U.S. patent application number 12/864685 was filed with the patent office on 2011-05-19 for dose dividing delivery device.
Invention is credited to Bruno Baney, Patrick Dupuis, Colin May, Frederic Perot.
Application Number | 20110118701 12/864685 |
Document ID | / |
Family ID | 39767018 |
Filed Date | 2011-05-19 |
United States Patent
Application |
20110118701 |
Kind Code |
A1 |
Baney; Bruno ; et
al. |
May 19, 2011 |
Dose Dividing Delivery Device
Abstract
A simple method and device enabling a unit dose from a reservoir
is provided. The dose is drawn into the reservoir and is then
expelled from the device by depressing the plunger. The plunger
(30) has features which divide the dose into discrete intervals. As
the plunger is moved during delivery, features on the plunger and
features connected to the barrel interact to provide for
intermittent stops to the injection process. Other aspects of the
device provide-for reduced dead space, safety and selective
interconnection with other devices. Thus, the delivery device
divides the dose.
Inventors: |
Baney; Bruno; (Claix,
FR) ; May; Colin; (London, GB) ; Dupuis;
Patrick; (Jarrie, FR) ; Perot; Frederic;
(Saint Paul de Varces, FR) |
Family ID: |
39767018 |
Appl. No.: |
12/864685 |
Filed: |
January 30, 2008 |
PCT Filed: |
January 30, 2008 |
PCT NO: |
PCT/IB2008/001028 |
371 Date: |
February 1, 2011 |
Current U.S.
Class: |
604/506 ;
604/192; 604/208 |
Current CPC
Class: |
A61M 5/31528 20130101;
A61M 5/3243 20130101; A61M 5/31526 20130101; A61M 5/3134 20130101;
A61M 5/3293 20130101; A61M 5/31595 20130101 |
Class at
Publication: |
604/506 ;
604/208; 604/192 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Claims
1) A multiple dose injection device comprising: a fluid conduit; a
barrel having a bore, a distal end, and a proximal end wherein the
fluid conduit is located at the distal end of the barrel, in fluid
communication with the bore and the proximal end of the barrel is
adapted to receive a stopper; a plunger having a distal end and a
proximal end and a longitudinal axis wherein the stopper is
connected the distal end of the plunger and movable within the
barrel, and the plunger has at least one continuous track formed
between the distal and proximal ends of the plunger wherein the
track further comprises at least one of each of the following: a
first rest position, a stop position, having a proximal abutment, a
second rest position, a camming portion which is skewed to the
longitudinal axis of the plunger and formed between the first rest
position and the stop; a reset portion substantially perpendicular
to the axis of the plunger and formed between the stop an the
second rest position; and, a slider having a follower movable
substantially perpendicular to the axis of the plunger, the slider
having a user-pressable portion; wherein when a portion of the
plunger is depressed by a user, the follower moves with respect to
the plunger along the camming portion of the track, thereby causing
radial motion of the follower and movement of the follower to the
stop position at which position the plunger distal movement is
prevented by contact of the follower to the proximal abutment,
wherein the user may apply biasing force to the user-pressable
portion of the slider, thereby moving the follower along the reset
portion to the second rest position.
2) A device as set forth in claim 1) wherein the follower is
movable from an initial position wherein the follower is located
outside of the track and does not interfere with the plunger
movement, to a first position wherein the follower is located
within the track.
3) A device as set forth in claim 1) further comprising a loading
portion of the track located at a distal portion of the plunger
wherein the loading portion allows the follower to enter the track
and the follower to the first rest position.
4) A device as set forth in claim 1) wherein the axial distance
between stop positions multiplied by the cross sectional area of
the bore is a unit volume which comprises a unit dose.
5) A device as set forth in claim 5) wherein the unit dose is a
plurality of unit doses and all unit doses are substantially
equal.
6) A device as set forth in claim 5) wherein the unit dose is a
plurality of unit doses and all unit doses are of varying
dosages.
7) A device as set forth in claim 1) further comprising a clip
which engages a flange on the barrel and the slider is slidably
engaged to the clip.
8) A device as set forth in claim 7) the clip further comprising a
plunger guiding portion.
9) A device as set forth in claim 7) wherein the clip and slider
are integrally formed with a slidable relationship.
10) A device as set forth in claim 1) wherein the at least one
continuous track further comprises two tracks, located on opposing
sides of the plunger.
11) A device as set forth in claim 1) wherein the at least one
continuous track is a helical track around the circumference of the
plunger.
12) A device as set forth in claim 1) wherein the follower is
mounted on a deflectable beam.
13) A device as set forth in claim 1) wherein the follower is
elastically deformed in use.
14) A device as set forth in claim 12) wherein the reset portion
further comprises a detent tab located in the track which deflects
the follower.
15) A device as set forth in claim 12) wherein the reset portion
further comprises a deflectable detent tab located in the
track.
16) A device as set forth in claim 14) wherein the deflection
creates an audible sound, thereby providing feedback to the
user.
17) A device as set forth in claim 1) wherein the fluid conduit
further comprises a detachable needle assembly having a hub,
attachable to the distal end of the barrel and a needle inserted
into the hub.
18) A device as set forth in claim 17) wherein the hub further
comprises a proximal opening adapted to receive an elongated luer
tip located at the proximal end of the barrel and is adapted to
prevent effective use of a standard luer tipped barrel.
19) A device as set forth in claim 1) further comprising a
restrictor pin within the fluid conduit thereby reducing dead
space.
20) A device as set forth in claim 1) further comprising a hub
engaged to the barrel having needle cover removably attached to
said hub.
21) A device as set forth in claim 20) further comprising a shield
which is slidably engaged to the hub.
22) A multiple dose injection device comprising: a fluid conduit; a
barrel having a bore, a distal end, and a proximal end wherein the
fluid conduit is located at the distal end of the barrel, in fluid
communication with the bore and the proximal end of the barrel is
adapted to receive a stopper; a plunger having a distal end and a
proximal end and a longitudinal axis wherein the stopper is
connected the distal end of the plunger and movable within the
barrel, and the plunger has at least one continuous track formed
between the distal and proximal ends of the plunger wherein the
track further comprises at least one of each of the following: a
first rest position, a stop position, having a proximal abutment, a
second rest position, a capturing portion formed between the first
rest position and the stop; a reset portion substantially
perpendicular to the axis of the plunger and formed between the
stop an the second rest position; and, a slider having a follower
movable substantially perpendicular to the axis of the plunger, the
slider having a user-pressable portion; wherein the follower is
biased toward the stop, thereby radially biasing the follower in
the capture portion to the stop position at which position the
plunger distal movement is prevented by contact of the follower to
the proximal abutment, wherein the user may apply a reverse biasing
force to the user-pressable portion of the slider, thereby moving
the follower along the reset portion to the second rest
position.
23) A device as set forth in claim 22) wherein the follower is
movable from an initial position wherein the follower is located
outside of the track and does not interfere with the plunger
movement, to a first position wherein the follower is located
within the track.
24) A device as set forth in claim 22) further comprising a loading
portion of the track located at a distal portion of the plunger
wherein the loading portion allows the follower to enter the track
and the follower to the first rest position.
25) A device as set forth in claim 22) wherein the axial distance
between stop positions multiplied by the cross sectional area of
the bore is a unit volume which comprises a unit dose.
26) A device as set forth in claim 25) wherein the unit dose is a
plurality of unit doses and all unit doses are substantially
equal.
27) A device as set forth in claim 25) wherein the unit dose is a
plurality of unit doses and all unit doses are of varying
dosages.
28) A device as set forth in claim 22) further comprising a clip
which engages a flange on the barrel and wherein the clip and the
slider are integrally formed with a slidable relationship
therebetween.
29) A device as set forth in claim 22) wherein the at least one
continuous track further comprises two tracks, located on opposing
sides of the plunger.
30) A device as set forth in claim 28) further comprising
integrated leaf springs which are integrally molded.
31) A device as set forth in claim 22) wherein the follower is
mounted on a deflectable beam.
32) A device as set forth in claim 31) wherein the deflection
creates an audible sound, thereby providing feedback to the
user.
33) A device as set forth in claim 22) wherein the fluid conduit
further comprises a detachable needle assembly having a hub,
attachable to the distal end of the barrel and a needle inserted
into the hub.
34) A method of performing a multiple dose delivery comprising:
providing a device comprising a fluid conduit; a barrel having a
bore, a distal end, and a proximal end wherein the fluid conduit is
located at the distal end of the barrel, in fluid communication
with the bore and the proximal end of the barrel is adapted to
receive a stopper; a plunger connected to the stopper and movable
within the barrel, thereby forming a reservoir, the plunger having
a longitudinal axis and at least one continuous track formed
between a distal end of the plunger and a proximal end of the
plunger wherein the track further comprises at least one of each of
the following: a first rest position, a stop position, having a
proximal abutment, a second rest position, a camming portion not
parallel to the longitudinal axis of the plunger and formed between
the first rest position and the stop position; a reset portion
substantially perpendicular to the axis of the plunger and formed
between the stop an the second rest position; and, a slider having
a follower and a user depressable portion; filling the reservoir of
the device with a fluid; moving the slider from an initial position
wherein the follower is located outside of the track and does not
interfere with plunger movement, to a first position wherein the
follower is located within the track; depressing a portion of the
plunger to dispense a portion of the fluid through the fluid
conduit and thereby moving the follower with respect to the plunger
along the camming portion of the track, thereby causing radial
motion of the follower and movement of the follower to the stop
position wherein the plunger distal movement is prevented by
contact of the follower to the proximal abutment; applying a
biasing force to the user-pressable portion of the slider, thereby
moving the follower along the reset portion to the second rest
position which coincides with the first rest position; and,
repeating the depressing and applying steps until all the fluid is
dispensed from the reservoir.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to delivery devices
for delivering substances such as drugs, vaccines and the like, and
more specifically relates to a drug delivery system and device
having a system for dividing the dose into multiple sub-doses for
injection through a needle. More specifically, the present
invention relates to a method and apparatus for filling, dosing and
disposing an intradermal delivery device using a needle sized for
intradermal delivery and a dose divider for dividing the dose for
multiple injections using the same needle.
BACKGROUND OF THE INVENTION
[0002] Traditionally, syringes are filled by inserting the needle
into a vial. The dose is drawn from the vial, pulling the liquid
drug dose from the vial into the syringe. The dosage is then
expelled from the device by depressing the plunger. If it is
desired to divide the total dose into discrete intervals, it must
be accomplished manually, or via complicated and costly systems. In
the actual usage of devices of this type, multiple doses are given
to the same patient at various locations. With a conventional
syringe the practitioner must stop depressing the plunger based on
visual feedback (from the scale on the syringe). Consequently, it
is difficult to perform the repeat dose injections with a high
degree of accuracy and/or precision. Furthermore, intradermal
injections which can be performed at repeated sites are difficult
to perform and adding the difficulty of manually dividing the dose
at each site has historically been difficult. Medication pens were
developed to produce multiple injections, but are complicated and
comprised of many parts. For example, a pen like device is
described in U.S. Pat. No. 4,592,745. This pen device is
complicated and performs multiple injections but with significant
cost. Furthermore, medication pens are not readily adapted for use
with fill at time of use systems, especially systems which require
reconstitution steps. What is needed is a device and technique for
expelling repeated doses from a fill able single syringe to perform
multiple injections without having to solely rely on visual
feedback from the scale of the syringe, or complicated devices with
multiple parts. Furthermore, what is needed is a system that
divides the dose that is compatible with conventional
reconstitution practices. Attached are the results of a general
background search which was conducted for the dose dividers.
SUMMARY OF THE INVENTION
[0003] In one embodiment the medication device having aspects of
the invention uses a radially moving collar having a cantilevered
beam which serves as a pawl. The collar is slidable from a first
position to a second position on the flange of the syringe barrel.
Furthermore, the plunger of the device is ratcheted with a
plurality of spaced detents. In the first position the collar is
positioned such that the pawls of the cantilevered beams do not
interact with the ratchets of the plunger. A filling needle is
attached to the syringe barrel. The first position is the filling
position and allows the syringe to be used as a conventional
syringe; however, in the usage of this device, the first position
primarily serves to fill the syringe using a filling needle without
interference by the ratchets. The filling needle is removed from
the barrel and an injection needle is attached. The collar is moved
to a second position. In the second position the collar is
positioned such that the pawls of the cantilevered beams interfere
with the detents of the plunger. This position allows the syringe
to be used as a multiple repeat dose device. The practitioner
inserts the needle into the patient and depresses the plunger. As
the plunger is depressed, the pawls interact with the detents which
provide for tactile feedback to the practitioner that the discrete
intermediate dosage has been delivered. The practitioner then moves
the needle to a new injection site and repeats the process. This
process continues until the entire dose is delivered.
[0004] In another embodiment having aspects of the invention, the
device uses a radially slidable component having a follower. The
component is slidable from a first position to a second position on
the flange of the syringe barrel or on an intermediate part snapped
on the syringe flange. Furthermore, the sides of the plunger are
grooved with a track having a plurality of spaced units having at
least a stop portion. In some embodiments the track has an angled
portion, and in others there is a capture portion. In alternate
embodiments the track is along the contoured radial surface of the
plunger, as the track. In yet another embodiment, the track is
configured with units such that the follower is caught in retention
areas. In alternate embodiments the plunger contains a plurality of
followers and the track is on the slider, thus reversing the
location of the features on the parts. In the first position the
component is positioned such that the follower of the component
does not interact with the tracks of the plunger. Optionally, a
filling needle is attached to the syringe barrel. The first
position is the filling position and allows the syringe to be used
as a conventional syringe; however, in usage of this device the
first position primarily serves to fill the syringe using a filling
needle (or injection needle) without interference by the
follower/tracks. The filling needle is removed from the barrel and
an ID injection needle is attached. The component is moved to a
second position. In the second position the component is positioned
such that the follower of the component is riding in the track of
the plunger, and is at the start of an injection cycle. In this
case it is at the bottom of a unit. This is the discrete injection
position and allows the syringe to be used as a multiple repeat
dose device. The practitioner inserts the needle into the patient
and depresses the plunger. As the plunger is depressed and begins
to move distally, the follower travels along the track. As the
follower travels along the angled portion of the track, the
component is moved to a third position which is intermediate to the
first and second position. At the cusp of the unit, the follower
hits a stop point, which is the beginning of the adjacent unit,
wherein the plunger is prevented from moving distally. The
practitioner then moves the component from the third position to
the second position which places the follower at the beginning of
angled portion of the adjacent unit. The practitioner then moves
the needle to a new injection site and repeats the process. This
process continues until the entire dose is delivered.
BRIEF DESCRIPTION OF THE DRAWINGS
[0005] Other advantages of the present invention will be readily
appreciated as the same becomes better understood by reference to
the following detailed description when considered in connection
with the accompanying drawings wherein:
[0006] FIG. 1 shows a perspective view of a delivery device having
aspects of the invention.
[0007] FIG. 2 shows and Enlargement of Detail "A" of the delivery
device of FIG. 1.
[0008] FIG. 3 shows a side view of the distal end of the device of
FIG. 1 with the shield of the device removed.
[0009] FIG. 4 shows a perspective view of a slider of the
embodiment of FIG. 1.
[0010] FIG. 5 shows side view of a plunger of the embodiment of
FIG. 1.
[0011] FIG. 6 shows a perspective view of a slider/clip assembly of
the device of FIG. 1.
[0012] FIG. 7 shows a perspective view of a slider, clip and
plunger assembly of the device of FIG. 1.
[0013] FIG. 7A shows a perspective view of a clip and plunger
assembly of an alternate embodiment having aspects of the
invention.
[0014] FIG. 8 shows an enlarged side view of the plunger of FIG.
5.
[0015] FIGS. 9A and 9B show an enlarged side view of Detail "B" and
Detail "C" the plunger of FIG. 5, respectively.
[0016] FIG. 10 shows a cross-sectional view of the hub and barrel
assembly of FIG. 3 with the sheath and shield removed for
clarity.
[0017] FIG. 11A shows a perspective view of an alternate embodiment
of a clip, plunger and barrel having aspects of the invention.
[0018] FIG. 11B is a reverse perspective view of the components of
FIG. 11A.
[0019] FIG. 12 shows an enlarged side view of a plunger used in the
embodiment of FIG. 11A-B.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT
[0020] As used herein, the term "proximal" and derivatives thereof,
shall mean the end of an item or direction closest to the caregiver
during use of the subject invention. The term "distal" and
derivatives thereof, shall mean the end of an item or direction
towards a patient during use of the subject invention. As used
herein, the term "drug substance" and derivatives thereof shall
mean any substance that is intended for injection into a patient,
including, by way of non-limiting example, drugs, vaccines,
therapeutics, and the like. It will be obvious to a person of skill
in the art, and from the disclosure provided herein, that the
subject invention is not limited or otherwise defined by the type
or class of substance administered using the inventive injection
device.
[0021] For many drug substances, it may be desirable to fill the
delivery device at the point of, and immediately prior to use. In
this situation, the delivery device is normally filled from a unit
dose or multi-dose vial. A multi-dose vial may be more economical
and it enables the user to fill the delivery device with the
specific dose required. Alternatively, the syringe is pre-filled
with a diluent. Alternatively, the syringe is pre-filled with the
drug substance, and no filling step is required, and in this case
the follower may be pre-set to be within the track. The multi-dose
vial may be pre-filled with a liquid substance or with a dry
substance. For example, it is now conventional to reduce certain
drugs to a dry or powdered form to increase the shelf life of drugs
and reduce inventory space. Multi-dose vials are typically sealed
with an elastomeric stopper or septum. A needle on the delivery
device may be used to pierce the stopper or septum and draw the
drug substance from the vial into the delivery device, typically a
syringe. The drug substance may then be administered using the
delivery device, which is discarded after use, and the unit-dose
vial may be stored for further use. Alternatively, the drug
substance may be contained in a cryogenic vial. Furthermore, the
cryogenic vial may be involved in a complex multi-step
reconstitution procedure.
[0022] Standard methods for preserving the therapeutic and/or
diagnostic substances, such as maintaining them in liquid or powder
form in conventional vials for future use, may be used with the
intradermal devices of the present invention. The substances for
use with the device and method include vaccines and certain
medicaments and drugs. Additionally, these substances can be used
for diagnostic testing such as, for example, the Mantoux test to
determine immunity status against tuberculosis and immediate
hypersensivity status of Type I allergic diseases. Also, the
substance preferably intradermally delivered in accordance with
aspects of the methods and devices of the present invention is
selected from the group consisting of drugs, vaccines and the like
used in the prevention, diagnosis, alleviation, treatment, or cure
of disease, with the drugs including Alpha-1 anti-trypsin,
Anti-Angiogenesis agents, Antisense, butorphanol, Calcitonin and
analogs, Ceredase, COX-II inhibitors, dermatological agents,
dihydroergotamine, Dopamine agonists and antagonists, Enkephalins
and other opioid peptides, Epidermal growth factors, Erythropoietin
and analogs, Follicle stimulating hormone, G-CSF, Glucagon, GM-CSF,
granisetron, Growth hormone and analogs (including growth hormone
releasing hormone), Growth hormone antagonists, Hirudin and Hirudin
analogs such as hirulog, IgE suppressors, Insulin, insulinotropin
and analogs, Insulin-like growth factors, Interferons,
Interleukins, Leutenizing hormone, Leutenizing hormone releasing
hormone and analogs, Low molecular weight heparin, M-CSF,
metoclopramide, Midazolam, Monoclonal antibodies, Narcotic
analgesics, nicotine, Non-steroid anti-inflammatory agents,
Oligosaccharides, ondansetron, Parathyroid hormone and analogs,
Parathyroid hormone antagonists, Prostaglandin antagonists,
Prostaglandins, Recombinant soluble receptors, scopolamine,
Serotonin agonists and antagonists, Sildenafil, Terbutaline,
Thrombolytics, Tissue plasminogen activators, TNF-, and TNF-
antagonist, the vaccines, with or without carriers/adjuvants,
including prophylactics and therapeutic antigens (including but not
limited to subunit protein, peptide and polysaccharide,
polysaccharide conjugates, toxoids, genetic based vaccines, live
attenuated, reassortant, inactivated, whole cells, viral and
bacterial vectors) in connection with, addiction, arthritis,
cholera, cocaine addiction, diphtheria, tetanus, HIB, Lyme disease,
meningococcus, measles, mumps, rubella, varicella, yellow fever,
Respiratory syncytial virus, tick borne japanese encephalitis,
pneumococcus, streptococcus, typhoid, influenza, hepatitis,
including hepatitis A, B, C and E, otitis media, rabies, polio,
HIV, parainfluenza, rotavirus, Epstein Barr Virus, CMV, chlamydia,
non-typeable haemophilus, moraxella catarrhalis, human papilloma
virus, tuberculosis including BCG, gonorrhoea, asthma,
atheroschlerosis malaria, E-coli, Alzheimers, H. Pylori,
salmonella, diabetes, cancer, herpes simplex, human papilloma and
the like other substances including all of the major therapeutics
such as agents for the common cold, Anti-addiction, anti-allergy,
anti-emetics, anti-obesity, antiosteoporeteic, anti-infectives,
analgesics, anesthetics, anorexics, antiarthritics, antiasthmatic
agents, anticonvulsants, anti-depressants, antidiabetic agents,
antihistamines, anti-inflammatory agents, antimigraine
preparations, antimotion sickness preparations, antinauseants,
antineoplastics, antiparkinsonism drugs, antipruritics,
antipsychotics, antipyretics, anticholinergics, benzodiazepine
antagonists, vasodilators, including general, coronary, peripheral
and cerebral, bone stimulating agents, central nervous system
stimulants, hormones, hypnotics, immunosuppressives, muscle
relaxants, parasympatholytics, parasympathomimetrics,
prostaglandins, proteins, peptides, polypeptides and other
macromolecules, psychostimulants, sedatives, sexual hypofunction
and tranquilizers and major diagnostics such as tuberculin and
other hypersensitivity agents.
[0023] FIG. 1 shows a delivery device having aspects of the
invention. Delivery device 10 includes a syringe 11 with a barrel
40 and plunger 30. Plunger 30 is inserted into barrel 40 at the
proximal end of device 10. At the distal end of plunger 30 is a
stopper which is used to seal barrel 40 to form a reservoir for the
drug substance. At the proximal end of plunger 30 is push pad 32.
At the distal end of barrel 40 is attached needle assembly 12.
Needle assembly 12 is preferably comprised of hub 50 having a
needle, sheath 80 and shield 70. Shield 70 is removably attached to
the distal end of needle assembly 12. Preferably, needle assembly
12 is attached to barrel 40 via a threaded luer connection, however
other connection methods may be used, inter alia luer slip or
integral formation. Optional sheath 80 is slidably connected to hub
50 in order to protect the needle after use of the device.
Alternatively, a conventional needle assembly may be used such as
the type depicted in U.S. Pat. No. 6,494,865 to Alchas, the entire
contents of which is incorporated by reference herein, or a
standard hypodermic detachable needle. Alternatively, the needle
may be integrally assembled onto or into the barrel 40, such that
it is a not removable barrel. Typically barrel 40 is plastic but it
may be comprised of glass or any other material suitable for drug
delivery. At the proximal end of delivery device 10 is dose divider
13. Preferably, dose divider 13 includes a slider 20 and clip 60
which cooperate with plunger 30 to divide the entire dose contained
within the syringe 11 into preselected increments. The construction
and operation of the dose divider 13 is more readily seen in FIG. 2
and is described below.
[0024] Now turning to FIG. 2, the dose divider 13 includes a slider
20 having a button 21 which is depressible by the health care
professional. Slider 20 includes follower 28 which cooperates with
track 100 of plunger 30 to divide the entire dose of the drug
substance contained in the reservoir of the syringe into discrete
unit doses. The unassembled slider is shown in FIG. 4. Slider 20
includes follower 28 which is preferably mounted on deflectable
beam 27. In this embodiment opening 26 serves to allow beam 27, and
thus follower 28 to deflect in the radial direction. Thus since
opening 26 is a closed hole, beam 27 is a double supported beam.
Alternatively, opening 26 could be formed such that beam 27 is a
cantilevered beam. Alternatively, opening 26 could be omitted such
that follower 28 is located on a rigid portion of slider 20, and
follower 28 and/or track 100 is elastically deformed and movement
on a beam is not required. In this case, the parts would be sized
dimensionally such that the interference of the parts was not so
great to cause permanent deformation of the parts. Preferably,
slider 20 also includes at least one rail 22 which cooperates with
features on clip 60 to allow secure slidable engagement between the
parts. Follower 28 is a cylindrical protrusion with a portion which
is chamfered. Other profiles of protrusions may be used for
follower 28. Slider 20 is slidably engaged to clip 60 which is
attached to barrel 40. The engagement of slider 20 and clip 60 is
shown clearly in FIG. 6. Rails 22 cooperate with opening 62 on the
proximal side of clip 60 to provide a secure sliding connection
between clip 60 and slider 20. Other slidable connection means may
be employed inter alia detents, holes and pins, and slots and
followers. Clip 60 optionally includes radial opening 68 which
receives a flanged portion of barrel 40. Slider 20 with clip 60
attached to barrel 40 and slider 20 slidably engaged to clip 60,
slider 20 is able to be slid in a radial direction with respect to
the longitudinal axis of barrel 40, which would extend through
barrel opening 69 on distal side of clip 60. Furthermore,
substantial proximal and or distal movement of follower 28 with
respect to barrel 40 is substantially prevented by the design of
slider 20, clip 60 and connection methods employed. Preferably,
crush ribs 67 of clip 60 are used to provide a secure connection
between flange of barrel 40 and clip 60, which substantially
prevents relative movement in the barrel axial direction.
Optionally, all of the aspects of Clip 60 described herein would be
readily integrally formed into barrel 40, however, for ease of
using glass barrels, clip 60 is a separate component, however since
the connection of clip 60 to barrel 40 is a connection which
prevents any substantial distal or proximal movement of clip 60 to
barrel 40, they (clip 60, barrel 40) function as one. Clip 60
optionally includes tactile ribs 61 for gripping by the health care
professional. Clip 60 is attached to the distal end of barrel 40,
which preferably includes a flange. In this embodiment, Clip 60 is
slid radially onto a flange of barrel 40 before insertion of
plunger 30 into barrel 40. Clip 60 also preferably includes tang 66
which serves to guide plunger 30 in use of dose divider 30. Now
referring back to FIG. 2, for clarity, slider 20 is only shown with
follower 28 outside of track 100 of plunger 30. Furthermore, this
setting of slider 20 enables use of the syringe 11 as if there were
no dose divider 13 attached. In this setting, follower 28 does not
interact with track 100 to substantially hinder distal or proximal
movement of plunger 30. The dose dividing operation and cooperation
of follower 28 and track 100 are further shown in FIGS. 5, 8, and
9A-9B.
[0025] Shown in FIG. 5 is the plunger 30. Plunger 30 comprises
distal end with stopper retention means 33, and proximal end with
push button 32. Along an exterior surface of plunger 30 is track
100. Track 100 is comprised of one or more discrete units 101 which
each of which correspond to a unit dose. The distance between units
on Plunger 30 is directly correlated to the amount of substance
delivered for each unit. In one embodiment units are of equal size,
thus providing equal volumetric unit doses. In an alternate
embodiment, the units are differing sizes, thus providing varying
volumetric unit doses. Optionally, track 100 includes on distal
portion of plunger 30 a starting portion 107. Optionally, track 100
includes on proximal portion of plunger 30 an ending portion 108.
These portions are described more fully below and in FIG. 9A-B. In
FIG. 9B one can see a detail of starting portion 107 of track 100.
The two positions of the follower 28 are represented in FIG. 9B by
the position circles labeled A and B, labeled reference numerals
128 and 129, respectively. Position A 128 represents a position of
the follower that is outside of track 100. In this position there
is no interference of the movement of the plunger 30 by the
follower 28. To activate the dose dividing system the follower 28
is biased in the direct of the arrow labeled 118, from position A
128 to position B 129. In position B 129 the follower is within the
track, and subject to the guidance of track 100. More specifically
the follower 28 is within the starting portion 107 of the track
100; however, it is not mandatory that the follower 28 start in the
starting portion 107 of the track 100, only that in order to use
the device the follower 28 is within the track 100. In FIG. 9A one
can see a detail of finishing portion 108 of track 100 with angled
wall 112. Furthermore, the details of the unit 101 are described
below and in FIG. 8.
[0026] Now turning to FIG. 8, the sides of plunger 30 comprise
track 100 with a plurality of spaced units 101. Preferably units
101 are "Z" shaped. Track 100 has angled portions 102 with angled
wall portions 112, which are skewed from the longitudinal axis of
plunger 30. Track 100 also comprises a plurality of abutting walls
110 which are a portion of track 100 which is substantially
perpendicular to the longitudinal axis of plunger 30. Track 100
also preferably comprises a plurality of detent tabs 104 which are
aligned substantially parallel to the longitudinal axis of plunger
30. In the first position the slider 20 is positioned such that the
follower 28 of the slider 20 does not interact with the track 100
of plunger 30. A filling needle is attached to the syringe barrel.
The first position of slider as described above is the filling
position and allows syringe 11 to be used as a conventional
syringe; however, in usage of delivery device 10 in the first
position of slider 20 primarily serves to fill the syringe using
either a filling needle or needle assembly 12 without any
substantial interference. Thus the plunger 30 may enter the barrel
40 along the length of the plunger 30 with no stoppages. If a
filling needle is employed, the filling needle is removed from the
barrel and needle assembly 12 is attached in preparation for the
unit dosing, after the entire dose is drawn into the barrel 40. In
preparation for unit dosing, the slider 20 is moved to a second
position in the direction of arrow 114, upon which the follower 28
is now within track 100.
[0027] Preferably, the follower 28 is positioned within the track
at the starting position 107 (shown in FIG. 9B) which serves as an
area to purge the syringe of air and set the plunger to the first
unit dose, however, the follower may be placed directly in one of
the plurality of units. The health care professional then moves the
plunger 30 distally, in the direction of arrow 115. The follower 28
is then directed to position "P0" at the proximal end of starting
position 107 via the angled wall 112 of track 100. The dose
expelled during this phase is optionally discarded. Alternatively,
the dose created during this phase is injected into the patient.
When the follower reaches position "P0" labeled as reference
numeral 119, the follower 28 abuts abutting wall 110 and distal
movement of the plunger is prevented. Position "P0" is the initial
position of unit dosing which corresponds to position labeled "P1"
identified by reference numeral 120 in FIG. 8. As distal movement
of the plunger is prevented by abutting wall 110, the health care
professional depresses the slider button 21 to move slider 20
radially in the direction of arrow 114, and reset the dose divider
13. Preferably, follower 28 abuts detent tab 104 which provides
resistance to follower 28, thus the slider 20 to move in the radial
direction; however, since follower 28 is flexibly mounted on beam
27 of slider 20, movement in the radial direction is possible with
deflection of the follower. As discussed previously, a designed
deformation of the follower, track or combinations thereof would
serve the same purposes. The resistance of the deflection of
follower 28 over detent tab 104 is preferably selected so that it
gives tactile feedback to the health care professional that the
next dose is ready to be delivered. Optionally, the follower 28,
beam 27 and detent tab 104 dimensions are selected such that an
audible click is heard by the health care professional.
[0028] As the follower 28 has now passed detent tab 104, the
follower is now at position labeled "P2" identified by reference
numeral 121 at the distal end of unit 101. Thus, this is the start
of the unit 101 and the start of the delivery of a unit dose. The
health care professional inserts the needle 56 into the patient and
depresses the plunger 30, preferably by push button 32. As the push
button 32 is depressed and the plunger 30 begins to move distally,
and since the follower 28 is contained within track 100, the
follower 28 travels along the angled portion 102 of track 100.
Angled wall 112 biases follower 28 in the direction of arrow 116,
and therefore moves slider 120 in the direction of arrow 116.
Angled wall 112 serves to cam the follower into another position.
At the approximate middle of the unit 101, the follower is now at
position labeled "P3" identified by reference numeral 122, in which
as the follower 120 travels along the angled portion 102 of track
100, the slider 20 is radially moved proportionally to the distal
movement of the plunger 30, dependant on the angle of angled
portion 102. As the follower 28 reaches position labeled "P1'"
identified by reference numeral 120' at the proximal end of unit
101, the follower 28 reaches a stop point which is the beginning of
the adjacent unit 101, wherein the plunger 30 is prevented from
moving distally by the interaction of follower 28 and abutting wall
110. Thus, the resetting of the dose divider process is repeated to
bring the follower to position labeled "P2'" which is labeled with
reference numeral 121'. The practitioner then moves the needle to a
new injection site and repeats the process of injection. This
process continues until the entire dose is delivered in a series of
unit doses. Optionally, the last unit dose has the follower 28
traveling within the ending portion 108 (shown in FIG. 9A) of track
100. In the ending portion 108 there is a large space of track 100
which allows follower 28 of slider 28 to move radially, which
indicates to the health care professional that the last dose is
delivered. The volumetric unit doses are comprised of the axial
distance between positions P2 and P2' multiplied by the area of the
cross section of the barrel 40. Preferably, the unit doses are
equally spaced, although it would be possible to pre-select unit
doses of varying volumes by selecting the spacing of P2 and P2''
for each unit 101 of track 100.
[0029] Now turning to FIG. 11A-B and FIG. 12 which shows an
alternate embodiment of dose divider which is similar to the dose
divider as described above. The dose divider of this embodiment
contains similar features and operates similarly to the dose
divider as described above with a modification in the track and
configuration of the unit and the addition of a biasing feature
between the slider and the clip. Plunger 30 of this embodiment
comprises track 200 having unit 201. Furthermore clip 600 has
slider 220 integrally formed therein. Clip 600 is slide onto flange
41 of barrel 40 as described above. Clip 600 also comprises
stabilizer 255 which serves to stabilize plunger 30 and slider 220,
as well as secure the clip 600 onto the flange 41, or combinations
of these purposes. Slider 220 further comprises follower 280. In
this embodiment follower 280 is a ratchet-like protrusion on slider
220, although may have other shapes, such as any of the embodiments
described herein. Slider 220 is biased radially outward by biasing
means 250. In this embodiment biasing means 250 are a series of
integrally molded leaf springs 251. Biasing means 250 is designed
to place a bias to slider 220 and therefore follower 280 in the
operation of the device. Slider 220 also contains optional push
button 210. Although Slider 220 is integrally formed with clip 600,
slider 220 is able to be slid in a radial direction with respect to
the longitudinal axis of barrel 40. Furthermore, substantial
proximal and or distal movement of follower 280 with respect to
barrel 40 is substantially prevented by the design of slider 220,
clip 600 and connection methods employed. Optionally, all of the
aspects of Clip 600 described herein would be readily integrally
formed into barrel 40, however, for ease of using glass barrels,
clip 600 is a separate component, however since the connection of
clip 600 to barrel 40 is a connection which prevents any
substantial distal or proximal movement of clip 60 to barrel 40,
they (clip 60, barrel 40) function as one.
[0030] Now turning to FIG. 12, as the follower 280 has three
positions (P1, P2, P3) which will be described below. At the
beginning of a unit dose, follower is located as position "P1." In
order to begin the dosing sequence, the health care professional
depresses button 210 which applies a bias to slider 220 in the
direction of arrow 114 and thus forces follower 280 to pass now
passed detent tab 104, the follower 280 is now at position labeled
"P2" identified by reference numeral 121 at the distal end of unit
201. The health care professional inserts the needle 56 into the
patient and depresses the plunger 30, preferably by push button 32.
As the push button 32 is depressed and the plunger 30 begins to
move distally in the direction of arrow 115, and since the follower
280 is contained within track 200, the follower 28 travels along
track 200. However, since there is a bias applied by bias means 250
applied to the slider 220 and follower 280 in the direction in the
direction of arrow 202, and therefore moves slider 220 in the
direction of arrow 202. At the approximate middle of the unit 201,
the follower is now at position labeled "P3" identified by
reference numeral 122, in which as the follower 280 travels along
track 200, the slider 220 is biased by bias means 250 into the
capture portion 202 of track 200. As the follower 280 reaches
position labeled "P1'" identified by reference numeral 120' at the
proximal end of unit 201, the follower 280 reaches a stop point
which is the beginning of the adjacent unit 201, wherein the
plunger 30 is prevented from moving distally by the interaction of
follower 28 and abutting wall 110. Thus, the resetting of the dose
divider process is repeated to bring the follower to position in
which the plunger may be moved distally as described above. The
practitioner then moves the needle to a new injection site and
repeats the process of injection. This process continues until the
entire dose is delivered in a series of unit doses. Optionally, the
last unit dose has the follower 280 traveling within the ending
portion of track 200, similarly as described in the previous
embodiment. As in the previous embodiment, the volumetric unit
doses are comprised of the axial distance between positions P2 and
P2' multiplied by the area of the cross section of the barrel 40.
Preferably, the unit doses are equally spaced, although it would be
possible to pre-select unit doses of varying volumes by selecting
the spacing of P2 and P2'' for each unit 201 of track 200.
[0031] Now turning to FIG. 7A which shows an alternate embodiment
of dose divider 1300 which uses a radially moving collar 160 having
a cantilevered beam 270 which serves as a pawl having follower 280.
The collar 160 is slidable from a first position to a second
position on the flange of the barrel 40. Furthermore, the plunger
30 of the device is ratcheted with a plurality of spaced detents
1110. Detents 1110 are formed into units 1010. In the first
position collar 160 is positioned such that the follower 280 of the
cantilevered beams 270 do not interact with the detents 1110 of the
plunger 30. A filling needle is attached to the syringe barrel. The
first position is the filling position and allows the syringe 11 to
be used as a conventional syringe; however, in the usage of this
device, the first position of collar 160 primarily serves to fill
the syringe using a filling needle without interference by the
dosing device 1300. The filling needle is removed from the barrel
and a needle assembly 12. The collar 160 is moved to a second
position on the flange of barrel 40. In the second position the
collar 160 is positioned such that the follower 280 of the
cantilevered beams 270 interfere with the detents 1110 of the
plunger 30. This is the discrete injection position and allows the
syringe 11 to be used as a multiple repeat dose device. The
practitioner inserts the needle into the patient and depresses the
plunger. As the plunger is depressed, the follower 280 interacts
with the detents 1110 which provide for tactile feedback to the
health care professional that the discrete intermediate dosage has
been delivered. The health care professional then moves the needle
to a new injection site and repeats the process. This process
continues until the entire dose is delivered.
[0032] Now turning to FIG. 3 and FIG. 10, the needle assembly 12
includes a needle cannula 56 located at the distal end of the hub
50. In the embodiment depicted in FIGS. 3 and 10, needle 56 is
inserted into hub 50 defined at that distal end of needle assembly
12 in a manner known to those skilled in the art. For example,
needle 56 may be secured using a friction fit, snap fit, suitable
adhesive, solvent weld, or other now known or hereafter developed
means of securing a needle to a hub. Sheath 80 is slidably engaged
to hub 50 by ribs 53, 54. In one embodiment rib 54 has detents
which cooperate with detenting means 82 to lock sheath 80 in at
least one of two or more positions. In the intradermal embodiment
of needle assembly 12, hub 50 includes a specifically designed skin
engaging surface 57, which cooperates with needle 56, extending
from the distal end of surface 57 from 0.3 mm to 3 mm, preferably
0.5 mm to 1.5 mm.
[0033] FIG. 10 shows a cross section of needle assembly 12 attached
to distal end of barrel 40. Barrel 40 comprises collar 48 which
contains internal threads 49 which engage with external threads 58
of hub 50. Barrel 40 also comprises luer tip 46 which has a taper
of "L" degrees. Typically "L" is approximately between 1.5 and 2.0
degrees. Preferably "L" is approximately 1.75 degrees. Hub 50 also
has a corresponding taper within luer opening 51. Preferably, luer
opening 51 of hub 50 is adapted to only receive specialized luer
tip 46 of barrel 40. Luer opening 51 is designed to have a stepped
opening, such that standard luer tips of standard syringes will not
fully engage luer opening 51 and thus be un-usable with hub 50 of
needle assembly 12. Luer opening 51 is elongated and has a depth
dimension of D1+D2. Preferably, dimension D2 is selected such that
it is greater than the extension of standard luer tips. More
preferably, dimension D2 is selected such that it does not allow
engagement of threads 58 into standard luer lock barrels, but the
fact that hub proximal end 51 protrudes at distance D2 from threads
58, this does not allow engagement of the components. The interior
diameter between D1 and D2 has a discontinuity 59 of dimension D3
such that a step is formed at the interface between D1 and D2.
Typically D3 ranges from 0.05 mm to 0.15 mm, preferably
approximately 0.1 mm. Typically D1 ranges from 6 mm to 10 mm,
preferably approximately 8 mm. Typically D2 ranges from 4.5 mm to
8.5 mm, preferably approximately 6.5 mm. The location of the
discontinuity 59 is selected such that effective use of hub 50 on
standard luer tips is prevented. Preferably, the location of
discontinuity 59 is at the same location as threads 58 along hub
50. However, since the distal end of luer tip 46 is standard in
nature, luer tip 46 allows attachment of a standard luer needle
with no degradation in performance. As such, luer tip 46 allows
both use of a standard luer needle for filling and hub 50 of
specialized needle assembly 12 for injection.
[0034] Preferably inserted in the internal diameter of luer tip 46
is restrictor pin 92. Restrictor pin 92 is substantially
cylindrical and comprises a flattened portion 93 such that when
restrictor pin 92 is inserted into internal diameter of luer tip
46, the internal diameter is substantially but not completely
obstructed to form flow path 91. Preferably flow path 91 is sized
to enable effective filling of delivery device 10 and prevent
excessive shear forces on any substances delivered. Restrictor pin
92 also optionally comprises detent 94 which cooperates with
optional detent rib 44 within luer tip 46 which serves to retain
restrictor pin 92 in luer tip 46. Other methods may be used to
retain restrictor pin 92 in luer tip 46. Hub 50 has dead space 90
which is included of the overall dead space of the system. It may
be desirable to add a second restrictor pin within hub dead space
90, as well. Alternatively, an elongated restrictor pin of similar
design may be used in both spaces. Thus, restrictor pin 46 serves
to reduce the overall "dead space" of delivery device 10.
[0035] In use, a health care professional administering the
injection will unwrap the protective packaging from the vial. The
health care professional will then manually insert the medication
device into the vial in preparation for aspiration of medication
into barrel 40. If supplied as separate components, the health care
professional will then manually insert the syringe 11 into the
filling needle in preparation for aspiration of medication.
Alternatively, the filling needle and delivery device 10 are
pre-assembled in a kit supplied with needle assembly 12. In another
embodiment, all three components (needle assembly 12, syringe 40
and the filling needle are supplied in a kit. In another
embodiment, syringe 40 is pre-filled with the drug substance and no
filling is required. In another embodiment, syringe 40 is
pre-filled with a diluent. Optionally, at this point, a diluent is
injected in the medication vial. The healthcare professional then
aspirates the syringe with the medication from the medication vial
from syringe 11. The health care professional will then manually
remove the syringe 11 from the filling needle in preparation for
administration of the injection. The needle assembly 12 is then
attached to the device. In another embodiment, the filling needle
is the same needle as the needle assembly 12. Administration will,
in one embodiment, involve pressing the skin engaging surface 57 of
the hub 50 substantially perpendicular to a surface of the
patient's skin. The first unit dose of the drug substance will then
be injected using the plunger 30. As the plunger is depressed the
follower of the dose divider 13 follows the path of the track
100,200. The follower then reaches stop point 122. Upon completion
of the unit dose, the health care professional withdraws the needle
cannula from the patient's skin and prepares to reset the dose
divider. Optionally the health care professional prepares the next
injection site. The dose divider 13 is then reset in order to
deliver the next unit dose, which entails moving the follower to
start point 120. Preferably, the reset involves pushing a button on
the slider such that the follower is moved into the start point
120. This cycle is then repeated for the number of units along the
length of the plunger. Upon completion of the entire dose, the
health care professional withdraws the needle cannula from the
patient's skin and disposes the used injection device 10 in a
suitable container. Prior to disposal, the health care professional
optionally activates the shielding portion of delivery device by
sliding sheath 80 distally.
[0036] As will now be understood, the delivery device having
aspects of the invention may include a needle enclosure means which
encloses or conceals the needle cannula tip following injection and
which preferably cannot be retracted to prevent accidental needle
contact or reuse. In the embodiment shown in FIGS. 1 and 3, a
sheath 80 may be extended following injection and locked in place.
The assembly includes sheath 80 which locks in the extended
position, preventing contact with the needle by use of locking
means 82. Optionally arm 84 extends for the main portion of sheath
80 to aid in activation.
[0037] The invention has been described in an illustrative manner,
and it is to be understood that the terminology which has been used
is intended to be in the nature of words of description rather than
of limitation.
[0038] Obviously, many modifications and variations of the present
invention are possible in light of the above teachings. It is,
therefore, to be understood that within the scope of the appended
claims, wherein reference numerals are merely for convenience and
are not to be in any way limiting, the invention may be practiced
otherwise than as specifically described.
* * * * *