the insertion stage 172 (Force = Pressure x Area).
Therefore, where a given pressure or pressure profile is produced within the first
chamber 167, the insertion force exerted by the multistage piston 170 may be
increased or decreased as desired simply by increasing or decreasing the surface
area of the insertion stage 172. Advantageously, the insertion stage 172 of a
multistage piston 170 may be sized such that the multistage piston 170 exerts an
insertion force that minimizes subject discomfort.
[0029] Once the insertion stage 172 of the multistage piston 170 is driven
through a predetermined stroke, pressurized gas enters the second chamber 168 of
the pneumatic cylinder 158 and acts against the injection stage 162, causing the
multistage piston 170 to exert an injection force. The injection force exerted by
the multistage piston 170 is equal to the pressure generated within the second
chamber 168 multiplied by the surface area of the injection stage 162. Therefore,
where a given pressure or pressure profile is produced within the second chamber
168, the magnitude of the injection force exerted by the multistage piston 170 may
be increased or decreased, as desired, by increasing or decreasing the surface area
of the injection stage 162. Again, the injection stage 162 is sized to ensure the
production of an injection force sufficient to deliver a desired dose of a chosen
medicament within a desired amount of time.
[0030] Achieving a desired pressure or pressure profile within the driver of an
injector of the present invention may be accomplished by altering one or more of
several design variables. For example, if the injector of the present invention does
not include a pressure regulator or a restrictor, the pressure produced within driver
will depend on the pressure and volume of compressed gas contained within the
pressurized gas source, the volume of the pneumatic cylinder, and the stroke of
the piston included in the pneumatic cylinder. If the injector includes a restrictor,
the pressure generated within the driver will depend upon the pressure and volume
of compressed gas contained within the pressurized gas source, the maximum rate
of gas flow permitted by the restrictor, and the rate at which the medicament flows
from the dispenser once a suitable injection force is generated. Finally, where the
injector of the present invention includes a pressure regulator, the pressure
generated within the driver can be controlled independently of the volume of the
pneumatic cylinder, the stroke of the piston, or the rate at which medicament
flows from the dispenser. Therefore, to create a desired pressure, series of
pressures, or pressure profile within the driver of the injector of the present
invention, any one of several components can be adjusted or added.
[0031] FIG. 1, FIG. 2, FIG. 5, FIG. 6, FIG. 23, and FIG. 24 illustrate injectors
10 according to the present invention that do not include either a restrictor or a
pressure regulator. The pressure generated within the pneumatic cylinder 158 of
the driver 150 of such injectors 10 can be accurately predicted and adjusted using
the Ideal Gas Law, P1 V1 = P2V2. If the volume and pressure of the pressurized
gas source 50 are taken to be P1 and V1, respectively, and the volume of the
pneumatic cylinder 158 is taken to be V2, then the pressure (P2) generated within
the pneumatic cylinder equals 158 the product of P1 and V1 divided by V2.
Therefore, the pressure generated within the pneumatic cylinder 158, is directly
proportional to volume and pressure of the gas contained within the pressurized
gas source 50 and inversely proportional to the volume of the pneumatic cylinder
158. Using this relationship, the pressure generated within the pneumatic
cylinder 158 of an injector 10 lacking both a restrictor and a pressure regulator can
be adjusted to a desired magnitude simply by modifying the pressure of the gas
contained within the pressurized gas source 50 or by modifying the volume of
either the pressurized gas source 50 or the pneumatic cylinder 158.
[0032] As can be easily appreciated, where the injector 10 of the present
invention does not include either a restrictor or a pressure regulator, the pressure
produced in the one or more chambers 160, 167, 168 of the pneumatic cylinder
158 will decrease at least slightly as the piston 156,170 moves through its stroke.
This is because the pressure (P2) generated within pneumatic cylinder 158 is
inversely proportional to the volume (V2) filled by the pressurized gas, and as the
piston 156, 170 moves through its stroke the volume (V2) filled by pressurized gas
necessarily increases. However, the extent to which the pressure (P2) decreases
within the one or more chambers 160,167,168 of the pneumatic cylinder 158 can
be at least partially controlled by varying the pressure (P1) and volume (V1) of gas
contained in the pressurized gas source 50 or by increasing or decreasing the
stroke of the piston 156,170, which will increase or decrease the change in
volume (V2) as the piston 156, 170 is driven through the pneumatic cylinder 158.
For example, for a pneumatic cylinder 158 of a given volume, the drop in pressure
will be attenuated as the volume or pressure of gas delivered by the pressurized
gas source 50 increases. Conversely, the drop in pressure within a pneumatic
cylinder 158 of a given volume will be accentuated as the pressure or volume of
gas delivered by the pressurized gas source 50 is decreased. Therefore, even
where the injector 10 of the present invention does not include a restrictor or a
pressure regulator, the range of insertion or injection forces produced by the driver
150 of the injector 10 may be controlled by controlling the volume of the
pneumatic cylinder 158, the dimensions of each stage 162, 172 of the piston 156,
170, and the volume and pressure of pressurized gas stored within the pressurized
gas source 52.
[0033] If greater control of the pressure produced within the driver 150 is
desired, the injector 10 of the present invention may be provided with a restrictor
300 or a pressure regulator 400. FIG. 9 illustrates an injector 10 according to the
present invention including a restrictor 300, while FIG. 10 illustrates an injector
10 according to the present invention, which include a pressure regulator 400. By
providing the injector 10 of the present invention with a restrictor 300 or a
pressure regulator 400, a substantially constant gas pressure can be produced
within the pneumatic cylinder 158 of the driver 150, thereby producing
substantially constant insertion or injection forces.
[0034] As can be appreciated by reference to FIG. 9, where a restrictor 300 is
included in the injector 10 of the present invention, the restrictor 300 may simply
include a plate 302 having an orifice 304 sized as desired to limit gas flow to a
targeted maximum rate. The flow rate allowed by such a restrictor 300 is easily
increased or decreased by increasing or decreasing the size of the orifice 304
included in the plate 302. Alternatively, the injector 10 may include an adjustable
restrictor (not shown) that allows the user to select a desired rate of gas flow
within a given range. For instance, an adjustable restrictor may include a screw
mechanism that is advanced or retracted as desired within a fluid passageway. As
the screw mechanism is advanced within the fluid passageway, the fluid
passageway is contracted and allows a relatively smaller maximum gas flow. As
the screw mechanism is retracted, however, the fluid passageway is expanded,
allowing a relatively larger maximum gas flow. Though the restrictor 300 shown
in FIG. 9 is positioned between the actuator 100 and the pressurized gas source 50
of the injector 10, a restrictor 300 included in an injector 10 of the present
invention can be positioned in any other suitable location, such as between the
actuator 100 and the pneumatic cylinder 158 of the driver 150.
[0035] By adjusting the maximum gas flow allowed by the restrictor 300, the
injector 10 of the present invention may be designed to provide a substantially
constant injection force. In order to achieve a substantially constant injection
force through use of a restrictor 300, the maximum rate of gas flow permitted by
the restrictor 300 is tuned to match the rate at which medicament 220 is expelled
from the dispenser 200 once an injection force is created within the pneumatic
cylinder 158 of the driver 150. If the maximum rate of gas flow allowed by the
restrictor 300 is tuned to match the rate at which the medicament 220 is expelled
from the dispenser 200, the pressure within the pneumatic cylinder 158 will
remain substantially constant as the medicament 220 is delivered to the subject.
Therefore, the injector 10 of the present invention can be designed to exert a
substantially constant injection force simply by providing the injector 10 with a
properly tuned restrictor 300.
[0036] FIG. 1 Oa through FIG. 13 illustrate an exemplary pressure regulator
400, which allows constant insertion and injection forces to be produced
independently of the volume of the pneumatic cylinder 158 included in the driver
150, the stroke of the piston 170, or the rate at which medicament 220 is expelled
from the dispenser 200. The pressure regulator 400 illustrated in these figures
includes a base 402 and a cylindrical protrusion 404 extending out from the base
402. The cylindrical protrusion 404 includes a first seat 406 for a first sealing
element 408, a second seat 410 for a second sealing element 412, and a first fluid
path 414. The first fluid path 414 facilitates flow of compressed gas from the
pressurized gas source 50 to the actuator 100. The base 402 includes third seat
416 for a third sealing element 418 and serves as a platform for a first spring
element 420, a second spring element 422, and a spacer ring 424. The first and
second spring elements 420,422 are positioned over the base 402 and around the
cylindrical protrusion 404, and the spacer ring 424 is positioned over the first and
second springs elements 420, 422. The sealing members 408,412,418 included
in the pressure regulator may include any suitable sealing element, such as a
gasket or an O-ring seal. Though any suitable structure may be used to create a
pressure regulator 400 useful in the injector of the present invention, the pressure
regulator 400 illustrated in FIG. 10a through FIG. 13 provides a compact device
capable of maintaining the pressure within the driver 150 at or below a
predetermined level.
[0037] In use, pressurized gas passes from the pressurized gas source 50,
through the first fluid path 414 of the pressure regulator 400, and to the driver
150. As it flows to the driver 150 and accumulates, the pressurized gas exerts
pressure against the base 402 of the pressure regulator 400. The pressure acting
against the base 402 causes the base 402 to exert a force against the first and
second spring elements 420,422, and as the pressure within the system
approaches a predetermined threshold, the force exerted by the base 402 begins to
compress the first and second spring elements 420,422. This pushes the first seal
408 closer to an aperture 426, thereby restricting flow of pressurized gas from the
pressurized gas source through the aperture 426. If the pressure acting against the
base 402 reaches or exceeds the predetermined threshold, the force exerted by the
base 402 overcomes the first and second spring elements 420,422 and the first
seal 408 of the pressure regulator 402 seals the aperture 426, terminating gas flow
from the pressurized gas source 50. As the pressure decreases below the
predetermined threshold, the force exerted by the base 402 decreases and the first
and second spring elements 420,422 draw the first seal 408 away from the
aperture 426, allowing pressurized gas to flow from the pressurized gas source 50
once again.
[0038J The threshold pressure of the pressure regulator 400 shown in FIG. 10a
through FIG. 13 is easily set to any desired value. The maximum pressure that is
allowed by the pressure regulator 400 is determined by the surface area of the base
402 and the combined bias force exerted by the first and second spring elements
420, 422. For example, a pressure regulator designed to maintain the pressure
within the driver at or below about 100 psi may be designed by providing a base
402 having a diameter of about 0.5 inches and first and second spring elements
420,422 that exert a combined maximum spring force of 20 lbs. As a pressure
within the driver 150 reaches or exceeds about 100 psi, the force exerted by the
base 402 against the first and second spring elements 420,422 will reach or
exceed 20 lbs. (Force = Pressure x Area), causing the first seal 408 to seal the
aperture 426 and terminate gas flow into the driver 150. By increasing or
decreasing either the surface area of the base 402 or the combined bias force
exerted by the first and second spring elements 420,422, a pressure regulator 400
may be designed to maintain virtually any desired maximum pressure within the
driver 150.
(0039] As can be seen in FIG. 10b, the injector 10 of the present invention is
not limited to including only a pressure regulator 400 or only a restrictor 300. If
desirable or necessary, the injector 10 of the present invention may include both a
pressure regulator 400 and a restrictor 300. Further, as is appreciable by reference
to FIG. 10a and FIG. 10b, where the injector 10 of the present invention is
provided with a pressure regulator 400, the pressure regulator 400 may be
contained within a housing 430. Such a housing 430 is designed to received
within the body 12 of the injector 10, and the housing 430 may be mounted to the
body 12 using any suitable means. For example, the housing 430 may include a
first threaded area complimentary to a second threaded area provided on the body
12 of the injector 10. Alternatively, the housing 430 may be mounted to the body
12 using any suitable adhesive or bonding methods. Though the pressure
regulator 400 need not be provided in a housing 430 separate from the body 12 of
the injector 10, providing a housing 430 for the pressure regulator may ease the
manufacture of the body 12 and may simplify the inclusion of a pressure regulator
400 in an injector 10 of the present invention.
[0040] Just as the use of a housing 430 for the pressure regulator 400 may
simplify inclusion of a pressure regulator 400 in the injector 10 of the present
invention, providing an injector 10 of the present invention with a multi-piece
body 12 may ease fabrication of the injector 10. For instance, the body 12 of the
injectors 10 illustrated in FIG. 5 and FIG. 6 is constructed of a proximal portion
40 and a distal portion 42. The proximal and distal portions 40, 42 are joined at
an interface 44, for example, by a threading mechanism, a suitable adhesive,
bonding, or welding process, or any other known means providing secure
attachment. A sealing member 18, such as an O-ring, may be provided at the
interface 44 of the proximal and distal portions 40, 42 in order to reduce or
eliminate the unwanted escape of pressurized gas from the injector 10. Both the
proximal portion 40 and the distal portion 42 are designed with various features
that facilitate the assembly and proper function of the injector 10, and by
manufacturing the proximal and distal portions 40,42 as different pieces, the
design and creation of the various features of each portion may be eased. For
example, if the proximal and distal portions 40, 42 of the body 12 of the injectors
illustrated in FIG. 5 and FIG. 6 were integrated into a one-piece body, the creation
of the seat 176 for the first sealing member 174 would be relatively difficult,
possibly requiring custom tooling and likely increasing the cost of fabricating the
injector 10 of the present invention. However, because the proximal portion 40 of
the injectors 10 illustrated in FIG. 5 and FIG. 6 is manufactured separately from
the distal portion 42, the seat 176 for the first sealing member 174 is easily and
inexpensively created within the proximal portion 40 before the proximal portion
40 and the distal portion 42 are joined to form the body 12 of the injector 10.
Therefore, though it is not required, the body 12 of the injector 10 of the present
invention may be manufactured in multiple components to facilitate the
manufacture or fabrication of the injector 10.
[0041] As is true of the components already discussed, the design of the
dispenser 200 of the injector 10 of the present invention is flexible. The dispenser
200 of the injector 10 need only include a reservoir 210, such as a syringe 211,
suitable to contain a desired viscous medicament 220, a needle 250 of suitable
gauge to deliver the desired medicament 220 to the subject, and a piston 270 to
drive the medicament from the reservoir 210 through the needle 250. Though the
injectors 10 illustrated herein include a dispenser 200 including a piston 270 that
is separate from the single stage or multistage pistons 156, 170 included in the
driver 150 of those injectors 10, the piston 270 of the dispenser 200 may also be
integrated into the plunger 166 of the piston 156, 170 included in the driver 150.
[0042] The gauge of the needle 250 included in the dispenser 200 is generally
chosen to be as small as practical. Although the force and time required to deliver
a given medicament 220 through the needle 250 will generally increase as the
diameter of the needle 250 decreases, subject comfort generally increases as the
diameter of the needle 250 decreases. As a result, particularly where the intended
subject is human, the gauge of the needle 250 included in the dispenser is
preferably ranges from 21 gauge to 31 gauge. Even more preferably, the needle
250 included in the dispenser will have a gauge ranging between 24 gauge and
31 gauge, and most preferably, the needle 250 will have a falling within the range
of 27 gauge to 31 gauge. Though a smaller gauge needle will generally be
preferred over a larger gauge needle, where the difference in gauge would not
significantly alter the comfort of the subject, the larger gauge needle may be
chosen to decrease the injection force or injection time required to deliver a given
medicament. Further, although 21 gauge to 31 gauge needles are presently
preferred, where desired or necessary, the injector of the present invention can be
provided with a needle having a gauge outside that presently preferred range.
[0043] To the extent possible, the inner diameter Dr of the reservoir 210
should be chosen to approximate the gauge of the needle 250. This is because the
injection force required to drive a viscous medicament from the reservoir 210
through the needle 250 increases exponentially as the inner diameter Dr of the
reservoir 210 increases away from the inner diameter Dn of the needle 250. Of
course, the benefits of approximating the inner diameter Dr of the reservoir 210 to
the inner diameter Dn of the needle 250 are balanced against other design factors,
such as the desired size of the dispenser 200 and the volume of medicament 220 to
be delivered.
[0044J The dispenser 200 may also include a bias mechanism 280, whereby
the needle 250 and reservoir 210 of the dispenser 200 are maintained in a retracted
position until an insertion or injection force is communicated to the dispenser 200
from the driver 150. Where the driver 150 of the injector 10 includes a single
stage piston 156, the bias mechanism 280 retains the reservoir 210 and needle 250
in a retracted position until an injection force is exerted against the piston 270 of
the dispenser. However, where the driver 150 of the injector 10 includes a
multistage piston 170, the bias mechanism 280 maintains the needle 250 and
reservoir 210 in a retracted position until an insertion force is exerted against the
piston 270 of the dispenser. Moreover, regardless of whether the injector 10
includes a multistage driver 154 or single stage driver 152, as the pressure created
within the injector 10 dissipates after an injection cycle, the bias mechanism 280
automatically retracts the reservoir 210 and needle 250 within the dispenser 200.
[0045] The bias mechanism 280 may include any suitable device for biasing
the reservoir 210 and needle 250 in a retracted position. For example, the bias
mechanism 280 may include a coil spring 282 supporting the reservoir 210 and
needle 250 within the dispenser 200. Alternatively, the bias mechanism 280 may
include any other suitable biasing member, such as a solid or foamed rubber or
polymer bumper, or a fluid filled, resilient bladder. The spring rate or force
required to compress the bias mechanism 280 may be varied, as desired, provided
that such spring rate or force is at least sufficient to bias the reservoir 210 and
needle 250 in a retracted position.
[0046] Where an injector 10 of the present invention includes a single stage
driver 152 and a bias mechanism 280, the injection force exerted by the single
stage driver 152 and the bias force exerted by the bias mechanism 280 may be
adjusted to provide an effective insertion force of desired magnitude. The
effective insertion force is the force with which the needle 250 extends from the
casing 219 of the dispenser, and where the injector 10 of the present invention
includes a single stage driver 150 and a bias mechanism 280, the effective
insertion force is equal to the injection force generated by the single stage driver
152 minus the bias force exerted by the bias mechanism 280. By adjusting either
the injection force exerted by the single stage driver 152 or the bias force exerted
by the bias mechanism 280, a desired effective insertion force may be achieved.
For instance, where an injection force of 10 lbs. is required, an effective insertion
force of about 1 lbs. to about 7 lbs. may be achieved by providing a bias
mechanism 280 that exerts a bias force of about 9 lbs. to about 3 lbs. Even if
higher injection forces are necessary, an effective insertion force of about 1 lbs. to
about 7 lbs. may be achieved by providing a bias mechanism 280 capable of
exerting a higher bias force. Therefore, even where the injector 10 of the present
invention includes a single stage driver 152, the injector 10 may be designed to
provide an effective insertion force tailored to minimize subject discomfort, while
simultaneously generating an injection force sufficient to deliver a chosen
medicament within a desired amount of time.
[0047J The effective insertion force of an injector 10 including a multistage
driver 154 and a bias mechanism 280 may also be adjusted as desired. Where the
injector 10 of the present invention includes a multistage driver 154 and a bias
mechanism 280, the effective insertion force is equal to the insertion force exerted
by the multistage driver 154 minus the bias force exerted by the bias mechanism
280. Consequently, the effective insertion force provided by an injector 10
including a multistage driver 154 and a bias mechanism 280 is easily adjusted by
altering either the insertion force exerted by the multistage driver 154 or the bias
force exerted by the bias mechanism 280. For example, where the bias
mechanism 280 exerts a bias force of about 1 lbs. and an effective insertion force
of about 1 lbs. to 7 lbs. is desired, the pressurized gas source 50 and the multistage
driver 154 of the injector 10 may be designed to exert an insertion force of about 2
lbs. to 8 lbs. Alternatively, if the pressurized gas source 50 and multistage driver
154 of the injector 10 are designed to exert an insertion force of about 5 lbs. and
an effective insertion force of about 1 lbs. to about 4 lbs. is desired, the dispenser
200 of the injector 10 may be provided with a bias mechanism 280 exerting a bias
force of about 1 lbs. to 4 lbs. Thus, where the injector 10 of the present invention
includes both a bias mechanism 280 and a multistage driver 154, the effective
insertion force provided by the injector 10 can be tailored, as desired, to minimize
subject discomfort.
[0048] A range of about 1 lbs. to about 7 lbs. is specifically discussed in
relation to injectors 10 of the present invention including multistage and single
stage drivers 152, 154, because it is thought that, where a needle having a gauge
ranging from 21 gauge to 31 gauge is used, an effective insertion force of between
about 1 lbs. and 7 lbs. will minimize subject discomfort. However, the injector 10
of the present invention is not limited to those designs providing an effective
insertion force ranging from about 1 lbs. to about 7 lbs. The design of the injector
10 of the present invention is highly flexible, and the injector 10 of the present
invention may be designed to insert the needle 250 included in the dispenser 200
with virtually any desired force.
[0049] FIG. 14 through FIG. 15 illustrate a first syringe cartridge 204 that may
be used as a dispenser 200 in an injector 10 according to the present invention
(See FIG. 1, FIG. 9 and FIG. 10). As can be seen in FIG. 14, the dispenser 200
includes a sleeve 202 and a syringe cartridge 204. The sleeve 202 is attached to
the body 12 of the injector 10 and is designed to receive and retain the syringe
cartridge 204. Any suitable attachment mechanism may be used to attach the
sleeve 202 to the body 12 of the injector 10. For example, the sleeve 202 may be
permanently attached to the body 12 of the injector 10 through a bonding process,
a welding process, or by any other suitable means for permanent attachment.
Alternatively, the sleeve 202 may be removably attached to body 12 of the
injector 10 using, for example, a threading mechanism, a snap-fit connection, a
male/female connection mechanism, or any other suitable mechanism providing
non-permanent attachment. The sleeve 202 facilitates removable attachment of
the syringe cartridge 204 and serves to protect the pneumatic cylinder 158 when
the syringe cartridge 204 is removed.
[0050] FIG. 14 provides an exploded view of the sleeve 202, syringe cartridge
204, and the components which facilitate releasable mounting of the syringe
cartridge 204 within the sleeve 202. As can be seen in FIG. 14, the sleeve 202
includes a spacer ring 206 and a locking ring 208. Once the sleeve is mounted to
the body 12 of the injector 10, the locking ring 208 and the spacer ring 206 are
maintained within the sleeve 202 by a retaining member 212, such as a ridge or
any other suitable structure or device. The syringe cartridge 204 is advanced
through the sleeve 202 until a seal 216 included at the proximal end 218 of the
syringe cartridge 204 abuts the body 12 of the injector 10. Once the syringe
cartridge 204 is fully advanced, it may be locked into place by applying a first
torque, which causes locking members 223, included on the casing 219 of the
syringe cartridge 204, to engage biased locking tabs 222 included in the locking
ring 208. After use, the syringe cartridge 204 may be removed from the injector
10 by applying a second torque, which disengages the biased locking tabs 222
from the locking members 223 of the syringe cartridge 204. It is to be understood,
however, that the dispenser 200 of the first embodiment of the injector 10 need
not include a sleeve 202 and the syringe cartridge 204 may be permanently
attached to the injector 10, particularly where the injector 10 is designed for a
single use.
[0051] FIG. 15 provides a cross-sectional view of the syringe cartridge 204.
As can be seen by reference to FIG. 15, the casing 219 of the syringe cartridge
204 houses a biasing mechanism 280 and a syringe 211 having a piston 270 and a
needle 250, such as a hypodermic needle, through which medicament 220 is
delivered. The biasing mechanism 280 supports the syringe 211 within the casing
219 and biases the reservoir 210 and needle 250 in a retracted position. The
biasing mechanism 280 preferably includes a coil spring 282 through which the
syringe 211 and needle 250 can be disposed.
[0052] The syringe cartridge 204 shown in FIG. 14 through FIG. 15 also
includes an adjustable tip 230, which engages the distal end 221 of the casing 219
in any manner that permits the adjustable tip 230 to be advanced or retracted
relative to the distal end 221 of the casing 219. For instance, the adjustable tip
230 may include a first threaded area and the distal end 221 of the casing 219 may
include a second threaded area complimentary to the first threaded area, allowing
the adjustable tip 230 to be advanced or retracted along the distal end 221 of the
casing 219. However, the adjustable tip 230 may be mounted by any other
suitable mechanism, such as a snap-fit mechanism or a ratchet fit mechanism, that
allows the adjustable tip 230 to be advanced or retracted along the distal end 221
of the casing 219. Though the syringe cartridge 204 need not include an
adjustable tip 230, providing the syringe cartridge with an adjustable tip 230
facilitates simple adjustment of the depth to which the needle 250 is inserted.
[0053] FIG. 16 through FIG. 22 illustrate a collapsible syringe cartridge 240
hat may be used in an injector 10 according to the present invention. The
collapsible syringe cartridge 240 includes a casing 219 having a collapsible
portion 290 and a fixed portion 292. A syringe 211 serves as the reservoir 210.
The syringe 211 terminates in a needle 250 of desired gauge and includes a piston
270. The collapsible syringe cartridge 240 further includes a bias mechanism 280
including a coil spring 282, which maintains the syringe 211 and needle 250 in a
normally retracted position within the casing 219. Advantageously, the
collapsible portion 290 of the casing 219 allows the use of a shorter piston 156,
170 within the driver 150 and thereby facilitates the construction of a shorter
injector 10.
[0054] As can be seen in FIG. 5, FIG. 6, and FIG. 16 through FIG. 22, the
casing 219 of the collapsible syringe cartridge 240 is designed to facilitate
mounting of the collapsible syringe cartridge 240 within the body 12 of the
injector 10. The casing 219 of the collapsible syringe cartridge 240 is not only
shaped and sized to fit within a complimentary mounting area 242 provided in the
body 12 of the injector 10, but the casing 219 also provides a suitable mechanism
by which the collapsible syringe cartridge 240 may be mounted to an injector 10
of the present invention. For example, as is shown in FIG. 5, FIG. 6, and FIG. 16
through FIG. 22, the casing 219 may include a first threaded area that is
complimentary to a second threaded area formed within the body 12 of the
injector 10. Alternatively, the casing 219 of the collapsible syringe cartridge 240
may include one or more locking tabs 246 (shown in FIG. 20 through FIG. 22)
complimentary to one or more recesses (not shown) formed within the body 12 of
the injector 10. Though FIG. 5, FIG. 6, and FIG. 16 through FIG. 22 show
collapsible syringe cartridges 240 including two specific mounting mechanisms, a
collapsible syringe cartridge 240 useful with an injector 10 of the present
invention may incorporate any other suitable mounting mechanism.
[0055] The collapsible portion 290 of the casing 219 is sized such that it can
be displaced into and out of the fixed portion 292 of the casing 219. To help
ensure that the collapsible portion 290 is not entirely displaced from the fixed
portion 292, the distal end 293 of the collapsible portion 290 may be provided
with a first lip 294 and the proximal end 295 of the fixed portion 292 may be
provided with a second lip 296. As the collapsible portion 290 extends out of the
fixed portion 292, the first lip 294 engages the second lip 296, which inhibits
further extension of the collapsible portion 290 from the fixed portion 292. The
collapsible portion 290 is also shaped and sized to receive the coil spring 282 that
serves as the biasing mechanism 280. The coil spring 282 maintains the
collapsible portion 290 in a normally extended position, which corresponds to the
retracted position of the syringe 211 and needle 250.
[0056] The proximal end 297 of the collapsible portion 290 includes an orifice
298 sized to permit positioning of the syringe 212 within the collapsible the
syringe cartridge 240. However, the orifice 298 is also sized to catch the proximal
end 213 of the syringe 211 as the syringe 211 is positioned through the orifice
298. Thus, as an injection or insertion force is applied to the piston 270 included
in the syringe 211 and the syringe 211 is displaced against the coil spring 282, the
collapsible portion 290 is displaced with the syringe 211 into the fixed portion 292
of the casing 219 (shown in FIG. 19). Significantly, because the collapsible
portion 290 is displaced within the fixed portion 292 of casing 219, the plunger
166 of the multistage or single stage piston 156, 170 included in the driver 150
need only be long enough to expel a desired dose of medicament 220 from the
syringe 211. In contrast, where a syringe cartridge does not include a collapsible
portion 290, such as the syringe cartridge 204 shown in FIG. 14 and FIG. 15, the
plunger 166 of the piston 156, 170 must be long enough to both displace the
syringe 211 within the syringe cartridge 204 and expel a desired dose of
medicament 220.
[0057] If desired, the collapsible syringe cartridge 240 may be provided with a
locking mechanism that serves to minimize accidental compression of the syringe
211 before the collapsible syringe cartridge 240 is mounted to an injector 10. For
example, as shown in FIG. 20 through FIG. 22, the collapsible portion may
include one or more ears 272, which extend away from the outer surface of the
collapsible portion 290. When the collapsible portion 290 is in a locked position,
the one or more ears 272 cannot pass through the proximal end 295 of the fixed
portion 292 of the casing 219, thereby preventing the collapsible portion 290 from
being displaced within the fixed portion 292. In an unlocked position, the one or
more ears 272 are aligned with one or more corresponding passages 276 provided
in the proximal end 295 of the fixed portion 292 of the casing 219. The one or
more corresponding passages 276 allow the one or more ears 272 to pass through
the proximal end 295 of the fixed portion 292 of the casing 219, thereby allowing
the collapsible portion 290 to be displaced within the fixed portion 292.
Preferably, the body 12 of the injector 10 and the collapsible syringe cartridge 240
are designed such that mounting the collapsible syringe cartridge 240 to the
injector 10 aligns the one or more ears 272 with the one or more corresponding
passages 276, while removing the collapsible syringe cartridge 240 from the
injector 10 misaligns the one or more ears 272 with one or more corresponding
passages 276.
[00581 If desired, the collapsible syringe cartridge 240 may also include an
adjustable tip 230, which engages the distal end 221 of the casing 219 in any
manner that permits the adjustable tip 230 to be advanced or retracted relative to
the distal end 221 of the casing 219. Again, the adjustable tip 230 may include a
first threaded area complimentary to a second threaded area provided at the distal
end 221 of the casing 219. However, adjustable tip 230 may be mounted by any
other suitable mechanism, such as a snap-fit mechanism or a ratchet fit
mechanism, that allows the adjustable tip 230 to be advanced or retracted along
the distal end 221 of the casing 219.
[0059] The injector 10 of the present invention may also include a pressure
relief mechanism for dissipating gas pressure developed within the pneumatic
cylinder 158. For example, the injector 10 of the present invention may be
designed to allow venting of pressurized gas once the piston 170 reaches a
predetermined position within the pneumatic cylinder 158. As is shown in FIG. 5,
the pneumatic cylinder 158 of the driver 150 may terminate in a vent chamber
500. The vent chamber 500 is sized so that the seal created between the piston
170 and the pneumatic cylinder 158 is broken as the piston 170 reaches the end of
a predetermined stroke. Once the seal between the piston 170 and the pneumatic
cylinder 158 is broken, pressurized gas escapes from the pneumatic cylinder 158
and into the vent chamber 500. The injector shown in FIG. 5 is designed such that
pressurized gas moving into the vent chamber 500 is free to escape the injector 10
by flowing around or through the casing 219 of the dispenser 200. If desired,
however, the vent chamber 500 may additionally include a fluid path (not shown)
extending from the vent chamber 500, through the body 12 of the injector 10, and
to the exterior surface 13 of the body 12. Such a fluid path may be desirable or
necessary where more rapid venting of the pressurized gas is desired or where the
design of the injector 10 does not permit pressurized gas flowing into the vent
chamber 500 to escape around or through the dispenser 200.
[0060] FIG. 6 illustrates yet another pressure relief mechanism that may be
incorporated into a plunger assembly 124 serving as the actuator 100 of an
injector 10 of the present invention. Such a pressure relief mechanism includes a
fluid path 510 formed within the body 130 of the plunger 128 of the plunger
assembly 124. The fluid path 510 includes a vent512 formed in the side of the
plunger 128. When the vent 512 is located on the interior side of sealing member
18 of the plunger assembly 124, a sealed environment is maintained within the
injector 10. However, if the plunger 128 is displaced such that the vent 512 is
located on the exterior side of the sealing member, fluid communication between
the interior and exterior of the injector 10 is permitted. As the plunger 128 is
depressed and the microcylinder 52 is compromised, the pressurized gas escaping
from the microcylinder 52 enters the fluid path 510 and acts against the plunger
128, creating a displacement force sufficient to displace the plunger 128 such that
the vent 512 is positioned on the exterior side of the sealing member 18.
However, as long as the plunger 128 is depressed with a force equal to or greater
than the displacement force resulting from the pressurized gas, the plunger 128
will not be displaced and fluid communication between the interior of the injector
10 and the exterior environment will be prevented. Once the plunger 128 is
released, however, such as at the end of the delivery cycle, the plunger 128 will be
displaced such that the vent 512 is positioned on the exterior side of the sealing
element 18 and pressurized gas contained within the injector 10 will exit the
injector 10 through the plunger 128.
[0061] Where, the injector 10 includes a safety mechanism 20, the safety
mechanism 20 may be designed to help ensure proper functioning of the pressure
relief mechanism shown in FIG. 6. For instance, as shown in FIG. 6, the width of
the slot 30 included in the first portion 22 of the safety mechanism 20 is smaller
than the width of the body 130 of the plunger 128. Thus, when the safety
mechanism 20 is moved out of the safe position, the plunger 128 can not be
displaced to such an extent that the vent 512 formed in the plunger 128 is
positioned on the exterior side of the sealing member 18. However, as the safety
mechanism 20 moves back into the safe position, the slot 30 opens into port 31,
which is sized to allow the body 130 of the plunger 128 to be displaced such that
the orifice 512 is positioned on the exterior side of the sealing member 18.
Moreover, the stop 32 of the safety mechanism 20 may include a lip 33, which
prevents the plunger 128 from being entirely expelled from the passageway 126 of
the plunger mechanism 124. Thus, the injector 10 of the present invention may
include a safety mechanism 20 which not only minimizes the possibility of
accidentally firing the injector 10, but which also works in concert with a venting
mechanism to ensure that pressurized gas is properly vented from the injector 10.
[0062] Significantly, the driver 150 and dispenser 200 of the injector 10 of the
present invention need not be separate devices. As shown in FIG. 23 and FIG. 24,
the dispenser 200 may incorporate the driver to simplify construction of injector
10. In such an instance, the reservoir 210, such as a syringe 211, of the dispenser
200 serves as at least a portion of the pneumatic cylinder of the driver, and the
piston 270 of the dispenser 200 may be designed as a single stage piston 156 or a
multistage piston 170 that acts directly against medicament 220 contained within
the reservoir 210. As it reduces the size of the injector 10 and decreases the
amount of materials used to manufacture the injector 10, incorporating the driver
within the dispenser 200 provides a more economical and portable device. Where
the driver and dispenser 200 are integrated, however, the cross-sectional diameter
of the piston 156,170 is limited to the maximum interior diameter of the reservoir
210. Though the injectors 10 illustrated in FIG. 23 and FIG. 24 do not include a
pressure regulator or a restrictor, if desired, injectors 10 including an integrated
driver and dispenser 200 may be provided with a pressure regulator or restrictor,
such as those already described.
[0063] In addition, the injector of the present invention may be designed for a
single use or for multiple uses. Where the injector is designed for a single use,
each of the components of the injector are designed to be disposed after a single
use and may be permanently integrated into a single housing. However, where the
injector of the present invention is designed as a multiple use injector, at least one
of the components of the injector is designed for repetitive use. Regardless of
whether or not the actuator and driver a multiple use injector of the present
invention are designed as discrete devices, both the pressurized gas source and the
dispenser of a multi-use injector according to the present invention will are
preferably be designed as modular components. Such a design facilitates the easy
attachment and detachment of the pressurized gas source and the dispenser to and
from the actuator or the driver of the injector.
[0064J The injector of the present invention is desirable because the design of
the injector is flexible, allowing the injector of the present invention to be
designed to deliver medicaments exhibiting a wide range of viscosities. In
particular, the injector of the present invention is well suited for the delivery of
viscous medicaments and may be designed to deliver viscous medicaments having
viscosities of 1 Poise or greater, 10 Poise or greater, 20 Poise or greater, 50 Poise
or greater, or even 100 Poise or greater. Generally, the injector of the present
invention will be configured to exert an injection force ranging from about 5 lbs.
to about 200 lbs. However, the design of the injector of the present invention is
not limited to an injector providing an injection force falling within the range of
between about 5 lbs. and 200 lbs. The injector of the present invention may be
configured to exert any desired injection force tailored to ensure delivery of a
desired dose of a chosen medicament within a desired amount of time.
[0065] The Hagen-Poiseuille Law may be used to determine the injection
force required to deliver a desired dose of a chosen medicament within a
predetermined amount of time. For example, in order to deliver 0.5 cc of a
medicament having a viscosity of 200 Poise within 10 seconds via a syringe
having an internal diameter of 4.5 mm and a 0.5 inch needle having an internal
diameter of 0.012 inches (a 24 gauge needle), the Hagen-Poiseuille Law indicates
that an injection force of approximately 100 pounds is required. Such a force
determination maybe undertaken for any dose of any chosen medicament that is to
be delivered through a chosen syringe and needle. As is easily appreciated, even
when the viscosity of the medicament remains constant, adjusting one or more of
the variables represented in the Hagen-Poiseuille Law will result in a different
required injection force. Therefore, even where the rheological properties of the
medicament to be delivered remain the same, greater or lesser injection forces
may be needed, depending on, for example, the desire delivery time, the length
and gauge of the needle to be used, and the diameter of the syringe or other
reservoir used to contain the medicament before it is expelled through the needle.
[0066] Once the desired injection force is determined, the various components
of the injector of the present invention may be adapted to generate a desired force,
forces, or force profile. As can be appreciated from the foregoing description, the
pressurized gas source and driver of the injector of the present invention can be
configured to achieve a desired force, forces, or force profile. For example, a
pressure of 197 psi can be achieved within a pneumatic cylinder having an
internal diameter of 0.75 inches and an internal length of 2.50 inches by providing
the injector of the present invention with a commercially available microcylinder
having internal measuring 0.35 inches x 1.50 inches and containing gas stored at
1,750 psi. As the internal diameter of the pneumatic cylinder equals 0.75 inches,
the injection stage of a single stage or multistage piston included within the driver
would also measure 0.75 inches, resulting in the generation of an injection force
of 87 lbs. Additionally, if a pressure of 197 psi is produced within the pneumatic
cylinder, providing a the driver with a multistage piston having an insertion stage
measuring 0.20 inches in diameter would result in the generation of an insertion
force of 6 lbs. If substantially constant insertion or injection forces are required or
desired, the injector of the present invention may be configured to include a
pressure regulator or restrictor, such as those already described herein. Although
the injector of the present invention is preferably configured to generate injection
forces ranging between about 5 lbs. and about 120 lbs., and, where desired, to
provide insertion forces or effective insertion ranging between about 1 lbs. and 7
lbs., the injector of the present invention is not limited to such configurations and
may be designed to provide desired injection or insertion forces falling outside
those presently preferred ranges.
[0067] In addition, the injector of the present invention is desirable because
the drive mechanism of the injector is relatively simple and operates relatively
quietly, without the transmission of significant impact or recoil forces. Where the
injector of the present invention includes a multistage driver, the injector of the
present invention is capable of generating insertion and injection forces using a
single driving mechanism. Moreover, the specifications and configuration of the
pressurized gas source and driver of the injector of the present are easily adjusted
to provide insertion forces that minimize subject discomfort, while providing
injection forces that maximize delivery efficiency of even highly viscous
medicaments. Even where the injector of the present invention includes a single
stage driver, the injector of the present invention may be designed to generate an
injection force suitable for delivering a desired dose of a chosen medicament,
while providing an effective insertion force tailored to minimize subject
discomfort. Due to the simplicity of the pneumatic driving mechanism used in the
injector of the present invention, moving parts within the injector are limited and
operate relatively unobtrusively, allowing the injector of the present invention to
function without generating excess noise or transmitting significant impact or
recoil forces.
[0068] The components of the injector of the present invention may be
manufactured using any suitable materials and known manufacturing processes.
For example, known metals, metal alloys, composites, or natural or synthetic
rubber or polymer materials may be used to fabricate the dispenser, the driver, the
actuator, and, where included in the pressurized gas source, the cap. Moreover,
suitable glass materials may be used in the fabrication of one or more components
of the dispenser. Such materials may be molded, machined, cast, or formed
through other suitable manufacturing process to produce components of desired
shape and size. Specific materials that may be used to fabricate one or more of
the various components and subcomponents of the injector of the present
invention include, for example, aluminum and aluminum alloys, stainless steel,
such as 304 or 316 stainless steel, glass reinforced nylon, liquid crystal polymer
(LCP), PEEK polymer, and Delryn polymer. Of particular use in fabricating the
reservoir and casing of the dispenser of the injector of the present invention are
304 stainless steel, 316 stainless steel, LCP, and PEEK polymer. However, as will
be appreciated by those of skill in the art, the injector of the present invention may
be fabricated using any material and manufacturing process providing an injector
capable of withstanding the anticipated operational stresses of an injector designed
according to the present invention.
[0069] The present invention also includes a method of injecting viscous
medicaments. In each of its embodiments, the method of the present invention
includes providing a medicament, providing a needle of a desired gauge, inserting
the needle into the tissue of the subject, and generating an injection force
sufficient to drive the viscous medicament through the needle and into the tissue
of the subject. Preferably, the medicament provided in the method of the present
invention is a viscous medicament (i.e., a medicament having a viscosity greater
than 1 Poise). Even more preferably, the method of the present invention includes
providing a medicament having a viscosity of 10 Poise or greater, 20 Poise or
greater, 50 Poise or greater, or 100 Poise or greater. Though the medicament
provided in the method of the present invention is preferably a viscous
medicament, the method of the present invention is not so limited and may include
providing a medicament exhibiting a viscosity below 1 Poise.
[0070] Because the comfort of the subject generally increases as the gauge of
the needle decreases (i.e., the inner diameter of the needle decreases), the needle
provided in the method of the present invention preferably has a gauge ranging
between 21 gauge and 31 gauge. Even more preferably, the gauge of the needle
provided in the method of present invention ranges between 24 gauge and 31
gauge, and most preferably, the gauge of the needle provided in the method of the
present invention ranges between 27 and 31 gauge. However, such needle gauge
ranges are simply presently preferred ranges. The gauge of the needle used in the
method of the present invention will vary depending on, for example, the viscosity
of the medicament to be injected, the nature of the subject, the tissue of the subject
where the injection will take place, the injection force generated, and the desired
time for injection. Therefore, the gauge and length of the needle used in the
method of the present invention may vary with the desired application.
[0071] Further, the injection force generated in the method of the present
invention is sufficient to deliver a desired dose of the provided medicament within
a suitable amount of time. Preferably, the injection force is sufficient to deliver a
desired dose of the provided medicament within 10 seconds. Even more
preferably, the injection force generated in the method of the present invention is
sufficient to deliver a desired dose of the provided medicament within 5 seconds.
In order to accomplish delivery of a desired dose of the provided medicament
within the presently preferred times, the injection force generated in the method of
the present invention will generally range between about 5 lbs. and 200 lbs.
However, as is true of each of the other aspects of the method of the present
invention, the magnitude of the injection force generated in the method of the
present invention is variable and will depend on, for example, the dispenser
provided, the medicament provided and the dose of the medicament to be
delivered. The injection force generated in the method of the present invention
need only be of sufficient magnitude to deliver a desired dose of the provided
medicament within a suitable amount of time. Thus, depending upon the
application, the injection force generated in the method of the present invention
may be lower than 5 lbs. or higher than 200 lbs. Moreover, the method of the
present invention is not limited to the generation of injection forces sufficient to
deliver a desired dose of the provided medicament within the presently preferred
amounts of time.
[0072] In another embodiment, the method of the present invention further
includes providing an insertion force or an effective insertion force, which is less
than the injection force and may be tailored to minimize subject discomfort as the
needle is inserted into the tissue of the subject. For example, where the intended
subject is human and the gauge of the needle provided ranges from between 21
gauge and 31 gauge, an insertion force of between about 1 pound and 7 pounds is
presently preferred, with an injection force of between about 1 and 4 pounds being
even more preferable. However, the magnitude of an insertion generated in the
method of the present invention may vary according to several factors, such as the
anticipated subject, the gauge of the needle to be inserted into the tissue of the
subject, and the desired avenue of injection (e.g., subcutaneous, intramuscular, or
intra-articular. Further, where the method of the present invention includes
providing an insertion force, both the injection force and the insertion force are
preferably generated using a single drive mechanism.
(0073] In each of its embodiments, the method of the present invention may
further include providing an injector of the present invention. For example, FIG.
26 through FIG. 29 illustrate one embodiment of the method of the present
invention carried out with an injector according to the present invention. FIG. 26
illustrates the injector providing a needle 250 and a medicament placed against the
tissue 600 of a subject. As shown in FIG. 27, actuation of the actuator 100 causes
pressurized gas from the microcylinder 52 to the driver 150, and as pressurized
gas acts against the insertion stage 172 of the multistage piston 170, an insertion
force is generated, which drives the syringe 211 and needle 250 against the bias
mechanism 280 and into the tissue 600 of the subject. Once the seal formed
between the insertion stage 172 and the wall 174 of the first chamber 167 of the
pneumatic cylinder 158 breaks, pressurized gas acts against the injection stage 162
of the multistage piston 170, providing an injection force. The injection force is
greater than the insertion force and is transmitted to the plunger 270 of the syringe
211. As the multistage piston 170 is driven through the second chamber 168 of
the pneumatic cylinder 158 with the injection force, the plunger 270 drives a
desired dose of medicament 220 from the syringe 211 and into the tissue 600 of
the subject (shown in FIG. 28). Preferably, once a desired amount of medicament
220 is delivered, the forward progress of the multistage piston 154 terminates and
the pressure within the pneumatic cylinder 152 dissipates. As the pressure within
the pneumatic cylinder 152 dissipates, the force transmitted by the multistage
piston 170 to plunger 270 also dissipates and becomes incapable of overcoming
the bias force exerted by the biasing mechanism 280. As the force exerted by the
multistage piston is not longer equal to or greater than the bias force exerted by
the bias mechanism 280, the syringe 211 and needle 250 are automatically
retracted by the bias mechanism 280 into the casing 219 of the dispenser 200
(shown in FIG. 29).
[0074] The embodiment of the method of the present invention illustrated in
FIG. 26 through FIG. 29, however, is merely exemplary and does not limit the
scope of the method of the present invention. In particular, the method of the
present invention is not limited to providing the injector illustrated in FIG. 26
through FIG. 29. Any injector of the present invention may be used to carry out
one or more embodiments of the method of the present invention.
Example 1
[0075J FIG. 25 provides a graph illustrating that the forces exerted by the
injector of the present invention may be adjusted simply by altering the pressure
generated within the pneumatic cylinder of the driver of the injector or by altering
the surface area of the piston included within the driver. As can be appreciated by
reference to the graph, where a given pressure is generated, the forces exerted by
the piston increase as the diameter of the piston increases and decrease as the
diameter of the piston decreases. In addition, where a piston of a given diameter
is provided, the forces exerted by the piston increase as the pressure within the
pneumatic cylinder increases and decrease as the pressure within the pneumatic
cylinder decreases. Therefore, the information graphed in FIG. 25 illustrates that
the force, forces, or force profiles exerted by the driver of an injector of the
present invention may tailored to suit one or more desired applications simply by
altering the pressure generated within the pneumatic cylinder of the driver or by
altering the surface area of the insertion or injection stages included in the
multistage or single stage piston provided within the pneumatic piston.
Example 2
[0076J An injector according to the present invention was tested to determine
the injection time required to deliver a material of chosen viscosity through
needles having different gauges. The injector used in the tests utilized a
pressurized gas source including a commercially available 12 gram sealed
microcylinder that was filled with 0.2 grams of nitrogen at 1,750 psi. The actuator
of the injector included a piercing mechanism, and threading a cap containing the
sealed microcylinder onto the body of the injector such that the seal of the
microcylinder was compromised by the piercing mechanism actuated the injector.
The injector included a restrictor formed of a plate having an orifice measuring
0.0015 inches in diameter, and the restrictor was positioned between the piercing
mechanism of the actuator and the driver of the injector. The driver of the injector
was a multistage driver including a pneumatic cylinder having first and second
chambers and a multistage piston including an insertion stage and an injection
stage. The pneumatic cylinder was 2.50 inches in length and had a maximum
internal diameter of 0.75 inches. The insertion stage of the multistage piston
measured 0.2 inches in diameter, and the injection stage of the multistage piston
measured 0.75 inches in diameter. Upon actuation of the injector, the multistage
driver generated an insertion force of about 6 lbs. and an injection force of about
84 lbs.
[0077] In each test the injector was provided with a dispenser having a sleeve
and syringe cartridge as illustrated in FIG. 14 and 15. In each test the syringe of
the syringe cartridge was pre-filled with 0.5 cc of a non-Newtonian formulation
having a static viscosity of about 1,000 Poise and a dynamic viscosity of about
200 Poise as measured at a 1.0 sec-1 shear rate and 25°C using a Haake
Rheometer. However, the syringe cartridge provided in the first test included a
0.5 inch 24 gauge needle, while the syringe cartridge provided in the second test
included a 0.5 inch 27 gauge needle. Before each test, the formulation was heated
to between about 41° C. and 43° C.
[0078] The results of the tests are provided in Table 1. As can be interpreted
from Table 1, the gauge of the needle directly affects the time required to deliver a
chosen formulation, all else being the same. However, in each test the desired
amount of the chosen formulation was delivered well within 10 seconds.
Moreover, in each test the injector produced very little noise and did not transmit
noticeable impact or recoil forces.
WE CLAIM:
1. A device for injecting a viscous medicament comprising:
a dispenser comprising a reservoir for containing a viscous
medicament, a needle for injecting the medicament, and a piston for driving the
medicament through the needle, the reservoir and needle movably disposed
within a casing, the needle having a gauge equal to or greater than about 21
gauge; and
a driver activated by the flow of pressurized gas, the driver configured
to exert a force against the piston sufficient to drive the viscous medicament
through the needle.
2. The device as claimed in claim 1, further comprising a pressurized gas
source and an actuator which actuates flow of pressurized gas from the
pressurized gas source to the driver.
3. The device as claimed in claim 1, wherein the viscous medicament has a
viscosity greater than about 5 poise.
4. The device as claimed in claim 1, wherein the viscous medicament has a
viscosity greater than about 10 poise.
5. The device as claimed in claim 1, wherein the viscous medicament has a
viscosity greater than about 50 poise.
6. The device as claimed inclaim 1, wherein the viscous medicament has a
viscosity greater than about 100 poise.
7. The device as claimed in claim 1, wherein the driver comprises a
multistage piston configured to exert at least a first force and a second force
against the dispenser.
8. The device as claimed in claim 1, wherein the driver comprises a
multistage piston configured to exert a first force and a second force against the
dispenser, the second force being greater than the first force.
9. The device as claimed in claim 8, wherein the multistage piston is
configured such that the first force is less than or equal to about 7 lbs and the
second force is sufficient to inject the viscous medicament through the needle.
10. The device as claimed in claim 1, wherein the guage of the needle ranges
from about 27 gauge to about 31 gauge.
11. The device as claimed in claim 1, wherein the device is configured to
inject up to 0.5 cc of the viscous medicament through the needle within about 10
seconds..
12. The device as claimed in claim 1, wherein the device is configured to
inject up to about 0.5 cc of the viscous medicament through the needle within
about 5 seconds.
13. The device as claimed in claim 2, wherein the pressurized gas source,
driver, and dispenser are configured to inject up to about 0.5 cc of the viscous
medicament through the needle within about 10 seconds.
14. The device as claimed in claim 13, wherein the pressurized gas source,
the driver, and the dispenser are configured to inject up to about 0.5 cc of the
viscous medicament through the needle within about 5 seconds.
15. The device as claimed in claim 8, wherein the multistage piston of the
device is configured to exert a first force that is less than a second force.
16. The device as claimed in claim 8, wherein each stage of the multistage
piston is characterized by a different surface area.
17. The device as claimed in claim 1, further comprising a bias mechanism
which maintains the needle in a retracted position within the casing until the
force is exerted against the piston.
18. The device as claimed in claim 17, wherein the force is sufficient to extend
the needle from the retracted position.

The present invention provides a pneumatic injector (10) that includes a
pressurized gas source (50), an actuator (100), a driver (150),and a
dispenser (200). The dispenser (200) of the injector (10) includes a
reservoir (210) for containing a desired amount of a chosen medicament
(220) and a needle (250), such as a hypodermic needle, suitable for
subcutaneous, intramuscular, or intra-articular delivery of the chosen
medicament (220). The actuator (100) actuates the transmission of
pressurized gas from the pressurized gas source (50) to the driver (150)
and as pressurized gas is delivered to the driver (150), the driver exerts
at least an injection force. The injection force is of a sufficient magnitude
to expel a chosen medicament through the needle of the dispenser within
a desired amount of time. Advantageously, the design of the injector of
the present invention is extremely flexible, allowing the injector to be
designed to deliver a wide range of medicaments in virtually any human
or veterinary context calling for the injection of the subcutaneous,
intramuscular, or intra-articular injection of medicament

Documents:

598-KOLNP-2004-FORM-27.pdf

598-kolnp-2004-granted-abstract.pdf

598-kolnp-2004-granted-claims.pdf

598-kolnp-2004-granted-correspondence.pdf

598-kolnp-2004-granted-description (complete).pdf

598-kolnp-2004-granted-drawings.pdf

598-kolnp-2004-granted-examination report.pdf

598-kolnp-2004-granted-form 1.pdf

598-kolnp-2004-granted-form 13.pdf

598-kolnp-2004-granted-form 18.pdf

598-kolnp-2004-granted-form 2.pdf

598-kolnp-2004-granted-form 26.pdf

598-kolnp-2004-granted-form 3.pdf

598-kolnp-2004-granted-form 5.pdf

598-kolnp-2004-granted-reply to examination report.pdf

598-kolnp-2004-granted-specification.pdf

598-kolnp-2004-granted-translated copy of priority document.pdf


Patent Number 233787
Indian Patent Application Number 598/KOLNP/2004
PG Journal Number 15/2099
Publication Date 10-Apr-2009
Grant Date 08-Apr-2009
Date of Filing 06-May-2004
Name of Patentee ALZA CORPORATION
Applicant Address 1900, CHARLESTON ROAD, P.O. BOX 7210, MOUNTAIN VIEW, CA
Inventors:
# Inventor's Name Inventor's Address
1 GILBERT SCOTT JAY 1275 AVY AVENUE, MENLO PARK, CA 91025
2 DE LA SERNA PEDRO 375 PATTON AVENUE, SAN JOSE, CA 95128
PCT International Classification Number A61M 5/20
PCT International Application Number PCT/US2002/35978
PCT International Filing date 2002-11-08
PCT Conventions:
# PCT Application Number Date of Convention Priority Country
1 60/337,753 2001-11-09 U.S.A.