U.S. patent application number 15/626297 was filed with the patent office on 2017-10-05 for auto-injector apparatus.
The applicant listed for this patent is Meridian Medical Technologies, Inc.. Invention is credited to Oliver T. Harvey, Robert L. Hill, Chris J. Hurlstone, Colin J. Mathews, Clarence M. Mesa, Dominic C. Reber, James R. Stewart, Ben G. Turner, John G. Wilmot.
Application Number | 20170281854 15/626297 |
Document ID | / |
Family ID | 40230773 |
Filed Date | 2017-10-05 |
United States Patent
Application |
20170281854 |
Kind Code |
A1 |
Mathews; Colin J. ; et
al. |
October 5, 2017 |
Auto-Injector Apparatus
Abstract
An auto-injector apparatus includes a flexible container
containing a liquid medicant, a needle communicated with a
container, a housing with a container being received in the
housing, a pump disposed in the housing and positioned to engage
the flexible container and expel the medicant from the container
through the needle upon relative movement between the pump and the
container, and a main drive spring operably associated with the
needle to extend the needle from a first needle position wherein
the needle is completely received in the housing to a second needle
position wherein the needle protrudes from the housing. The pump
may be a roller.
Inventors: |
Mathews; Colin J.; (Cambs,
GB) ; Hurlstone; Chris J.; (Essex, GB) ;
Turner; Ben G.; (Leighton Buzzard, GB) ; Harvey;
Oliver T.; (Cambridge, GB) ; Reber; Dominic C.;
(Cambridge, GB) ; Wilmot; John G.; (Mount Airy,
MD) ; Mesa; Clarence M.; (Boyds, MD) ; Hill;
Robert L.; (Abingdon, MD) ; Stewart; James R.;
(Leesburg, VA) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Meridian Medical Technologies, Inc. |
Bridgewater |
NJ |
US |
|
|
Family ID: |
40230773 |
Appl. No.: |
15/626297 |
Filed: |
June 19, 2017 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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14184055 |
Feb 19, 2014 |
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15626297 |
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|
12624604 |
Nov 24, 2009 |
8690836 |
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14184055 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M 5/152 20130101;
A61M 2005/1585 20130101; A61M 5/3202 20130101; A61M 5/148 20130101;
A61M 5/326 20130101; A61M 2005/206 20130101; A61M 2005/14252
20130101; A61M 5/2425 20130101; A61M 2005/202 20130101; A61M 5/1483
20130101; A61M 5/158 20130101; A61M 5/31 20130101; A61M 2205/8287
20130101; A61M 5/2459 20130101; A61M 5/2033 20130101; A61M 5/34
20130101; A61M 5/145 20130101; A61M 5/002 20130101 |
International
Class: |
A61M 5/00 20060101
A61M005/00; A61M 5/32 20060101 A61M005/32; A61M 5/152 20060101
A61M005/152; A61M 5/20 20060101 A61M005/20; A61M 5/24 20060101
A61M005/24; A61M 5/148 20060101 A61M005/148 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 25, 2008 |
GB |
0821492.6 |
Claims
1. An auto-injector apparatus, comprising: a flexible container
containing a liquid medicament; a needle communicated with the
container; a housing comprising a housing body and an opening and a
housing lid movably attached to the housing body, the lid being
moveable between a closed position closing the opening and an open
position wherein the opening is accessible, the container being
received in the housing; a pump disposed in the housing and
positioned to engage the flexible container and expel the medicant
from the container through the needle upon relative movement
between the pump and the container; and a main drive spring
operably associated with the needle to extend the needle from a
first needle position wherein the needle is completely received in
the housing to a second needle position wherein the needle
protrudes from the housing.
2. The apparatus of claim 1, further comprising: a cocking linkage
connecting the lid to the main drive spring and the retraction
spring so that opening of the lid extends the main drive spring and
the retraction spring.
3. The apparatus of claim 1, wherein: the flexible container and
the needle are connected together as part of a replaceable
cartridge assembly replaceably received in the housing; and the
pump and the main drive spring are connected to the housing for
multiple use with sequential replaceable cartridge assemblies.
4. The apparatus of claim 1, further comprising: the housing having
a transparent window therein through which the flexible container
is visible; and an opaque secondary container in which the housing
is sealed.
5. The apparatus of claim 4, further comprising: the housing having
a transparent window therein through which the flexible container
can be viewed; and a pull strip movable between a first position
blocking the transparent window and a second position wherein the
transparent window is unblocked so that the flexible container can
be viewed prior to use.
6. The apparatus of claim 1, wherein the pump comprises an
inflatable balloon.
7. The apparatus of claim 1, wherein the pump comprises a pair of
magnets on opposite sides of the flexible container.
8. The apparatus of claim 1, wherein the pump comprises an
electro-magnet and a magnetically attracted mass on opposite sides
of the flexible container.
9. The apparatus of claim 1, wherein the pump comprises a source of
fluid pressure communicated with the interior of the flexible
container.
10. An auto-injector apparatus, comprising: a housing having a
proximal end and a distal end, the housing having a housing body
and an opening and a housing lid movably attached to the housing
body, the lid being moveable between a closed position closing the
opening and an open position wherein the opening is accessible, a
container carriage reciprocably disposed in the housing, the
container carriage including a cavity adapted to receive a medicant
container, the container carriage being movable within the housing
between first and second carriage positions; a roller disposed in
the housing and positioned to roll proximally through the cavity of
the container carriage to expel medicant from the container; and a
main drive spring operably associated with the carriage to move the
carriage proximally from its first position to its second
position.
11. The apparatus of claim 10, further comprising: a cocking
linkage connecting the lid to the main drive spring and the
retraction spring so that opening of the lid extends the main drive
spring and the retraction spring.
12. The apparatus of claim 10, wherein: the roller comprises an
integral coil of the coiled spring strip.
13. An auto-injector apparatus, comprising: a flexible container
containing a liquid medicant; a needle communicated with the
container; a roller positioned to engage the flexible container and
expel the medicant from the container upon relative movement in a
displacement direction between the roller and the container, the
roller having a rotational axis transverse to the displacement
direction; and wherein the flexible container has a width
transverse to the displacement direction, the width varying along
the displacement direction.
14. The apparatus of claim 13, further comprising: a main drive
operably associated with the roller to move the roller relative to
the container from a first engagement position relative to the
container to a second engagement position relative to the
container.
15. The apparatus of claim 14, wherein: the width of the container
at the second engagement position is greater than the width of the
container at the first engagement position, so that a speed of
injection of medicant increases during relative movement between
the first and second engagement position.
16. The apparatus of claim 15, wherein: the width of the container
continuously increases from the first engagement position to the
second engagement position.
17. The apparatus of claim 14, wherein: the width of the container
at the second engagement position is less than the width of the
container at the first engagement position, so that a speed of
injection of medicant decreases during relative movement between
the first and second engagement positions.
18. The apparatus of claim 17, wherein: the width of the container
continuously decreases from the first engagement position to the
second engagement position.
Description
[0001] This application claims priority from United Kingdom Patent
Application No. 0821492.6 for "Integrated Auto-Injector Cartridge"
filed on Nov. 25, 2008.
BACKGROUND OF THE INVENTION
1. Field of the Invention
[0002] The present invention relates generally to auto-injector
apparatus for injecting medicants into a patient.
2. Description of the Prior Art
[0003] To aid convenience in injecting drugs it is desirable to
simplify the process by inserting the needle into the delivery
site, delivering the drug and subsequently sheathing the needle
with minimal user input. The prior art has included a number of
auto-injector devices for performing this process. Most prior art
auto-injectors use glass based syringes or cartridges as the
primary packaging for the drug or medicant.
[0004] There is a continuing need for improved auto-injector
apparatus that are simple and reliable in their use and economical
in their manufacture.
SUMMARY OF THE INVENTION
[0005] In one aspect an auto-injector apparatus includes a flexible
container containing a liquid medicant, a needle communicated with
the flexible container, a housing with the container being received
in the housing, a pump disposed in the housing and positioned to
engage the flexible container and expel the medicant from the
container through the needle upon relative movement between the
pump and the container, and a main drive spring operably associated
with the needle to extend the needle from a first needle position
wherein the needle is completely received in the housing to the
second needle position wherein the needle protrudes from the
housing. The pump may include a roller.
[0006] In a second aspect a method of auto-injecting a liquid
medicant into a patient includes placing a proximal end of an
auto-injector apparatus against the patient's body, releasing a
main spring, driving a needle proximally within the apparatus with
the main drive spring so that the needle extends out of the
proximal end of the apparatus thereby inserting the needle in the
patient's body, and creating relative motion between a pump and a
flexible medicant container within the apparatus and thereby
forcing the medicant out of the flexible container through the
needle into the patient's body. The pump may include a roller.
[0007] In another aspect an auto-injector apparatus includes a
flexible container containing a liquid medicant, a needle
communicated with the container, and a roller positioned to engage
the flexible container and expel the medicant from the container
upon relative movement in a displacement direction between the
roller and the container, wherein the flexible container has a
width transverse to the displacement direction and the width varies
along the displacement direction.
[0008] Numerous objects, features, and advantages of the present
invention will be readily apparent to those skilled in the art upon
a reading of the following disclosure when taken in conjunction
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
[0009] FIGS. 1A-1D comprise a schematic series of figures
illustrating the manufacture and the use of an embodiment of the
auto-injector apparatus.
[0010] FIG. 1A illustrates the manufacture of the embodiment of
FIGS. 1A-1D.
[0011] FIG. 1B illustrates the embodiment of FIGS. 1A-1D ready for
use.
[0012] FIG. 1C illustrates an intermediate step in the use of the
embodiment of FIGS. 1A-1D wherein the needle has been uncovered as
it would during insertion into a patient's body.
[0013] FIG. 1D illustrates a further stage in the use of the
embodiment of FIGS. 1A-1D wherein a coil strip spring has rolled
over the flexible cartridge to inject the medicant.
[0014] FIGS. 2A-2G comprise a sequential series of illustrations of
the steps of usage of an auto-injector apparatus having an injector
device using replaceable cartridges.
[0015] FIG. 2A shows the device after usage and ready for
reloading.
[0016] FIG. 2B shows the device opened for removal of the spent
cartridge.
[0017] FIG. 2C shows a replacement cartridge in place within the
device.
[0018] FIG. 2D shows the device closed and ready for use.
[0019] FIG. 2E shows the device as it would appear with its
proximal end engaged against the patient's body and with a trigger
on its distal end depressed.
[0020] FIG. 2F illustrates the device with the needle extended from
the device as it would appear during insertion into the patient's
body and injection of the medicant.
[0021] FIG. 2G shows the device with the needle withdrawn and back
in the same condition as FIG. 2A.
[0022] FIG. 3 is an end view of an embodiment of a replaceable
cartridge for an auto-injector apparatus.
[0023] FIG. 4 is a right side elevation view of the apparatus of
FIG. 3.
[0024] FIG. 5 is a bottom view of the apparatus of FIG. 3.
[0025] FIG. 6 is a top plan view of the apparatus of FIG. 3.
[0026] FIG. 7 is a perspective exploded view of the apparatus of
FIG. 3.
[0027] FIGS. 8A-8B comprise a sequential series of perspective
views showing the operation of the apparatus of FIG. 3.
[0028] FIG. 8A shows a perspective view of the apparatus of FIG. 3
ready for use.
[0029] FIG. 8B shows a perspective view of the apparatus of FIG. 3
wherein a needle protection frame is shown in a collapsed position
with the needle extended therefrom for insertion into the patient
and injection of a medicant.
[0030] FIGS. 9A-9C comprise a perspective end view of the needle
protection frame and needle hub of the apparatus of FIG. 3
illustrating the manner in which a releasable interlock on the
needle hub is released upon closure of the lid of the device.
[0031] FIG. 9A shows the interlock in a locked position prior to
closure of the lid of the device.
[0032] FIG. 9B illustrates with downward vertical arrows the
application of downward force as would occur by two pins (not
shown) of the lid upon closure.
[0033] FIG. 9C shows the collapsed position of the needle
protection frame with the frame arms sliding through the needle
hub.
[0034] FIG. 10 is an exploded perspective view of an embodiment of
an auto-injector apparatus for use with replaceable cartridges.
[0035] FIGS. 11, 13, 15, 17, 19, 21 and 23 comprise a sequential
series of perspective views of the apparatus of FIG. 10 showing a
series of steps in the use of the apparatus.
[0036] FIG. 11 is a perspective view of the apparatus of FIG. 10 in
a first position prior to opening of the device and prior to
loading a cartridge in the device.
[0037] FIG. 12 is a plan view of the apparatus of FIG. 11.
[0038] FIG. 12A-A is an elevation section view of the apparatus of
FIG. 12 taken along line A-A.
[0039] FIG. 12B-B is an elevation section view of the apparatus of
FIG. 12 taken along line B-B.
[0040] FIG. 13 is a perspective view of the apparatus of FIG. 10 in
a second position wherein the lid has been opened and prior to
placement of a cartridge in the device.
[0041] FIG. 14 is a plan view of the apparatus of FIG. 13.
[0042] FIG. 14A-A is an elevation section view of the apparatus of
FIG. 14 taken along line A-A.
[0043] FIG. 14B-B is an elevation section view of the apparatus of
FIG. 14 taken along line B-B.
[0044] FIG. 15 is a perspective view of the apparatus of FIG. 10 in
a third position with a cartridge having been placed within the
device.
[0045] FIG. 16 is a plan view of the apparatus of FIG. 15.
[0046] FIG. 16A-A is an elevation section view of the apparatus of
FIG. 16 taken along line A-A.
[0047] FIG. 16B-B is an elevation section view of the apparatus of
FIG. 16 taken along line B-B.
[0048] FIG. 17 is a perspective view of the apparatus of FIG. 10 in
a fourth position with the cartridge in place and with the lid
closed.
[0049] FIG. 18 is a plan view of the apparatus of FIG. 17.
[0050] FIG. 18A-A is an elevation section view of the apparatus of
FIG. 18 taken along line A-A.
[0051] FIG. 18B-B is an elevation section view of the apparatus of
FIG. 18 taken along line B-B.
[0052] FIG. 19 is a perspective view of the apparatus of FIG. 10 in
a fifth position wherein the needle is protruding from the device
as it would upon insertion into a patient's body, but prior to
injection of the medicant into the patient.
[0053] FIG. 20 is a plan view of the apparatus of FIG. 19.
[0054] FIG. 20A-A is an elevation section view of the apparatus of
FIG. 20 taken along line A-A.
[0055] FIG. 20B-B is an elevation section view of the apparatus of
FIG. 20 taken along line B-B.
[0056] FIG. 21 is a perspective view of the apparatus of FIG. 10 in
a sixth position after the medicant has been injected into the
patient. It is noted that FIG. 21 appears the same as FIG. 19, but
the positions of the internal components have changed.
[0057] FIG. 22 is a plan view of the device of FIG. 21.
[0058] FIG. 22A-A is an elevation section view of the apparatus of
FIG. 22 taken along line A-A.
[0059] FIG. 22B-B is an elevation section view of the apparatus of
FIG. 22 taken along line B-B.
[0060] FIG. 23 is a perspective view of the embodiment of FIG. 10
in a seventh position wherein the needle has been withdrawn back
into the device.
[0061] FIG. 24 is a plan view of the device of FIG. 23.
[0062] FIG. 24A-A is an elevation section view of the apparatus of
FIG. 24 taken along line A-A.
[0063] FIG. 24B-B is an elevation section view of the apparatus of
FIG. 24 taken along line B-B.
[0064] FIG. 25 is an exploded perspective view of an embodiment of
an auto-injector apparatus designed for a single use.
[0065] FIGS. 26A-26H illustrate several variations on the size and
shape of the flexible drug container. FIG. 26A shows a container of
relatively low volume. FIG. 26B shows a container of relatively
high volume. FIG. 26C shows dual parallel containers which allow
two drugs to be mixed during injection. FIG. 26D shows dual
containers in series which allow two drug component's to be mixed
during injection. FIGS. 26E-H show several variations of a profiled
container which affects the rate of delivery of medicant.
[0066] FIG. 27 is a schematic perspective view of an embodiment of
an injection apparatus having a longitudinally fixed roller.
[0067] FIG. 28 is a schematic perspective view of another
embodiment of an injection apparatus having a longitudinally fixed
roller.
[0068] FIG. 29 is a schematic perspective view of another
embodiment of an injection apparatus having a longitudinally fixed
roller.
[0069] FIG. 30 is a schematic perspective view of another
embodiment of an injection apparatus having a longitudinally fixed
roller.
[0070] FIGS. 31A and 31B schematically show two positions of an
alternative pump apparatus including an inflatable balloon
pump.
[0071] FIGS. 32A and 32B schematically show two positions of an
alternative pump apparatus including a pair of magnets on opposite
sides of the flexible container.
[0072] FIGS. 33A and 33B schematically show two positions of an
alternative pump apparatus including an electromagnet and a
magnetically attracted mass.
[0073] FIGS. 34A and 34B schematically show two positions of an
alternative pump apparatus including a source of fluid pressure
communicated with the interior of the flexible container.
[0074] FIG. 35 is a plan view of a cartridge contained in secondary
packaging.
[0075] FIG. 36 is a side view of the packaging of FIG. 35.
[0076] FIG. 37 is a section view taken along line 37-37 of FIG.
35.
[0077] FIG. 38 is a plan view of a cartridge in another embodiment
of secondary packaging.
[0078] FIG. 39 shows the packaging of FIG. 38 with a cover peeled
back.
[0079] FIG. 40 is a side view of the packaging of FIG. 39.
[0080] FIG. 41 is a plan view of a single use injector device
contained in secondary packaging.
[0081] FIG. 42 is a plan view of a single use device having a
transparent window covered by a pull strip.
[0082] FIG. 43 shows the device of FIG. 42 after the pull strip has
been pulled to expose the cartridge through the transparent
window.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
The Embodiment of FIGS. 1A-1D
[0083] FIGS. 1A-1D schematically illustrate one embodiment of an
auto-injector apparatus.
[0084] FIG. 1A schematically illustrates a step in the assembly of
an auto-injector apparatus 10, a more complete assembly of which is
shown in FIG. 1B. In FIG. 1A, a needle sub-assembly 12 is laid in
place upon a flat portion of a flexible substrate 14.
[0085] The flexible substrate 14 begins as a flat flexible sheet of
material which may for example be a polymer material and may
include a laminated metal layer as further described below. A drug
containment volume 16, which may also be referred to as a flexible
container 16, has been formed in a blister manner into the flat
flexible sheet. Also formed into the sheet are a necked down
passage 18, a manifold portion 20, and a bleed vent 22.
[0086] In FIG. 1B, the substrate 14 has been folded over about a
fold line 24 and the flat portions of the flexible substrate have
been sealed together where they engage. Also, the necked down
passage 18, which may also be referred to as neck 18, has been
sealed to isolate needle 26 and close the drug containment volume
16 at its proximal end.
[0087] It is noted that in this description, the term "proximal" is
used to refer to the end of the apparatus that is closest to or
engaged with the patient when the apparatus is in use to inject the
medicant into the patient's body. Thus the sharp end 28 of the
needle 26 is referred to as the proximal end of needle 26.
Similarly, the proximal end of the apparatus 10 is indicated at 30.
Accordingly the distal end of the apparatus 10 is indicated at
32.
[0088] After the substrate 14 has been folded over and the flat
portions and the neck 18 have been sealed, the drug containment
volume 16 is filled with a drug or medicant which is placed through
the top end 34 of the still open drug containment volume 16, then
the top end is closed or sealed as indicated at 36 in FIG. 1B.
[0089] Then, the volume of the drug containment volume 16 is
compressed slightly to expel residual air through the bleed feature
22 after which a neck 38 of the bleed feature 22 is sealed to
completely seal the drug containment volume 16.
[0090] Then the back side of the substrate 14 adjacent the drug
containment volume 16 is bonded to an unrolled coil spring strip 40
also sometimes referred to as a Tensator spring 40.
[0091] FIGS. 1C and 1D schematically illustrate two steps in the
use of the apparatus 10. In FIG. 1C, the actuation of the apparatus
10 has begun, and the drug containment volume 16 and needle
sub-assembly 12 including needle 26 have moved axially forward in a
proximal direction forcing the needle 26 to protrude through the
front 42 of the substrate material 14 with excess material bunching
as indicated at 44 near the root of the needle 26. It will be
understood that this step in the actuation, and the proximal
movement of the drug containment volume and needle sub-assembly 12
is accomplished by means of an actuating mechanism which is not
shown in FIGS. 1A-1D.
[0092] In FIG. 1D, the coil spring strip 40 has been released and
has rolled forward proximally into its natural coiled state. As the
loop of the coil spring strip 40 rolls forward, it compresses the
flexible drug containment volume 16 and expresses the drug
contained therein through the passage 18 and through the needle 26
into the patient. The loop may be described as an integral roller
portion 41 of the coil spring strip 40.
[0093] Several features are provided by the integrated assembly of
the apparatus 10 shown in FIGS. 1A-1D.
[0094] The apparatus 10 provides drug containment in the flexible
container defined by the drug containment volume 16 and the
surrounding flexible substrate 14.
[0095] The properties of the material selected for the substrate 14
which forms the flexible barrier around the drug containment volume
16 may be selected as appropriate.
[0096] The folded substrate material about the needle sub-assembly
12 as seen in FIG. 1D provides needle sterility until the point of
use of the apparatus 10.
[0097] The frangible seal provided at neck 18 provides a dry needle
in storage.
[0098] The bleed feature 22 provides a means of air removal during
filling.
[0099] The potential is provided for having two of the drug
compartments 16 formed in the substrate 14 which provides a
lyophilized powder option, as is for example further discussed
below with regard to FIG. 26D.
[0100] The apparatus 10 allows for flexible fill volumes by
selection of the size of the drug containment volume 16 formed in
the substrate 14.
[0101] The use of a roller to express the drug from the flexible
volume 16 allows full delivery of contents from the volume 16
through the needle 26.
[0102] The apparatus 10 is compact in size and relatively low in
cost.
[0103] The apparatus 10 aids convenience in injecting drugs by
simplifying the drug injection process by inserting the needle into
the delivery site, delivering the drug and subsequently sheathing
the needle with minimal user input.
[0104] As best seen in FIG. 1A, the needle sub-assembly 12 includes
a needle hub 46 which as shown in FIG. 1B is structurally connected
to the flexible container 16 via the folded layers of the substrate
14, and is fluidly connected to the interior of container 16 via
the passage 18 and the manifold portion 20 which communicate with
an opening (not shown) in the needle hub 46 which in turn
communicates with the needle 26.
[0105] The needle 26 is attached to the needle hub 46 and extends
proximally from the needle hub 46. A needle protection frame 48 is
connected to the needle hub 46. The frame 48 includes first and
second transversely spaced frame arms 50 and 52 which are supported
from the needle hub 46 on opposite sides of the needle 26 and
extend proximally beyond the proximal end 28 of needle 26.
Laterally inward extending supports 54 and 56 are defined on the
proximal ends of arms 50 and 52, respectively, to aid in supporting
the folded over substrate 14 as seen in FIG. 1B. The arms 50 and 52
hold the front 42 of substrate material 14 away from proximal end
28 of needle 26.
[0106] When the container 16, needle hub 46 and needle 26 move
proximally forward from the position of FIG. 1B to the position of
FIG. 1C relative to the front 42 of laminated substrate 14, the
frame arms 50 and 52 fold up in an accordion like manner as shown
in FIG. 1C to allow the relative movement between needle 26 and the
front 42 of the laminate 14. The needle hub 46 and the needle 26
may be described as being displaceable relative to the frame 48 in
a proximal direction to insert the needle 26 into a patient.
[0107] Those portions of the laminated material 14 folded over the
needle 26 between the arms 50 and 52 as seen in FIG. 1B may be
referred to as a flexible needle pouch 58 connected to the frame 48
and covering the needle 26 to maintain the needle 26 in a sterile
condition prior to use. As illustrated, the pouch 58 is collapsible
so that the needle 26 can protrude through the pouch 58 upon
proximal displacement of the needle hub 46 and needle 26 relative
to the frame 48.
[0108] The two sheets of the substrate 14 forming the needle pouch
58 can be described as a sheet of flexible material 14 folded at
fold 24 into two sheet portions joined together along at least two
sides as indicated at 60 and 62, the two sides 60 and 62 extending
generally parallel to the needle 26 which may be described as being
transverse to the fold 24.
[0109] The flexible container 16 may be described as being made up
of first and second layers of the flexible substrate material 14
joined together to define a container space 16 therebetween, the
first and second layers of the substrate 14 further defining the
passages 18 and 20 communicating the container space 16 with the
needle hub 46.
[0110] As previously noted, the necked down portion 18 of the
passage is temporarily closed to provide a frangible seal
temporarily closing the passage 18 to isolate the needle 26 from
medicant in the volume 16. That frangible seal is formed by joining
portions of the first and second layers of the substrate 14 so that
they are lightly sealed together across the passage 18 thus
blocking the passage 18 until the pressure within the container 16
is sufficient to break that seal across the neck down portion 18 by
causing the two layers to peel away from each other.
[0111] The flexible container 16 may also be described as
comprising first and second layers of the flexible substrate 14,
which may be described as a flexible film 14, joined together
around at least part of a containment perimeter so that the
interior volume of container 16 is a containment space defined
between unjoined portions of the first and second layers of the
substrate 14. As is apparent in FIGS. 1B and 1C, the container or
containment space 16 is an elongated space having a length 64
extending generally parallel to a proximal/distal axis 66 of the
container 16, and having a width 68 transverse to and less than the
length 64, so that the containment space 16 has two lengthwise
sides 63 and 65 parallel to length 64, a distal side 70 and a
proximal side 72. The first and second layers of the substrate
material 14 are joined together on at least the two lengthwise
sides 63 and 65 and the distal side 70, and the two layers of
substrate 14 are further joined together to define the passages 18
and 20 communicating the proximal side 72 of the containment space
16 with the needle hub 46.
[0112] The coil spring strip 40 may be described as a drive spring
40 having its integral roller portion 41 which rolls over the
flexible container 16 after the needle 26 is extended to the
position shown in FIGS. 1C and 1D.
The Embodiment of the Multi-Use Apparatus of FIGS. 2-24
[0113] FIGS. 2A-2G comprise a sequential series of illustrations
showing the manner of usage of a multi-use auto-injector apparatus
which is generally designated by the numeral 100. The apparatus 100
includes a housing 102 having a lid 104 which may be opened as
indicated in FIGS. 2B and 2C to allow removal and replacement of a
cartridge assembly 106.
The Cartridge Assembly
[0114] The details of construction of the cartridge assembly 106
are seen in FIGS. 3-9. FIG. 3 is a proximal end view of the
cartridge assembly 106. FIG. 4 is a right side elevation view of
the cartridge assembly 106. FIG. 5 is a bottom view of the
cartridge assembly 106. FIG. 6 is a top plan view of the cartridge
assembly 106. FIG. 7 is a perspective exploded view showing the
components of the cartridge assembly 106. FIGS. 8A and 8B show the
cartridge assembly in two different operating positions.
[0115] The cartridge assembly 106 includes a flexible container 108
that as schematically illustrated in FIG. 7 includes a liquid
medicant 110. As best seen in FIG. 7, the flexible container 108
comprises first and second layers 112 and 114 of flexible film
joined together. As shown in FIG. 6, the layers 112 and 114 of film
are joined together around at least a part of a containment
perimeter defined by two lengthwise sides 116 and 118, a distal
side 120 and a proximal side 122. The interior of flexible
container 108 may be described as a containment space which is
defined between unjoined portions of the first and second layers
112 and 114. That containment space is an elongated space having a
length 124 extending generally parallel to a proximal/distal axis
128 of the container 108, and having a width 130 transverse to and
less than the length 124, so that the containment space within
container 108 has the two lengthwise sides 116 and 118 mentioned
plus the distal side 120 and the proximal side 122.
[0116] The first and second layers 112 and 114 are joined together
along the two lengthwise sides 116 and 118 in the areas as
indicated at 132 and 134, and along the distal side 122 in the area
as indicated at 136.
[0117] The upper layer of film 112 has a manifold portion 138
formed therein as best seen in FIG. 7. The manifold portion 138 is
shaped so as to closely fit over a distal portion of a central hub
portion 146 of a needle hub 140. The needle hub 140 includes the
central hub portion 146 and upper and lower hub clamps 148 and 150.
The upper and lower hub clamp portions 148 and 150 have slots such
as 176 therein for receiving positioning ribs such as 178 of
central hub 146 therein. The upper and lower clamp portions 148 and
150 are held together by flexible arms such as 180 having laterally
inward extending protrusions such as 182 which snap fit below
ledges such as 184 on the fewer clamp part 150.
[0118] As generally indicated by the dotted line 142 in FIG. 6, a
passage 142 communicates the interior of the container 108 with the
manifold portion 138 and thus with the needle hub 140. After the
container space within the flexible container 108 has been filled
with the medicant 110, the passage 142 is temporarily sealed by a
frangible seal 143 which is formed by pressing the first and second
layers 112 and 114 of flexible film together and lightly sealing
the two together across the passage 142 so as to temporarily seal
the medicant within the flexible container 108. As is further
described below, during use of the apparatus 106 a roller will roll
across the flexible container 108 from its distal end 120 toward
its proximal end 122 and the pressure within the flexible container
108 will break the seal 143 by causing the layers 112 and 114 to
peel apart within the area of the passage 142 thus allowing the
liquid medicant to flow from the container 108 through the passage
142 and through the central hub portion 146 of needle hub 140 to a
needle 144.
[0119] The hub 140 and needle 144 are part of a needle subassembly
152 which further includes a needle protection frame 154 connected
to the needle hub 140 and including a frame proximal end 156
extending proximally beyond a proximal end 158 of needle 144. As is
apparent in viewing FIGS. 8A and 8B, the needle hub 140 and needle
144 are displaceable relative to the frame 154 in a proximal
direction to insert the needle 144 into a patient.
[0120] The needle protection frame 154 includes first and second
transversely spaced frame arms 158 and 160 supported from the
needle hub 140 on opposite sides of the needle 144 and extending
proximally beyond the proximal end 158 of needle 144.
[0121] The frame 154 further includes a front bar 162 made up of
upper and lower front clamp halves 164 and 166, spanning between
the proximal ends of the frame arms 158 and 160 to protect the
proximal end 158 of the needle 144 when the needle 144 is in an
initial position corresponding to FIGS. 4-6 and FIG. 8A. The upper
and lower front clamp portions 164 and 166 are held together by
flexible arms such as 185 on the upper clamp portion having
laterally inward extending protrusion 188. As best seen in FIG. 3,
the front bar clamp portions have recesses defined therein which
form an opening 168 through the front bar 162 through which the
needle 144 passes when the needle moves proximally relative to the
frame 154 to insert the needle into a patient. Such proximal
movement is illustrated in the position of FIG. 8B wherein the
needle 144 has passed through the opening 168.
[0122] The upper hub clamp 148 of needle hub 140 includes first and
second cylindrical openings 169 and 171 defined therethrough within
which are slidably received the cylindrical arms 158 and 160,
respectively,
[0123] As best seen in comparing FIGS. 8A and 8B, the frame arms
158 and 160 slide through the openings 169 and 171 of needle hub
140 when the needle hub 140 and needle 144 are displaced proximally
relative to the frame 154 to insert the needle 144 into a
patient.
[0124] The needle sub-assembly 152 preferably includes a flexible
needle pouch 170 connected to or supported from the frame 154 and
covering the needle 144 to maintain the needle 144 in a sterile
condition prior to use. The needle pouch 170 is collapsible so that
the needle 144 can protrude through the pouch 170 upon proximal
displacement of the needle hub 140 and needle 144 relative to the
frame 154 as illustrated in FIG. 8B. The flexible needle pouch 170
is preferably formed from two sheets of flexible film in a manner
similar to that described for formation of the flexible container
108 from the two sheets 112 and 114. The needle pouch 170 has an
opening 172 at a distal end portion that is similar in size and
shape to the opening or manifold portion 138 described above, which
opening 172 closely fits over a proximal portion 174 of the central
hub 146. Needle pouch 170 may be formed from a sheet of flexible
material folded at a fold line 186 into two sheet portions joined
together along at least two sides transverse to the fold.
[0125] The sheets 112 and 114 are preferably joined together by
welding of the sheet material. The welding may be accomplished by
application of heat, by application of radio frequency energy, by
application of ultrasonic energy, by friction welding, or any other
suitable welding technique. Alternatively the sheets can be joined
by solvent bonding or the use of any other suitable adhesive. The
central hub 146 is preferably formed of plastic and is preferably
joined to the flexible container 108 and to the needle pouch 170 by
welding of the flexible material to the central hub 148.
[0126] In any of the embodiments disclosed herein wherein two
separate sheets are joined together, such as sheets 112 and 114, an
equivalent structure may be provided by folding a single sheet.
Similarly, in any of the embodiments disclosed herein wherein a
single sheet is folded to form two overlying layers, an equivalent
structure may be provided by two separate sheets joined
together.
[0127] Also, instead of using a needle pouch 170 constructed from
two sheets or a folded sheet of flexible material, a formed
cylindrical rubber or plastic sheath or nipple may be used and
directly attached to needle hub 140.
[0128] FIGS. 9A-9C illustrate the operation of a releasable lock
188 operably associated with the frame arms 158 and 160 and the
needle hub 140. The releasable lock 188 can lock the needle
protection frame 154 in the locked position as shown in FIG. 9A
wherein the frame arms 158 and 160 are prevented from sliding
distally relative to the needle hub 140, and an unlocked position
as illustrated in FIGS. 9B and 9C, wherein the needle protection
frame 154 is allowed to slide distally relative to the needle hub
140. The releasable lock 188 includes resilient locking arms 190
and 192 which is their unbiased position as shown in FIG. 9A are
received in notches such as indicated at 194 in the distal ends of
the arms 158 and 160. When the flexible arms 190 and 192 are
received in the notches 194 they prevent the arms 158 and 160 from
sliding distally through the needle hub 140.
[0129] Referring back to the series of FIGS. 2A-2G, when the lid
104 is returned to a closed position as shown in FIG. 2D a pair of
pins (not shown) on the underside of the lid 194 engage the
flexible arms 190 and 192 and push them downward as indicated by
arrows 196 and 198 in FIG. 9B so as to permit the arms 158 and 160
to slide distally shown in FIG. 9C.
[0130] The flexible materials making up the first and second layers
112 and 114 of film which are used to make the flexible container
108 may be selected based upon numerous desirable properties for
the flexible container 108. For example, the flexible container 108
may be constructed from a transparent or translucent material so
that an extent to which the container 108 is filled with medicant
can be observed by the user. Also, the materials from which the
container 108 is manufactured may be selected based upon their
properties as oxygen and moisture barriers for protection and shelf
life of the medicant contained in the container 108. One preferred
such material which will be opaque and will provide very high
barrier properties is a flexible metallic material which includes
an aluminum lamination. Other metallic films, layers or foils could
also be used. For example a metallic layer could be vacuum
deposited upon an underlying flexible substrate.
[0131] Numerous examples of possible flexible materials from which
the first and second layers 112 and 114 of film may be selected are
set forth in the following Table I along with some approximate
properties of these materials as oxygen and moisture barriers. In
each case the product is described as a lamination of three
materials.
TABLE-US-00001 TABLE I Total Thick- Oxygen Barrier Moisture Barrier
ness (1 ml. volume) (1 ml. volume) Product .mu.m (g/m.sup.2/day)
ppm (cc/m.sup.2/day) ppm PP/20.mu. EVOH/PP 160 1.86 1897 0.2 204
PP/40.mu. EVOH/PP 160 1.93 1969 0.1 102 PP/PET.cndot.SIOx/PP 112
0.5 510 0.5 510 PP/23.mu. PCTFE/PP 100 0.23 235 120 122400
PP/51.mu. PCTFE/PP 100 0.11 112 55 56100 PP/PET.cndot.SIOx/PP 112
0.001 1 0.001 1 (Super) Lacquer/Aluminum/ 110 0 0 0 0 PP
[0132] The abbreviations for the products in the first column of
Table I refer to the following materials: [0133] 1. PP is
polypropylene. [0134] 2. PCTFE is polychlorotrifluoroethylene.
Polychlorotrifluoroethylene is a fluoropolymer that has the best
water barrier properties of all suggested polymers. It is also
known under the trademark ALCAR.RTM., which is a product of
Honeywell. [0135] 3. EVOH is ethylene vinyl alcohol. Ethylene vinyl
alcohol is a polymer that has outstanding oxygen barrier
properties, but is prone to moisture transmission and therefore
must be all protected by outer layers. [0136] 4. SIOx is silicium
oxide. It is a very thin glass layer coated onto a PET film. The
coating process can be achieved in many different ways.
[0137] The use of a transparent or translucent drug containment
film may be suitable for drugs that have low dissolved oxygen and
low loss of moisture stability requirements. It has the advantage
that visual inspection of the drug at time of manufacture and by
the patient before injection is possible. The disadvantage is
potential susceptibility to ultraviolet radiation. Many of the
polymers listed in Table I may be obtained in a sufficiently
transparent form that the level of the liquid medicant in the
container can be visualized, although they may not be fully
transparent.
[0138] For drugs that have higher dissolved oxygen and low loss of
moisture stability requirements, an opaque containment film
including a foil layer within the film, such as aluminum foil, may
be desirable. Such a configuration has the advantage of less
susceptibility to ultraviolet radiation. It has the disadvantage
that visual inspection of the drug at time of manufacture and by
the patient before injection may not be possible.
External Packaging:
[0139] Another option is to utilize a transparent flexible drug
containment film which is sealed inside metal foil secondary
packaging. This option is suitable for drugs that have high
dissolved oxygen and low loss of moisture stability requirements.
It has the advantage that visual inspection of the drug at the time
of manufacture and by the patient before the injection is possible,
and that it is less susceptible to ultraviolet. This solution may
also be suitable for drugs that have very high stability
requirements, i.e. if the secondary packaging is sealed under
nitrogen or contains an oxygen absorbing material. Such an
embodiment is shown for example in FIGS. 35-37 wherein the
cartridge 106 is shown in place within a foil package 700. The
package 700 is made from a bottom layer 702 and a top layer 704
sealed together around their periphery. Top layer 704 is raised as
best seen in FIGS. 36 and 37 to create an interior space 710 for
storage of the cartridge 106. Notches 706 and 708 are preformed in
the package 700 so that it may be torn apart across the width of
the package so that the cartridge 106 may be removed for use. The
package 700 is preferably made of a metal foil material which will
be impermeable to moisture and air. As noted the interior 710 of
the package may be sealed under nitrogen or contain an oxygen
absorbing material. The flexible container 108 will be made of
transparent material so that when it is manufactured, and when it
is removed from package 700 for use, it may be visually inspected
to insure that it is filled with medicant and that the medicant is
clear and contains no particulates.
[0140] Another form of external packaging is shown in FIGS. 38-40.
In this case the cartridge 106 is contained in an opaque package
720, which again is preferably constructed from a metal foil
material such as aluminum. Package 720 is made from a bottom layer
722 and a top layer 724 joined around their periphery to define an
interior 726. A window 728 is defined in top layer 724 and is
initially covered by a peelable strip 730 as shown in FIG. 38. As
shown in FIGS. 39 and 40 the strip 730 is peeled back so that the
cartridge 106 is visible and can be removed from the packaging.
Alternatively the entire top layer can be designed to be peeled
back from the bottom layer.
[0141] Both of the packaging embodiments 700 and 720 just described
are intended for packaging of cartridges for use in multi-use
injector devices as further described below. Other external
packaging arrangements for single use injector devices are
described below with regard to FIGS. 41-43.
Container Shapes:
[0142] The shape and dimensions of the flexible container 108 may
be selected based upon various considerations. Several alternatives
are shown in FIGS. 26A-26H, and it will be understood that due to
the design flexibility provided by the use of molding the flexible
film to construct the flexible container 108, any desired shape can
be readily formed and utilized with the apparatus 100.
[0143] For example, FIGS. 26A and 26B show how the volume of liquid
medicant contained in the flexible container 108 may be readily
changed simply by forming the container 108 to have a smaller
volume. The container 108 in the embodiment of FIG. 26B has a
volume approximately ten times that of the container 108 in the
embodiment of FIG. 26A.
[0144] The embodiment of FIG. 26C includes two flexible containers
108' and 108'' in a parallel relationship, both of which are
communicated with the needle hub 140 through frangible seals such
as the frangible seal 143 described above, thus permitting the
mixing of two liquid drugs during the injection process.
[0145] The embodiment of FIG. 26D includes two flexible containers
108' and 108'' in series. The first container 108' is separated
from the second container 108'' by a first frangible seal 143'. The
second container 108'' is separated from the needle hub 140 by a
second frangible seal 143''. The first container 108' is filled
with a liquid drug component and the second container 108'' is
filled with a dry drug component. As the roller 210 rolls forward
it first pressurizes first container 108' to burst first frangible
seal 143' so that the liquid component flows into the second
container 108'' and begins to mix with the dry drug component. As
the roller 210 continues to roll forward the second frangible seal
143'' bursts and the mixed liquid and dry drug components are
expelled through the needle.
[0146] The embodiments of FIGS. 26E-26H show profiled containers
108 which affect the flow rate of delivery of drug from the
container 108 as the mechanism rolls a roller across the container
to squeeze the medicant out of the container.
[0147] In the embodiments of FIGS. 26E-26H the roller 210 is
positioned to engage the flexible container 108 and expel the
medicant from the container upon relative movement between the
roller 210 and container 108 in a displacement direction 211 shown
in FIG. 26E. Displacement direction 211 is a longitudinal direction
parallel to the axis 128 of cartridge 106. The roller 210 has a
rotational axis 213 transverse to that displacement direction
211.
[0148] In the embodiment shown in FIG. 26E the flexible container
108 has a width 130 transverse to the displacement direction 211,
the width 130 varying along the displacement direction. The roller
210 first engages the container at a first position shown in solid
lines and roller 210 moves in the displacement direction toward a
second position shown in dotted lines. In the embodiments of FIGS.
26E and 26G, the width 130 of the container 108 at the second
engagement position of roller 210 shown in dashed lines is less
than the width of the container at the first engagement position,
so that the speed of injection of medicant decreases during
relative movement of the roller 210 between the first and second
engagement positions. This assumes that the roller 210 moves at a
constant speed in direction 211. In the embodiments of FIGS. 26E
and 26G the width 130 of the container continuously decreases from
the first engagement position to the second position.
[0149] Conversely, in the embodiment of FIG. 26F, the width of the
container 108 at the second engagement position of the roller 210
shown in dashed lines is greater than the width of the container at
the first engagement position of the roller shown in solid lines,
so that a speed of injection of medicant increases during the
relative movement of the roller 210 between the first and second
engagement positions.
[0150] Finally, as shown in FIG. 26H, the width 130 of the
container 108 can vary in multiple aspects. In the embodiment of
FIG. 26H, the width 130 first decreases, then increases, which
provides an alternating injection speed which first decreases and
then increases.
[0151] It will be appreciated that the profile of the flexible
container can be designed so as to provide any desired changing
injection speed profile.
The Multi-Use Dispensing Device
[0152] The details of construction of those portions of the
apparatus 100 other than the cartridge assembly 106 are best shown
in FIGS. 10-24. It will be understood that the multi-use apparatus
of FIGS. 10-24 and the single use apparatus of FIG. 25 are shown in
schematic form in order to illustrate and describe the major
internal working components of the device. Further details of the
apparatus 100 are explained below with regard to external features
of the apparatus 100 which are better shown in the series of FIGS.
2A-2G.
[0153] The basic components of the apparatus 100 are most easily
understood by viewing the exploded view of FIG. 10. The housing
102, which may be referred to as a main housing body has a housing
interior 202 and an opening 204. The lid 104 is pivotally attached
to the main housing body 102 and is moveable between a closed
position as shown in FIG. 11 closing the opening 204 and an open
position as shown in FIG. 13 wherein the housing interior 202 is
accessible through the opening 204.
[0154] The apparatus 100 includes a container carriage 206 which is
reciprocably disposed in the housing body 102. As is illustrated
and further described with regard to FIGS. 15 and 16 below, the
cartridge assembly 106 including the flexible container 108 will be
received in the carriage 206 so that the carriage 206, the
container 108 and the needle 144 are moveable together within the
housing 102 between a first carriage position illustrated in FIGS.
18, 18A-A and 18B-B and a second carriage position illustrated in
FIGS. 20, 20A-A and 20B-B, corresponding to first and second
positions of the needle 144, respectively.
[0155] A needle return chassis 208 cooperates with the container
carriage 206 and is also reciprocably disposed in the housing 102
to aid in withdrawing the needle from its extended position as in
FIG. 21 to a retracted safety position as illustrated in FIGS. 23,
24, 24A-A and 24B-B.
[0156] A roller 210 includes axles such as 212 extending from each
end thereof which extend through roller tracks or slots 214 and 216
defined in the container carriage 206 so as to guide the roller 210
as it rolls in a proximal direction relative to the container
carriage 206 to expel medicant from the container 108 as will be
further described below.
[0157] A roller cam 218 has an opening 220 through which the axle
212 extends. The cam 218 is mounted on the outside of the slot 214.
Cam 218 includes a mounting pin 219 which extends through a bore
222 in a spool 224 attached to a main drive spring 226. The main
drive spring 226 is a soil spring strip which has a first end 228
fixed to the main housing body 102, and a second end portion 230
which coils around the spool 224 as the main drive spring 226
contracts to its relaxed position. The coil strip spring 226 may
provide a substantially constant spring force, and thus may be
referred to as a constant force spring. When the main drive spring
226 is uncoiled or extended as shown in FIG. 10 it stores potential
energy which is utilized to drive the container carriage 206
proximally to insert the needle 144 into a patient's body and to
subsequently drive the roller 210 proximally through the container
carriage 206 to roll over the flexible container 108 to expel the
medicant therefrom. The main drive spring 226 may be described as
being operably associated with the container carriage 206, and thus
with the needle 144 attached to the container 108 carried in the
container carriage 206, so as to extend the needle 144 from a first
needle position as shown for example in FIG. 18A-A wherein the
needle 144 is completely received in the housing 102, to a second
needle position as shown for example in FIG. 20A-A wherein the
needle 144 protrudes from the housing 102.
[0158] The main drive spring 226 may also be described as being
operably associated with the roller 210 to roll the roller 210 over
the flexible container 108 after the needle 144 is extended to its
second needle position. As is further explained below with regard
to FIGS. 31-34, the roller 210 may be more generally described as a
pump 210, and other alternative pump structures may foe used in
other embodiments.
[0159] The roller cam 218 may be further described as a roller
interlock between the roller 210 and the container carriage 206 to
prevent the roller 210 from rolling over the flexible container 108
until after the main drive spring 226 moves the needle 144 to its
second needle position.
[0160] As will be further described below with regard to FIG.
14A-A, when the lid 104 is opened the roller cam 218 is forced
downwardly against the distal end of the container carriage 206 by
a ramp 232 on the outer body 102. Thus the roller cam 218 will
prevent the roller 210 from rolling proximally relative to the
container carriage 206 until after the container carriage 206 has
moved proximally to its second container carriage position as shown
for example in FIG. 20A-A.
[0161] A retraction spring 234 has a first end 236 connected to a
post 238 on the needle return chassis 208 and a second end 240
connected to a post 242 fixed to the bottom floor of the main
housing body 102. As is further explained below the retraction
spring 234 will, at an appropriate time, pull the needle return
chassis 208 and the container carriage 206 and the container 108
and the needle 144 back in a distal direction to withdraw the
needle 144 after the medicant has been expelled from the flexible
container 108.
[0162] The apparatus 100 further includes a cocking linkage 244
connecting the lid 104 to the main drive spring 226 and the
retraction spring 234 so that opening of the lid 104 extends the
main drive spring 226 and the retraction spring 234. The cocking
linkage 244 includes a number of components including gears 246 and
248 integrally formed on the distal end of the lid 104, a main
drive rack 250, a drive gear 252, and a spring rack 254. The drive
gear 252 includes integrally attached smaller gear 253 and larger
gear 255. The drive gear 252 is mounted on an axle 257 extending
laterally from the container carriage 206. Thus the drive gear 252
moves laterally with the container carriage 206 within the main
housing 102. In the position illustrated in FIG. 10, the small gear
253 is engaged with the gear teeth of the main drive rack 250, and
the larger gear 255 is engaged with the gear teeth of the spring
rack 254. As is further described below, upon actuation of a
trigger 270 the spring rack 254 is shifted laterally relative to
drive gear 252 out of engagement with the gear teeth of larger gear
255.
[0163] Turning now to FIGS. 11-24 various operating positions of
the apparatus 100 are illustrated.
[0164] When the apparatus 100 is in the position represented by
FIGS. 11, 12, 12A-A and 12B-B, the apparatus 100 is in an unprimed
state after a previous injection. For ease of illustration, in
views 12A-A and 12B-B no cartridge 106 is shown within the housing,
although there would typically be a spent cartridge in place after
use of the apparatus 100.
[0165] In this position the needle return chassis 208 has moved
distally until it abuts a distal end 209 of the housing 102. That
movement is accomplished by the needle return spring 234. The
container carriage 206 is also in its distalmost position to which
it was carried by engagement of lateral tabs such as 256 and 258
(see FIG. 10) defined on needle return chassis 208 with vertical
tabs such as 260 extending downward from container carriage 206. In
the position of container carriage 206 shown in FIG. 12A-A the main
drive spring 234, which for ease of illustration is not shown in
FIGS. 12A-A or 12B-B, is in a partially extended position to which
it has been carried by contraction of the return spring 234. As
shown in FIG. 12B-B the roller 210 is in a proximalmost position
relative to container carriage 206 to which position the roller 210
rolled during the prior actuation of the apparatus 100.
[0166] Moving now from the position of FIGS. 11 and 12 to the
position of FIGS. 13 and 14, when the user opens the apparatus 100
by lifting the lid 104 from the body 102 the main drive rack 250 is
driven forward or proximally thus forcing the needle return chassis
208 forward due to engagement of a cross bar 262 of main drive rack
250 with a downward extending foot 264 of needle return chassis
208. This extends the needle retraction spring 234. A first trigger
266 shown schematically in FIG. 14A-A will engage the needle return
chassis 208 to prevent the chassis 208 from moving rearwardly or
distally after the retraction spring 234 has been stretched to full
extension as shown in FIG. 14A-A.
[0167] Furthermore, in the position of FIG. 14A-A the roller 210
has been forced to its distalmost position wherein the roller cam
218 has engaged the ramp 232 and has moved downward to hold the
roller 210 in its distalmost position relative to the container
carriage 206. When the roller 210 is forced distally this also
serves to extend the main drive spring 226. These movements have
been accomplished by the cocking linkage 244 upon opening of the
lid 104 in the following manner. As the lid 104 pivots upwardly
away from the main housing body 102 the gears 246 and 248 which are
meshed with the teeth of the main drive rack 250 force the main
drive rack 250 to move proximally within the housing 102. As the
main drive rack 250 moves in a proximal direction, it rotates the
drive gear 252 which is rotatably mounted on axle 257 (see FIG. 10)
of container carriage 206. As the drive gear 252 rotates, its
larger gear member is in engagement with the spring rack 254 which
drives the spring rack 254 in the opposite direction from the main
drive rack 250. Thus the spring rack 254 moves in a distal
direction and its distal end 268 is engaged with the coil portion
230 of main drive spring 226 and moves the coil portion 230
distally thus unwinding and stretching or extending the main drive
spring 226.
[0168] A second trigger 270 schematically illustrated in FIG. 14B-B
prevents the container carriage 206 from moving forward or
proximally.
[0169] With the apparatus 100 in the open position as shown in FIG.
13, a cartridge assembly 106 can be placed therein as illustrated
in FIG. 15.
[0170] Then as shown in FIGS. 17 and 18, the lid 104 is closed and
the apparatus 100 is now primed and ready for use. As shown in
FIGS. 18A-A and 18B-B, closing the lid 104 returns the main drive
rack 250 to its distalmost position leaving the needle return
chassis 208 in its cocked or primed position. As previously noted
the needle return chassis is held in position by first trigger
266.
[0171] Next, a proximal end 272 of the apparatus 100 is held
against the patient's body and second trigger 270 is fired manually
to shift the spring rack 254 sideways thus demeshing the spring
rack 254 from the drive gear 252. This releases the container
carriage 206 so that the container carriage 206 is driven forward
or proximally by the main drive spring 226. The container carriage
206 carries with it the container 108 and the needle hub 140 and
needle 144. The needle 144 is driven forward or proximally to the
position shown in FIGS. 19 and 20. During that movement, the needle
protection frame 154 of cartridge assembly 106 has remained fixed
relative to the housing 102 while the needle hub 140 slides
proximally over the arms 158 and 160 to a position like that shown
in FIG. 8B.
[0172] Thus as the apparatus 100 moves from its position as
illustrated by FIGS. 17 and 18 to its position as illustrated by
FIGS. 19 and 20, the needle hub 140 and needle protection frame 154
move relatively between their positions as shown in FIG. 8A to
their position as shown in FIG. 8B.
[0173] It is noted that in FIG. 20, the roller 210 still has not
moved forward within the container carriage 206, because the roller
cam 218 has held the roller 210 in place.
[0174] As the container carriage 206 moves forward the roller cam
218 reaches the end stop on a ramp 219 (see FIG. 10) on the outer
body 102 which forces the roller cam 218 upward thus releasing the
roller 210 and allowing the roller 210 to move proximally along the
tracks 214 and 216 thus rolling over the flexible container 108 to
expel the medicant therefrom. The roller 210 moves from its
position as shown in FIG. 20B-B to its position as shown in FIG.
22B-B. The roller 210 is driven forward or proximally relative to
the container carriage 206 by the further contraction of the main
drive spring 226. When the roller 210 reaches its forwardmost
position as shown in FIG. 22B it trips trigger 266 thus releasing
the needle return chassis 208 which is then drawn backward or
distally due to contraction of the retraction spring 234 thus
pulling the needle return chassis 208 and the container carriage
206 along with the cartridge assembly 106 and the needle 144 back
to their starting positions as shown in FIGS. 23 and 24 wherein the
needle 144 is once again withdrawn to a safety position within the
housing 202.
[0175] During that return motion, the main drive spring 226 is
partially extended when the container carriage 206 pulls back the
roller 210 from the position shown in FIG. 22B-B to the position
shown in FIG. 24B-B. The apparatus 100 in FIGS. 23 and 24 is now
back in the same position at which it began in FIGS. 11 and 12.
[0176] The first trigger 266 may be described as an interlock 266
operably associated with the needle return chassis 208 and the
container carriage 206. The interlock 266 releases the needle
return chassis 208 after the roller 210 expels the medicant from
the container 108 so that the retraction spring 234 can withdraw
the needle return chassis 208, the container carriage 206, the
container 108 and the needle 144 to a safety position wherein the
needle 144 is fully received back in the housing.
[0177] Thus, the apparatus 100 is in condition to again be opened
and have the cartridge assembly 106 replaced. Thus the apparatus
100 is a multi-use apparatus which can be used any number of times
by replacing the cartridge 106 after use.
[0178] When the cartridge 106 is placed in the container carriage
206 two openings 274 and 276 (see FIG. 5) in the needle hub 140
receive two posts 278 and 280 (see FIG. 10) extending upward from
the container carriage 206. A wall 282 of container carriage 206
engages a wall 284 (see FIG. 5) of needle hub 140. When the
cartridge 106 is in place in the apparatus 100 the front bar 162 of
cartridge 106 is closely received in recesses 105 and 107 of ha
fusing body 102 and lid 104, respectively, as shown in FIGS. 15 and
17.
[0179] Then when the container carriage 206 moves forward in later
stages of operation it immediately moves the needle hub 140 forward
while the needle protection frame 154 remains feed in place
relative to the housing 102.
Interlock Requirements
[0180] The following Table II describes the required interlocks
through one complete injection cycle for apparatus 100. In Table II
the flexible container 108 is referred to as a sachet.
TABLE-US-00002 TABLE II Full Device Failure Interlock Skin Lid No
sachet in Device State Sachet Mode Required Contact Trigger closed
Sachet place Fires Device closed - None None None 1 0 1 0 0 No Drug
delivered Device open - None Device Fires, lid snaps shut. Device
cannot 1 1 0 0 0 No Primed High impact on end stops fire with lid
without sachet to dampen open forces. Device primed - None Device
mechanism damaged Device cannot 1 1 1 0 0 No Closed hitting end
stops hard if fire without a fired. Mechanism abuse sachet in
possible (biro type playing) position Device open - Full Device
Fires, lid snaps shut. Device cannot 1 1 0 1 1 No Primed Drug
delivered without body fire with lid contact open Device primed -
Full Device fires when not in Device will only 1 1 1 1 1 Yes Closed
contact with skin, dose lost fire with skin contact Device closed -
Used None None 1 0 1 1 0 No Drug delivered Device open - Used
Device mechanism damaged Device cannot 1 1 0 1 0 No Primed hitting
end stops hard if fire with lid fired. Used needle fires again open
Device primed - Used Used needle fires a second Sachet locked 1 1 1
1 0 No Closed time after use
[0181] The device trigger 270 must only become unlocked when skin
contact is made with the needle end of the device 100.
[0182] The `no sachet` interlock and `used sachet` interlock could
become one feature if there was a permanently displaceable
component on the container carriage 208 that interacted with the
`no sachet` interlock.
[0183] The `lid closed` interlock must be well recessed to prevent
activation by any means other than the lid 104 being closed in
place. This may include multiple contact points.
Fixed Roller Embodiments of FIGS. 27-30
FIG. 27
[0184] In the embodiments of FIGS. 1-24 described above, during the
relative movement between the roller and the flexible container
wherein the medicant is expelled from the flexible container, the
flexible container has been held in a fixed position relative to
the housing and the roller has moved longitudinally relative to the
housing to roll over the flexible container to expel the medicant.
It is also possible to achieve the same relative motion between the
roller and the flexible container by holding the roller in a fixed
position relative to the housing while moving the flexible
container in a longitudinal direction relative to the housing.
Several such arrangements are schematically illustrated in FIGS.
27-30.
[0185] FIGS. 27 schematically shows an injection apparatus 300
including a cartridge 302 carried in a container carriage 304. The
container carriage 304 functions in a manner similar to the
container carriage 208 described above and is powered by a main
drive spring (not shown) which may be a coil strip main drive
spring similar to drive spring 226 described above. The carriage
304 and the drive spring are received in a housing (not shown)
similar to housing 102 described above.
[0186] The cartridge 302 includes a needle hub 306 having a needle
308 extending proximally therefrom. A roller 310 having first and
second coaxial spaced roller portions 312 and 314 is longitudinally
fixed relative to the housing so that the roller 310 rotates
relative to the housing but does not move longitudinally relative
to the housing. The needle 308 extends between the roller portions
312 and 314. The roller portions 312 and 314 engage first and
second flexible containers 320 and 322 which are communicated at
their distal ends with needle hub 306 and thus with needle 308.
[0187] As the container carriage 304 begins moving in the direction
316 relative to the housing and relative to the longitudinally
fixed rollers 310, the needle 308 will pierce a flexible needle
protective sleeve 318 and will be inserted into a patient's body.
Further movement of the container carriage 304 moves the first and
second flexible container compartments 320 and 322 past the fixed
rollers 312 and 314 so that the rollers squeeze the medicant
contained in the flexible containers 320 and 322 out through the
needle hub 306 and through the needle 308 into the patient's
body.
[0188] With the embodiment of FIG. 27, as the container carriage
304 moves forward the needle 308 will continue to be inserted
deeper into the patient's body while the medicant is simultaneously
being expelled through the needle 308 into the patient's body. Thus
some portion of the needle insertion and the drug injection can
occur simultaneously.
[0189] In all applicable respects other than the geometry of the
arrangement, the details of construction of the flexible containers
320 and 322, the needle hub 306 and other components of the
apparatus 300 will be similar to those of the apparatus 100
described in detail above.
FIG. 28
[0190] FIG. 28 schematically illustrates an embodiment somewhat
similar to that of FIG. 27, except in the embodiment of FIG. 28, a
secondary carriage is provided to first partially insert the needle
into the patient's body.
[0191] Thus in FIG. 28 an apparatus 400 is shown including a
cartridge 402 carried in a container carriage 404 which is in turn
carried in a secondary carriage 424. The apparatus 400 includes
needle hub 408, needle 408, roller 410 with roller portions 412 and
414, sheath 418 and flexible containers 420 and 422 all similar to
the analogous components described above with regard to FIG. 27.
The roller portions 412 and 414 are longitudinally fixed to the
secondary carriage 424.
[0192] The secondary carriage 424 carries the container carriage
404 and accompanying components to initially insert the needle 408
into the patient's body. Then further motion of the container
carriage 404 relative to the secondary carriage 424 moves first and
second flexible container compartments 420 and 422 past first and
second roller portions 412 and 414 of roller 410 in the direction
416 to expel the medicant from the container portions 420 and 422
and into the patient.
[0193] The motion of container carriage 404 relative to secondary
carriage 424, and the motion of secondary carriage 424 relative to
the housing (not shown) may be driven by any suitable spring or
other power source, such as coil strip springs like 226 or helical
springs like 234.
FIG. 29
[0194] FIG. 29 schematically illustrates another embodiment of the
fixed roller apparatus which is generally designated by the numeral
500.
[0195] The apparatus 500, similar to the apparatus 300 of FIG. 27,
includes a U-shape or dual chamber flexible container 502 having
first and second container portions 504 and 506. A bottom portion
508 of the U-shape flexible container 502 may include a needle hub
similar to the needle hub 306 and similar to the needle huh 140
described above.
[0196] A needle 509 extends proximally from the needle hub 508.
Proximal ends 510 and 512 of the flexible container portions 504
and 506 are attached to a pull bar 514. Intermediate portions 516
and 518 of the first and second container portions 504 and 506 are
wrapped around first and second roller portions 520 and 522 of
roller 524. The roller 524 is fixedly attached to the apparatus
housing (not shown) so as to rotate relative to the housing without
moving longitudinally relative to the housing.
[0197] A main drive spring (not shown) attached to the pull bar 514
pulls the pull bar 514 in a distal direction as indicated by arrow
526. This causes the portions of the flexible containers 504 and
506 located above the roller 524 to be pulled distally while the
portions of the flexible containers 504 and 506 located below the
roller 524 move proximally in the direction indicated by arrow
528.
[0198] As those lower portions of the flexible container move
proximally, they pull forward the needle hub 508 and the attached
needle 509 moving them proximally so as to insert the needle 509 in
the patient and to expel medicant from the container portions 504
and 506 through the needle 509 into the patient. The container
portions 504 and 506 may initially be only partially filled so that
the initial forward motion of needle 509 to insert the needle into
the patient's body may occur before the drug begins to be expelled
through the needle.
[0199] With the embodiment of FIG. 29 the initial proximal movement
of the needle 509 serves to collapse a needle protection sheath 530
and insert the needle 509 into the patient, and continued proximal
movement of the needle 509 will further insert the needle 509 into
the patient while medicant is simultaneously expelled from the
flexible container portions 504 and 506 through the needle 509 into
the patient.
FIG. 30
[0200] FIG. 30 schematically illustrates a further embodiment
identified by the numeral 600 which is similar to the embodiment of
FIG. 29 except that it adds a secondary carriage 602. Other
components are numbered the same as in FIG. 29.
[0201] The secondary carriage 602 provides an initial proximal
movement in direction 528 of the entire flexible container 502 and
associated structures of FIG. 29, to an initial position which will
insert the needle 509 into the patient. Then a main drive spring
(not shown) initiates the motion of the pull bar 514 in the
direction 526 relative to the secondary carriage 602 and the main
housing to further inject the needle 509 and expel the medicant
from the flexible container 502.
[0202] In general, with regard to all of the embodiments described
above, the roller can be said to engage its associated flexible
container and expel the medicant from the container through the
needle upon relative movement between the roller and the container.
In each case the roller has a rotational axis and the relative
movement between the roller and the container is a relative
longitudinal movement in a longitudinal direction transverse to the
rotational axis.
[0203] In some embodiments such as those of FIGS. 10-25, the
flexible container is longitudinally fixed relative to the housing
during the injection process, and the roller moves longitudinally
relative to the container and the housing. In other embodiments
such as FIGS. 27-30, the roller is longitudinally fixed relative to
the housing during the injection process, and the container moves
longitudinally relative to the roller and the housing.
Single Use Embodiment of FIG. 25
[0204] FIG. 25 is a schematic perspective exploded view of a single
use embodiment of the auto-injector apparatus. FIG. 25 is similar
in many aspects to FIG. 10, and those components of FIG. 25
identical to the components of FIG. 10 are identified with the same
numerals as used in FIG. 10, and those components which have been
modified are indicated wife a prime suffix. Thus the apparatus of
FIG. 25 is referred to as the apparatus 100'. The housing includes
a main housing body 102' and a lid 104', however the lid is not
designed for repeated opening and closing. Instead, the lid 104' is
designed to be permanently attached to the main housing body 102'
so that the housing 102', 104' comprises a closed single use
housing having an interior 202 which is inaccessible by a user
without damage to the housing.
[0205] The single use apparatus 100' may utilize the same container
carriage 206, roller 210, roller cam 218, main drive spring 226,
return chassis 208, and retraction spring 234 as were described
above with regard to the multi-use apparatus 100.
[0206] The primary deletions from the apparatus 100 of FIG. 10
include the cocking linkage 244 and its gears 246 and 248, the main
drive rack 250, the drive gear 252, and the spring rack 254, all of
which have been eliminated because there is no need for opening of
the housing or reloading of the housing with a cartridge.
[0207] Although not shown in FIG. 25, the single use apparatus 100'
will use the same cartridge assembly 106 as described above, which
will be carried in the container carriage 206 in the same manner as
described above with regard to the apparatus 100. The difference is
that a single cartridge 102 will be placed within the apparatus
100' prior to sealing the lid 104' on the main housing body 102',
and there is no replacement of that cartridge after use. Thus when
the apparatus 100 is assembled, a cartridge 106 is placed within
the cartridge carrier 206. The roller 210, roller cam 218, main
drive spring 226, container carriage 206, return chassis 208 and
retraction spring 234 are all placed in positions analogous to
those shown in FIGS. 17, 18, 18A-A and 18B-B. The triggers 266 and
270 as shown in FIG. 18A-A are in place.
External Packaging For Single Use Embodiment:
[0208] FIGS. 41 and 42-43 show two different types of external
packaging that can be used with the single use injector device
100'.
[0209] In FIG. 41 the device 100' is contained in an opaque,
preferably metal foil, outer package 740 which is constructed like
the package 700 described above with regard to FIG. 35. Package 740
has notches 742 and 744 which allow the user to tear the package
open to access the single use device 100'. The device 100' has a
transparent window 746 formed in the front thereof so that the
flexible container 108 of the cartridge 106 contained therein may
be viewed to confirm that the container 108 is filled with medicant
prior to use of the device 100'.
[0210] FIGS. 42 and 43 show a single use device 760 similar to the
device 100' of FIG. 25, hut with a transparent widow 762 formed in
the front thereof. The window 762 is initially blocked in FIG. 42
by an opaque pull strip 764. Prior to use of the apparatus 760, the
strip 764 is pulled to a second position as shown in FIG. 43, thus
exposing the cartridge 106 to view through the transparent window
762. This allows the transparent flexible container 108 of the
cartridge 106 to be viewed through the window 762 to confirm that
the container 108 is full of medicant prior to use of the device
760, and to confirm that the medicant is clear and free of
particulates. A second transparent window and pull strip is
preferably provided on the other side of the device 760 to allow a
see through inspection of the container 108. The pull strips
preferably are constructed as integral portions of a secondary
package around the flexible container 108, so that portions of the
package are peeled back to expose the container 108 when the pull
strips are pulled. The secondary container including the pull
strips should block exposure of the container 108 to light passing
through the window 762 prior to pulling the pull strips.
Methods of Use
[0211] The methods of use of the apparatus will now be described
with regard to FIGS. 9-24 and the schematic views of FIGS.
2A-2G.
[0212] One example of a method of auto-injecting a liquid medicant
into a patient may include: [0213] (a) Placing a proximal end 272
of as auto-injector apparatus 100 or 100' against a patient's body
101--the patient's body 101 is only schematically illustrated and
may for example be an arm or thigh of the patient such as typically
used as an injection site; [0214] (b) Releasing a main drive spring
226 such as for example by manually releasing second trigger 270 by
depressing the same as indicated by arrow 103 in FIG. 2E; [0215]
(c) Driving the needle 144 proximally within the apparatus 100 or
100' with the main drive spring 226 so that the needle 144 extends
out of the proximal end 272 of the apparatus 100 or 100' thereby
inserting the needle 144 in the patient's body 101; and [0216] (d)
Creating relative motion between roller 210 and flexible container
108 by rolling the roller 210 over the flexible medicant container
108 within the apparatus 100 or 100' with the main drive spring 226
after or while the needle 144 is being inserted in the patient's
body 101 and thereby forcing the medicant out of the medicant
container 108 through the needle 144 into the patient's body 101.
During the relative motion between the roller and the flexible
container to force the medicant out of the container, a frangible
seal within the flexible medicant container is broken so that the
medicant can flow from the container to the needle.
[0217] After injecting the medicant into the patient's body, the
needle return chassis 208 is released to retract the needle 144
back into the apparatus 100 or 100' with the retraction spring 234
as shown for example in FIG. 2G and in FIGS. 23, 24, 24A-A and
24B-B.
[0218] Those steps just described are applicable to both the
multi-use apparatus 100 of FIGS. 10-24 and the single use apparatus
100' of FIG. 25.
[0219] For the multi-use apparatus 100 of FIGS. 10-24, the
apparatus can further be reloaded by opening the lid 104 of the
apparatus 100 to provide access to the interior 202. That opening
action extends the main drive spring 236 and the retraction spring
234 so that the springs 236 and 234 are in position to repeat the
insertion of the needle and injection of the medicant into the
patient. After opening the lid, the spent medicant container 106
including its needle 144 is removed from the apparatus 100 and a
new medicant container and needle assembly 106 are placed in the
apparatus 100.
[0220] The overall method of operation of the multi-use apparatus
100 of FIGS. 10-24 is schematically illustrated in the seven
sequential positions set forth in FIGS. 2A-2G. It is noted that the
seven steps represented by FIGS. 2A-2G correspond to the seven
positions of the apparatus 100 illustrated in FIGS. 11, 13, 15, 17,
19, 21 and 23, respectively.
[0221] Thus, in FIG. 2A, FIG. 11, FIG. 12, FIG. 12A-A and FIG.
12B-B, the apparatus 100 begins in an unprimed state after the
previous injection.
[0222] In FIG. 2B, FIG. 13, FIG. 14, FIG. 14A-A and FIG. 14B-B the
lid 104 of the apparatus 100 has been opened. This has reset the
main drive spring 226 and the retraction spring 234, and has moved
roller 210, container carriage 206 and needle return chassis 208 to
the positions illustrated in FIGS. 14A-A and 14B-B.
[0223] In FIG. 2C, FIG. 15, FIG. 16, FIG. 16A-A and FIG. 16B-B a
new cartridge assembly 106 has been inserted into the apparatus
100.
[0224] In FIG. 2D, FIG. 17, FIG. 18, FIG. 18A-A and FIG. 18B-B the
lid 104 has been closed and the apparatus 100 is primed and ready
for use.
[0225] In FIG. 2E, FIG. 19, FIG. 20, FIG. 20A-A and FIG. 20B-B the
distal end 272 of the apparatus 100 is held against the patient's
body 101 and the trigger 270 is fired manually by the user
depressing the same with a thumb as indicated by arrow 103. The
trigger 270 shifts the spring rack 254 sideways thus demeshing it
from the drive gear 252 which releases the container carriage 206
which is then driven forward by the main drive spring 226 thus
driving the needle 144 into the patient's body 101.
[0226] It is noted that in FIG. 2E the needle 144 is not shown,
whereas the needle 144 is shown protruding from the housing 102 in
FIGS. 19 and 20. It will be understood that as a result of
actuating the trigger 270 as indicated in FIG. 2E the needle 144
will move forward and will protrude from the apparatus 100 into the
patient's body 101 as shown for example in FIG. 2F.
[0227] FIG. 2F, FIG. 21, FIG. 22, FIG. 22A-A and FIG. 22B-B
illustrate the position of the various components of the apparatus
100 after the main drive spring 226 has driven the roller 210
forward to expel the liquid medicant from the flexible container.
When the roller reaches the end of its travel it trips trigger
266.
[0228] FIG. 2G, FIG. 23, FIG. 24, FIG. 24A-A and FIG. 24B-B
illustrate the position of the components after trigger 266 has
released the needle return chassis 208 so that the retraction
spring 234 draws the needle return chassis 208, the container
carriage 206 and the cartridge assembly 106 back within the housing
thus withdrawing the needle 144 from the patient.
[0229] In the arrangement just described with reference to FIGS.
2A-2G the proximal end 272 was first pressed against the patient's
body to arm the device, and then trigger 270 was pressed to fire
the device. Alternatively the various interlocks between the
operating components can be arranged so that the trigger 270 must
first be pressed to arm the device, and then when distal end 272 is
pressed against the patient's body the device will automatically
fire.
The Alternative Pump Embodiments of FIGS. 31-34
FIGS. 31A-31B
[0230] As previously noted, the roller 210 may be generally
described as a pump 210 disposed in the housing and positioned to
engage the flexible container 108 and expel the medicant from the
container 108 through the needle 144. FIGS. 31-34 schematically
illustrate alternative pump arrangements which could be substituted
for the roller pump 210.
[0231] FIGS. 31A and 31B a pump 610 includes an inflatable balloon
or bladder 612 powered by compressed gas or expanding chemical
reaction producing reaction gases from gas source 611 via conduit
616.
[0232] In FIG. 31A the balloon pump 610, 612 is schematically shown
in an uninflated position. In FIG. 31B the pump 610, 612 is
schematically shown in an inflated position. As the balloon 612
inflates within the housing, it acts against the flexible container
108 thus compressing the flexible container 108 to a compressed
condition as shown in FIG. 31B which expels the medicant from the
container 108 through the frangible seal 143 to the needle hub 140.
The expanding balloon 612 applies pressure to the flexible
container 108 thus squeezing the flexible container 108 from its
original condition shown in FIG. 31A to its compressed position
shown in FIG. 31B.
FIGS. 32A-32B
[0233] Referring now to FIGS. 32A-32B, a magnetic pump 620 includes
a pair of magnets 622 and 624. The magnets at one end are pivotally
connected at 626. At the other end a mechanical blocking device
schematically indicated at 628 holds the magnets apart so as to
define a gap 630 therebetween within which the flexible container
108 is located. Upon removing the mechanical blocker 628, the
magnet 622 moves toward the magnet 624 thus closing the gap 630 and
applying pressure to the flexible container 108 to collapse the
flexible container 108 to a position such as schematically
illustrated in FIG. 32B, thus expelling the medicant from the
flexible container 108. The magnetic pump 620 can be described as
comprising a pair of magnets 622 and 624 on opposite sides of the
flexible container 108.
FIGS. 33A-33B
[0234] FIGS. 33A-33B schematically illustrate an electromagnetic
pump 640 which includes an electromagnet 842 and a magnetically
attractive mass 644 on opposite sides of the flexible container
108. The electromagnet 642 may be an electric coil type magnet
which receives electrical power from battery 646 via wires 648. The
magnetically attractive mass 644 may be a steel plate. In the
unactuated position of FIG. 33A a gap 650 is defined between
electromagnet 642 and steel plate 644, and the flexible container
108 is located in the gap 650.
[0235] When current from battery 646 is applied to the coil of
electromagnet 642 the steel plate 644 is drawn toward electromagnet
642 thus closing the gap 650 and compressing the flexible container
108 to a condition like that schematically illustrated in FIG. 33B,
thus squeezing the medicant out of the flexible container 108
through the frangible seal 143 to the needle hub 140. The steel
plate 644 may ride on guideposts 652 and 654 extending upwardly
from the electromagnet 642.
FIGS. 34A-34B
[0236] FIGS. 34A and 34B schematically illustrate an alternative
pump apparatus 660 wherein the pump comprises construction of the
flexible container 108 from a resilient material so the container
can be pressurized to an expanded position as shown in FIG. 34A.
When it is desired to expel the medicant from the flexible
container 108, the frangible seal 143 is breached by any suitable
means, thus allowing the stretched walls of container 108 to
retract to the position of FIG. 34B, thus forcing the medicant out
of container 108 and past breached seal 143 to needle hub 140.
[0237] Thus it is seen that the apparatus and methods of the
present invention readily achieve the ends and advantages mentioned
as well as those inherent therein. While certain preferred
embodiments of the invention have been illustrated and described
for purposes of the present disclosure, numerous changes in the
arrangement and construction of parts and steps may be made by
those skilled in the art, which changes are encompassed within the
scope and spirit of the present invention as defined by the
appended claims.
* * * * *