U.S. patent application number 13/789850 was filed with the patent office on 2013-07-25 for device for delivering a medicament.
This patent application is currently assigned to SHL GROUP AB. The applicant listed for this patent is SHL GROUP AB. Invention is credited to David DeSalvo, Lucio Giambattista, Carlos E. Guillermo.
Application Number | 20130190696 13/789850 |
Document ID | / |
Family ID | 40039846 |
Filed Date | 2013-07-25 |
United States Patent
Application |
20130190696 |
Kind Code |
A1 |
Guillermo; Carlos E. ; et
al. |
July 25, 2013 |
DEVICE FOR DELIVERING A MEDICAMENT
Abstract
A device for delivery of medicament, which device comprises an
elongated housing; a container (4) mounted within said housing and
adapted to contain liquid medicament; a stopper slidably arranged
within said container; and actuating means comprising a resilient
member (60), a driving means (50) having one end connected to the
stopper and a second end being operably connected to the resilient
member, retaining means (40) for releasably retaining said driving
means in a first position where said resilient member has an
accumulated energy, and activating means operably connected to said
retaining means for releasing said driving means to a second
position, upon actively operation by an user, such that said
accumulated energy is transferred to the driving means for driving
the stopper a predetermined distance within the container whereby
the medicament within said container i delivered characterized in
that the resilient member is a variable force spring adapted for
generating a predetermined sequence of at least two different force
profiles during the medicament delivery.
Inventors: |
Guillermo; Carlos E.;
(Atascadero, CA) ; Giambattista; Lucio; (East
Hanover, NJ) ; DeSalvo; David; (Lake Hiawatha,
NJ) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
SHL GROUP AB; |
Nacka Strand |
|
SE |
|
|
Assignee: |
SHL GROUP AB
NACKA STRAND
SE
|
Family ID: |
40039846 |
Appl. No.: |
13/789850 |
Filed: |
March 8, 2013 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12666963 |
Jun 13, 2010 |
8460245 |
|
|
PCT/EP2008/059493 |
Jul 19, 2008 |
|
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13789850 |
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60950770 |
Jul 19, 2007 |
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Current U.S.
Class: |
604/228 |
Current CPC
Class: |
A61M 5/3155 20130101;
A61M 2005/2013 20130101; A61M 5/31591 20130101; A61M 5/326
20130101; F16F 1/10 20130101; A61M 5/31515 20130101; A61M 5/2033
20130101; A61M 5/31563 20130101; F16F 1/027 20130101; A61M 5/46
20130101 |
Class at
Publication: |
604/228 |
International
Class: |
A61M 5/315 20060101
A61M005/315 |
Foreign Application Data
Date |
Code |
Application Number |
Dec 5, 2007 |
SE |
0702720-4 |
Claims
1. A device for delivery of medicament, comprising: an elongated
housing; a container mounted within the housing and having a
slidable stopper contained within and configured to contain a
liquid medicament; a plunger rod having a distal end and a proximal
end in contact with the stopper: at least two variable force
springs where one of the springs has a first end that is connected
to a carrier axially fixed to the housing and a second end that is
variably wound on the distal end of the plunger rod; and a retainer
pivotally arranged to the carrier and comprising a protrusion
positioned in a groove on the plunger rod for releasably retaining
the plunger rod in a first position where the variable force
springs have accumulated energy, where the retainer is configured
to release the plunger rod to a second position, upon active
operation by a user, such that the accumulated energy is
transferred to the plunger rod for driving the plunger rod and the
stopper a predetermined axial distance within the container whereby
the medicament within said container is delivered.
2. The device of claim 1 where the variable force springs are
arranged in a laminate configuration.
3. The device of claim 1 where at least one of the variable force
springs is adapted for generating a predetermined sequence of at
least two different force profiles during the medicament
delivery.
4. The device of claim 1 where each of the variable force springs
is adapted for generating a predetermined sequence of at least two
different force profiles during the medicament delivery.
5. The device of claim 3 where the variable force spring with the
at least two different force profiles has a profile where force
increases as the spring relaxes.
6. The device of claim 4 where all variable force springs have a
profile where force increases as the springs relax.
7. The device of claim 1 where each of the variable force springs
have a thickness t and are arranged relative to each other to have
an effective thickness equal to the sum of each t.
8. The device of claim 1 where the variable force springs are
arranged in a side-by-side configuration.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. patent
application Ser. No. 12/666,963, filed Jun. 13, 2010, which is a a
U.S. National Phase Application pursuant to 35 U.S.C. .sctn.371 of
International Application No. PCT/EP2008/059493 filed Jul. 19,
2008, which claims priority to U.S. Provisional Patent Application
No. 60/950,770, filed Jul. 19, 2007 and Swedish Patent Application
No. 0702720-4 filed Dec. 5, 2007. The entire disclosure contents of
these applications are herewith incorporated by reference into the
present application.
FIELD OF THE INVENTION
[0002] The present invention relates to a device for the delivery
of medicament to a patient. The device is adapted to be in a
medicament delivery state and in a medicament non-delivery state.
When the device is in a medicament delivery state, said device is
adapted to drive a plunger into a container containing the
medicament to be delivered, with a predetermined sequence of at
least two different force profiles.
BACKGROUND
[0003] Devices for the delivery of medicament in an automatic way
e.g. auto-injectors, are known as convenient and safe aids for
patients to administrate various drugs themselves. For safety
reasons, many devices for the delivery of medicament include covers
and other devices that protect users before and after use, for
example, from an injection needle Although different devices for
the delivery of medicament vary in their total feature sets, they
all have a mechanism that delivers the contents of a preloaded,
prefilled container automatically, i.e., without requiring a person
to manually force the contents within a container through a
delivery member e.g. a needle, a nozzle, into the patient.
[0004] Autoinjectors are described in U.S. Pat. No. 5,478,316 to
Bitdinger et al.; U.S. Pat. No. 7,112,187 to Karlsson; and U.S.
Pat. No. 7,125,395 to Hommann et al.; U.S. Patent Application
Publication No. 2007/0021720 to Guillermo; and International
Publication No. WO 2006/057604 Al by Olson, for example. The
automatic delivery mechanism in a device for the delivery of
medicament usually includes a compressed helical spring that drives
a plunger rod forward as the spring decompresses upon activation of
the device. In many cases, such springs work well. A fully
compressed helical spring provides a force that is large enough to
overcome the static friction between the plunger and the inner wall
of a container, so called break loose force, and the spring at its
full extension, which is often not at its full decompression,
provides a force that is large enough to complete the injection
stroke but causing the probability of the container breakage.
[0005] A challenge in the design of such springs is balancing the
need for sufficient force at the end of stroke against the need for
a not-too-large force during storage (when the spring is fully
compressed) that may overload the other components in the device.
Such other components may be made of plastics or similar materials
that have limited strengths.
[0006] Thus, the drive mechanism in such a device for the delivery
of medicament should meet the following simultaneous goals: 1)
exert enough force to overcome the stopper's "break loose" force
and initiate delivery of the medication, 2) exert enough force to
complete-the injection stroke, 3) meet goals 1) and 2) in an
acceptable time frame (usually a few seconds), and 4) exert a low
force during storage.
[0007] Rather than use typical helical springs, some delivery
devices use constant force springs. U.S. Pat. No. 5,478,316 cited
above describes such a device.
[0008] Although constant-force springs are better able than
compression helical springs to meet the design goals of such a
device, they also come up short. During the processing of a
prefilled container, the container is typically siliconized, i.e.,
given a coating of silicone, to ease the movement of the stopper
during delivery. The silicone can be applied in a few different
ways but all strive to distribute the silicone evenly--especially
at the end of the container nearest the delivery member. Usually
the silicone coating is thinner or lacking at the end of the
barrel, with the result that the stopper's glide force increases
towards.
[0009] Moreover, EP 0953122 A1 describes a coil spring of strip
material having two portions of a non-uniform width and wherein
each portion has a constant force characteristic. In the
application of said coil spring to an injection device, the spring
has a wide portion wound innermost which urges a syringe forwards
for auto-penetration i.e. the penetration of the needle into an
injection site, and a narrow portion which then takes over to eject
the dose i.e. the auto-injection. The impelling of the syringe
forwards has a greater force than that applied subsequently to a
stopper of the syringe.
[0010] Although a coil spring of strip material having portions of
a non-uniform width are better able than compression helical
springs to meet the design goals of an autoinjector, they also come
up with drawbacks. The design and the application of such a spring
as described in EP 0953122 A1 leads to the drawbacks of painful
penetration since a great force is used for this step, and of not
exerting enough force to overcome the break-loose force at the end
of the injection stroke.
SUMMARY
[0011] The object of the present invention is therefore to provide
an automatic medicament delivery device, which during medicament
delivery applies a predetermined sequence of at least two different
force profiles to a stopper, which ensures an optimal functionality
of said device.
[0012] The present invention lowers the risk of damaging the
container and/or the device during medicament delivery and reduces
the problems with plastic deformation of the plastic materials of
the delivery device in comparison with prior art automatic
medicament delivery devices.
[0013] With the present invention it also possible to set a
predetermined dose that is to be delivered in an easy and reliable
way.
[0014] The inventors have recognized that the problems caused by
typical compression helical springs and constant-force springs in
medicament delivery devices can be overcome by a variable-force
springs as described below.
[0015] These objects are accomplished with a delivery device
according to the preamble of the independent claim(s) provided with
the features according to the characterizing portions of the
independent claim(s). Preferred embodiments of the present
invention are set forth in the dependent claims.
[0016] According to a main aspect of the invention, it is
characterized by a device for delivery of medicament, which device
is adapted to comprise an elongated housing; a container mounted
within said housing and adapted to contain a liquid medicament; a
stopper slidably arranged within said container; and actuating
means comprising a resilient member, a driving means having one end
connected to the stopper and a second end being operably connected
to the resilient member, retaining means for releasably retaining
said driving means in a first position where said resilient member
has an accumulated energy, and activating means operably connected
to said retaining means for releasing said driving means to a
second position, upon actively operation by an user, such that said
accumulated energy is transferred to the driving means for driving
the stopper a predetermined distance within the container whereby
the medicament within said container is delivered characterized in
that the resilient member is a variable force spring adapted for
generating a predetermined sequence of at least two different force
profiles during the medicament delivery.
[0017] According to another aspect of the present invention, the
last force profile in said sequence is a profile where the force
increases.
[0018] According to a further aspect of the present invention, the
variable force spring is a coil spring of band material and wherein
the different force profiles are obtained by suitably adjusting the
material and/or the geometry and/or the natural radius and/or the
elastic modulus of the spring.
[0019] According to yet another aspect of the present invention,
the variable force spring has one end attached to a carrier which
is fixedly arranged to the housing and a second end, which is
variably wound, cradled on the second end of the driving means.
[0020] According to a further aspect of the present invention, the
activating means comprises a tubular member mounted to said housing
and at least one resilient means operably connected to said tubular
member, wherein said tubular member comprises an end portion
adapted to be retractable with respect to said housing against the
force of said resilient means when said end portion is pushed
against a delivery site and wherein said tubular member is adapted
to be urged in the direction of said end portion by the at least
one resilient means when said end portion is removed from the
delivery site.
[0021] According to yet another aspect of the present invention,
the device further comprises dose setting means adapted to be
operated in terms of predetermined steps when the device is in a
medicament non-delivery state, wherein the operation of the dose
setting means by one step increases the dose with a predetermined
step.
[0022] These and other aspects of the invention and advantages with
the present invention will become apparent from the following
detailed description and from the accompanying drawings.
BRIEF DESCRIPTION OF THE FIGURES
[0023] FIG. 1 illustrates a side cross-section view of a spring
that exerts a load,
[0024] FIG. 2 illustrates a top view of material that, if wound
into the shape of the spring depicted in FIG. 1,
[0025] FIG. 3 illustrates a top view of a variable-force spring
(VFS) that exerts a decreasing force and then an increasing
force,
[0026] FIG. 4 illustrates a view of an assembled medicament
delivery device that includes a VFS,
[0027] FIG. 5 illustrates a cross-section view of the medicament
delivery device as in FIG. 4,
[0028] FIG. 6, illustrates a cross-section of the medicament
delivery device in FIG. 4 in a medicament non-delivered state,
[0029] FIG. 7, illustrates a cross-section of the medicament
delivery device in FIG. 4 in a medicament delivered state,
[0030] FIG. 8, illustrates a cross-section of the medicament
delivery device in FIG. 4 in a final state.
DETAILED DESCRIPTION
[0031] In the present application, when the term "distal part/end"
is used, this refers to the part/end of the delivery device, or the
parts/ends of the members thereof, which under use of the delivery
device, are located the furthest away from the medicament delivery
site of the patient. Correspondingly, when the term "proximal
part/end" is used, this refers to the part/end of the delivery
device, or the parts/ends of the members thereof, which under use
of the delivery device, are located closest to the medicament
delivery site of the patient.
[0032] Traditional constant-force springs (CFSs) are coil springs
of band material and often used when an application demands a
smooth, even, uniform force through the entire expansion or
contraction of the spring, e.g., the entire travel of a plunger
through a container in a device for delivery of medicament e.g. an
autoinjector. CFSs are commercially available from John Evans'
Sons, Inc., Lansdale, Pa. 19446, USA, and Vulcan Spring & Mfg.
Co., Telford, Pa. 18969 USA, for example.
[0033] With CFSs, force, or load, is a function of material width,
thickness, and coil diameter. The load, which is directly
proportional to the material width in a CFS and not directly
proportional to material thickness, is given by the following
expression:
P=Ebt3 126,4R2 Eq. 1
in which P is the load, E is the material's Modulus of Elasticity,
b is the width of the material, t is the thickness of the material,
and R, is the natural radius. If the elastic modulus is given in
units of pounds per square inch (psi) and the material width,
thickness, and natural radius are given in inches, then the load is
given in pounds (lb).
[0034] Of course, other systems of units can be used.
[0035] The inventors have recognized that Eq. 1 can be used to
design a variable-force spring (VFS), which is also coil spring of
band material, having a predetermined profile of the load P by
suitably adjusting the material and/or the geometry of the spring.
Such VFSs are advantageous in devices for delivery of medicament
e.g. autoinjectors, especially VFSs that exert a predetermined
sequence of at least two different force profiles. There are three
types of force profiles. A first force profile is a profile where
the force decreases as the spring relaxes. A second force profile
is a profile where the force increases as the spring relaxes. A
third force profile is a profile where the force is constant as the
spring relaxes. As just one of many possible examples, changing the
radius of the coil, yielding a spring that exerts either increasing
or decreasing force, is advantageous in a wide range of products,
including devices for delivery of medicament.
[0036] The inventors have also recognized that besides or instead
of varying the natural radius, i.e., the radius of the coil, it is
possible to make VFSs that exert a predetermined sequence of at
least two different force profiles by modifying the other
parameters in Eq. 1, e.g., the physical shape of the spring.
Increasing, either the material's thickness or the width or both.
FIG. 1 is a side cross-section view of a spring that exerts a load
given by Eq. 1 and would be suitable for use in a device for
delivery of medicament e.g, an autoinjector for example. The arrow
in FIG. 1 indicates that an increasing force is needed to move the
end of the spring further toward the right in the figure while the
coil at the left remains stationary.
[0037] FIG. 2 is a top view of material that, if wound into the
shape of the spring depicted in FIG. 1 (except with the coil on the
right in FIG. 3), would yield a spring that generates an increasing
force as the spring relaxed. The varying width of the material will
be noted in FIG. 2 as it is that variation that produces the
desired load profile. The arrow in FIG. 2 indicates the direction
of increasing force.
[0038] It will be understood that the parameters in Eq. 1 can be
manipulated in various ways as necessary for the application of the
VFS. For example, besides or instead of varying the width of the
material, as depicted in FIG. 2, it is possible to vary the
material's thickness and/or the elastic modulus. It will be noted
that the load exerted by a VFS increases more by doubling the
thickness than by doubling the width. The elastic modulus in
different portions of the material can be varied in many ways, for
example by selectively working the material in such portions,
laminating other materials onto a base material in such portions,
etc. Application requirements and manufacturing factors may
indicate which parameter to vary, and such variation may be changed
on a case-by case basis. For example, FIG. 3 is a top view of a VFS
that exerts a decreasing force and then an increasing force. Thus,
this is a VFS that exerts a predetermined sequence of at least two
different force profiles.
[0039] Although it may be common to adjust the parameters for a new
spring design, it is not common to adjust the parameters on each
individual spring. The VFSs described above are advantageous in
many applications. For example in devices for delivery of
medicament e.g. autoinjectors having containers as syringes or
cartridges pre-filled with liquid medicaments, where a variable
force spring enables a predetermined sequence of at least two
different force profiles applied to the stopper when the medicament
is being delivered for overcoming problems due to siliconization
profiles as at the end of the delivery stroke and/or for enabling a
customized therapy as a delivery having multiple predetermined
sequences of at least two different force profiles different force
profiles. It should also be understood that variations in force can
arise from other sources besides siliconization. The VFSs described
above enable the spring forces generated to match or compensate the
break-loose and glide force profiles within the container generated
by different manufacturers and processes better than conventional
springs.
[0040] FIG. 4 is a view of an assembled medicament delivery device
that includes a VFS. FIG. 5 is a cross-section of the medicament
delivery device as in FIG. 4, and FIGS. 6, 7, and 8 are
cross-sections of the medicament delivery device in different
states during use, which is described below.
[0041] As seen in FIG. 5, a device for delivery of medicament e.g.
an autoinjector, comprises an elongated housing 1; a cap 2 mounted
in the proximal end of the housing; a container 4 like a cartridge
being adapted to receive a delivery member, or like a syringe,
mounted within said housing and adapted to contain a medicament; a
stopper slidably arranged within said container and actuating means
for causing said stopper to slide with respect to said housing when
the device is actuated from its medicament non-delivery state to
its medicament delivery state. The actuating means comprises a
resilient member which is a VFS 60; a VFS carrier 30, a driving
means 50 like a plunger rod having one end connected to the stopper
and a second end being operably connected to the VFS; retaining
means 40 like a latch for releasably retaining said driving means
in a first position where said VFS has an accumulated energy; and
activating means 10 like a needle shield or like a button slidably
positioned inside the housing and operably connected to said
retaining means for releasing said driving means to a second
position, upon actively operation by an user, such that said
accumulated energy is transferred to the plunger rod for driving
the stopper a predetermined distance with a predetermined sequence
of at least two different force profiles whereby the medicament
within said container is expelled, and wherein said activating
means also comprises at least one resilient means 17 which function
will be described below.
[0042] In a preferred embodiment, the container 4 comprises a
delivery member in its proximal end and the cap 2 comprises a
shield for protecting the delivery member. Moreover, the container
4 preferably comprises a flange at its distal end which abuts a
periphery surface of a container housing 3 for preventing movement
of the container.
[0043] In the preferred embodiment, the activating means is
arranged as a tubular member 11. A portion of said tubular member
extends outside the housing 1 towards the proximal end of the
device completely covering the delivery member when the device is
in a medicament non-delivery state. When the delivery device is
arranged as an injector, then a penetration depth sleeve 12 is
suitable arranged to the proximal end of the tubular member 11 for
allowing the user to adjust the penetration depth of a needle. An
outwardly annular ledge 13 extending radially from the distal end
of the tubular member is arranged abutting a ledge 5 on the inner
surface of the housing when the device is in a medicament
non-delivery state. Further, the activating means also comprises
two tongues 14 extending longitudinally towards the distal end of
the device from the outwardly annular ledge 13. Said tongues 14
comprises on its outer surface a number of longitudinally
equidistant ledges 15 which are adapted to engage corresponding
grooves provide on the inner surface of a selector ring 20 when a
predetermined dose of medicament to be delivered has been selected
by the user. One of the tongues 14 comprises a tongue extension 16
extending towards the distal end of the device such that when the
device is actuated from the medicament non-delivery state to the
medicament delivery state, the tongue extension 16 passes through a
through hole (not shown) which is arranged on a circumferential
surface 21 of the selector ring 20.
[0044] In the preferred embodiment of the device at least one
resilient means 17, two constant force springs, is arranged. These
springs can also be replaced by another kind of resilient means
e.g. a coil spring, a spiral spring. The wound ends of the spring
17 are cradle within the outwardly annular ledge 13 and the other
end of the spring is secured to the housing.
[0045] In the preferred embodiment of the device, a dose setting
means comprises at least one longitudinally stepped dose groove 51
with an end wall 53 arranged on the plunger rod 50. At least one of
the longitudinally stepped dose grooves 51 is operably connected to
an inwardly protrusion 22 arranged on a coaxial through hole on the
circumferential surface 21 of the selector ring 20 wherein the
plunger rod 50 is arranged to pass through. The distance between
each end wall 53 and said protrusion 22 corresponds to a
predetermined dose.
[0046] The proximal end of the plunger rod is arranged to be in
contact with the stopper inside the container and the distal end
the plunger rod is saddle formed for cradling the wound end of the
VFS 60. The other end of the VFS is secured to the VFS carrier 30
which is fixedly arranged to inner surface of the housing 1. The
retaining means 40 is pivotally arranged to the VFS carrier and
comprises a protrusion 41 arranged to be in contact with a groove
52 of the plunger rod for holding the device in a medicament
non-delivery state. The VFS carrier also comprises a through hole
for allowing the plunger rod to pass through.
[0047] Before use, as seen in FIG. 6, the cap 2 is removed from the
device and when the device is arranged as an injector, the
penetration depth of the needle is set by handling the penetration
depth sleeve 12 e.g. by pulling.
[0048] In the preferred embodiment the dose is set by operating
i.e. rotating the selector ring 20 whereupon the protrusions 22
slides over the longitudinally stepped dose groove 51. Each time
one of the protrusions 22 slides over the groove 51, the dose is
predetermined increased. The set dose is indicated for the user by
means of a dose indicating printing provided e.g. along the
circumference of the exterior surface of the selector ring.
[0049] The delivery device is now ready to be set in a medicament
delivery state as seen in FIG. 7. This is accomplished by pushing
the tubular member 11 against a delivery site whereby when the
device is arranged as an injector, the needle penetrates into the
delivery site a predetermined depth and whereby the wound end of
the constant force springs 17 rotates in the outwardly annular
ledge 13 as the springs unravels. This movement is sufficient to
displace the tongue extension 16 towards the distal end of the
device, passing through the through hole which is arranged on the
circumferential surface 21 of the selector ring 20 for pushing and
thereby pivoting the retaining means 40. The pivoting of the
retaining means 40 causes its protrusion 41 to come out of contact
from the groove 52 arranged on the plunger rod 50. The plunger rod
50 is urged forwardly as the wound end of the VFS 60 rotates within
the saddle of the plunger rod. The plunger rod now urges the
stopper inside the container towards the proximal end of the device
with a predetermined sequence of at least two different force
profiles as fluid is displaced from the container through the
delivery member. The movement of the plunger rod continues until
the protrusion 22 of the selector ring engages the end wall 53 of
the selected groove 51 on the plunger rod.
[0050] Upon completion of the medicament delivery, the device is
withdrawn from the delivery site and set in a final state as seen
in FIG. 8. The activating means moves towards the proximal end of
the device under the force of the springs 17 for covering the
delivery member and the activating means is locked.
[0051] In a second embodiment, the activating means is arranged as
a button (not shown) adapted for pivoting the retaining means 40.
The pivoting of the retaining means 40 causes its protrusion 41 to
come out of contact from the groove 52 arranged on the plunger rod
50.
[0052] However, even though the present invention has been
described and illustrated in detail, said description and said
illustrations shall be regarded as being non limited, since it will
be appreciated that only the currently preferred embodiments have
been shown.
* * * * *