U.S. patent application number 14/403801 was filed with the patent office on 2015-04-16 for syringe.
The applicant listed for this patent is Andrew Bryant, Heinrich Buettgen, Wolfgang Papst, Marie Picci. Invention is credited to Andrew Bryant, Heinrich Buettgen, Wolfgang Papst, Marie Picci.
Application Number | 20150105734 14/403801 |
Document ID | / |
Family ID | 48577723 |
Filed Date | 2015-04-16 |
United States Patent
Application |
20150105734 |
Kind Code |
A1 |
Bryant; Andrew ; et
al. |
April 16, 2015 |
SYRINGE
Abstract
The invention provides a syringe for use in an ophthalmic
injection. The syringe comprises a body, a stopper and a plunger.
The body comprises an outlet at an outlet end and the stopper is
arranged within the body such that a front surface of the stopper
and the body define a variable volume chamber from which a fluid
can be expelled though the outlet. The plunger comprises a plunger
contact surface at a first end and a rod extends between the
plunger contact surface and a rear portion. The plunger contact
surface is arranged to contact the stopper but not couple thereto,
such that the plunger can be used to force the stopper towards the
outlet end of the body, reducing the volume of the variable volume
chamber, but not to move the stopper away from the outlet end.
Inventors: |
Bryant; Andrew; (Reinach,
CH) ; Buettgen; Heinrich; (Rheinfelden, CH) ;
Papst; Wolfgang; (Eschbach, DE) ; Picci; Marie;
(Ranspack-le-bas, FR) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Bryant; Andrew
Buettgen; Heinrich
Papst; Wolfgang
Picci; Marie |
Reinach
Rheinfelden
Eschbach
Ranspack-le-bas |
|
CH
CH
DE
FR |
|
|
Family ID: |
48577723 |
Appl. No.: |
14/403801 |
Filed: |
May 30, 2013 |
PCT Filed: |
May 30, 2013 |
PCT NO: |
PCT/EP2013/061215 |
371 Date: |
November 25, 2014 |
Current U.S.
Class: |
604/218 ;
206/438; 29/428 |
Current CPC
Class: |
A61P 27/02 20180101;
A61M 5/28 20130101; A61M 2005/3139 20130101; A61M 5/3137 20130101;
A61M 2005/3104 20130101; A61M 5/31513 20130101; A61M 2005/31508
20130101; A61M 5/001 20130101; A61F 9/0017 20130101; Y10T 29/49826
20150115; A61P 43/00 20180101; A61M 5/31505 20130101 |
Class at
Publication: |
604/218 ;
206/438; 29/428 |
International
Class: |
A61F 9/00 20060101
A61F009/00 |
Foreign Application Data
Date |
Code |
Application Number |
Jun 1, 2012 |
EP |
12170628.7 |
Claims
1. A syringe, the syringe (1) comprising a body (2), a stopper (10)
and a plunger (4), the body (2) comprising an outlet (12) at an
outlet end (14) and the stopper (10) being arranged within the body
(2) such that a front surface (16) of the stopper (10) and the body
(2) define a variable volume chamber (18) from which a fluid (20)
can be expelled though the outlet (12), the plunger (4) comprising
a plunger contact surface (22) at a first end (24) and a rod (26)
extending between the plunger contact surface (22) and a rear
portion (25), characterized in that the stopper (10) provides a
sealing function by defining the rear of the variable volume
chamber (18) with a fluid tight seal and the plunger contact
surface (22) arranged to contact the stopper (10) but not couple
thereto, such that the plunger (4) can be used to force the stopper
(10) towards the outlet end (14) of the body (2), reducing the
volume of the variable volume chamber (18), but not to move the
stopper (10) away from the outlet end (14)
2. A syringe as claimed in claim 1, in which the plunger contact
surface (22) is a substantially planar disc and the plunger contact
surface (22) contacts a rear surface (60) of the stopper (10).
3. A syringe as claimed in claim 1 in which the rod (26) comprises
at least one rod shoulder (32) directed away from the outlet end
(14) and the syringe (1) includes a backstop (6) arranged at a rear
portion of the body (2), the backstop (6) including a backstop
shoulder (34) directed towards the outlet end (14) to cooperate
with the rod shoulder (32) to substantially prevent movement of the
plunger rod (26) away from the outlet end (14) when the backstop
shoulder (34) and rod shoulder (32) are in contact.
4. A syringe as claimed in claim 3, in which the rod shoulder (32)
is arranged within the external diameter of the rod (26).
5. A syringe as claimed in claim 3, in which the rod shoulder (32)
comprises a substantially disc shaped portion on the rod (26).
6. A syringe as claimed in claim 3, in which the backstop (6) is
removable from the syringe (1).
7. A syringe as claimed in claim 6, in which the backstop (6) is
configured to substantially sandwich terminal flanges of the body
(2).
8. A syringe as claimed in claim 3, in which, when arranged with
the plunger contact surface (22) in contact with the stopper (10)
and the variable volume chamber (18) is at its intended maximum
volume there is a clearance of no more than 2 mm between the rod
shoulder (34) and backstop shoulder (32).
9. A syringe as claimed in claim 1, in which the variable volume
chamber (18) has an inner diameter of between 4 mm and 5 mm.
10. A syringe as claimed in claim 1, in which the syringe (1) is
dimensioned so as to have a nominal maximum volume of between 0.4
ml and 0.6 ml.
11. A syringe as claimed in claim 1, in which the syringe (1) is an
ophthalmic syringe and the variable volume chamber (18) is filled
with an injectable medicament comprising a medicament suitable for
the treatment of an ocular disease and the outlet (12) is
reversibly sealed.
12. A syringe pack comprising a sealed package and a sterile
syringe (1) as claimed in claim 1.
13. A method of assembling a syringe, the method comprising the
steps of: i) providing a body (2) and a stopper (10), the body (2)
comprising an outlet (12) at an outlet end (14) and the stopper
(10) being arranged within the body (2) such that a front surface
(16) of the stopper (10) and the body (2) define a variable volume
chamber (18) from which a fluid (20) can be expelled though the
outlet (12), the stopper (10) providing a sealing function by
defining the rear of the variable volume chamber (18) with a fluid
tight seal, the outlet (12) being releasably sealed and the
variable volume chamber (18) containing a medicament; and ii)
providing a plunger (4) comprising a plunger contact surface (22)
at a first end and a rod (26) extending between the plunger contact
surface (22) and a rear portion (25) and arranging the plunger
contact surface (22) and at least part of the plunger (4) within
the body (2) without coupling the plunger (4) to the stopper
(10).
14. A method as claimed in claim 13, in which the variable volume
chamber (18) contains an injectable medicament comprising a
medicament suitable for the treatment of an ocular disease.
15. A method as claimed in claim 13, in which the rod comprises at
least one rod shoulder directed away from the plunger contact
surface and a backstop is provided, the backstop including a
backstop shoulder directed towards the outlet end, the backstop is
coupled to the syringe body after the plunger has been arranged in
the body and the rod shoulder is arranged between the outlet end
and the backstop shoulder.
16. A method as claimed in claim 13, in which the plunger rod is
dropped into the syringe body.
17. A plunger suitable for use in the syringe of claim 1.
18. A plunger suitable for the method of claim 13.
19. A syringe as claimed in claim 11 wherein the medicament
comprises a VEGF antagonist.
20. A syringe as claimed in claim 19 wherein the VEGF antagonist
comprises ranibizumab.
Description
[0001] The present invention relates to a syringe, particularly to
a small volume syringe such as a syringe suitable for ophthalmic
injections. The invention also extends to a method of assembling
such a syringe.
[0002] Many medicaments are delivered to a patient in a syringe
from which the user can dispense the medicament. If medicament is
delivered to a patient in a syringe it is often to enable the
patient, or a caregiver, to inject the medicament. It is important
for patient safety and medicament integrity that the syringe and
the contents of that syringe are sufficiently sterile to avoid
infection, or other, risks for patients. Sterilisation can be
achieved by terminal sterilisation in which the assembled product,
typically already in its associated packaging, is sterilised using
heat or a sterilising gas.
[0003] For small volume syringes, for example those for injections
into the eye in which it is intended that less than about 0.1 ml of
liquid is to be injected, the sterilisation can pose difficulties
that are not necessarily associated with larger syringes. Changes
in pressure, internal or external to the syringe, can cause parts
of the syringe to move unpredictably, which may alter sealing
characteristics and potentially compromise sterility. Incorrect
handling, including assembly, of the syringe can also pose risks to
product sterility.
[0004] The present invention provides a syringe, the syringe
comprising a body, a stopper and a plunger, the body comprising an
outlet at an outlet end and the stopper being arranged within the
body such that a front surface of the stopper and the body define a
variable volume chamber from which a fluid can be expelled though
the outlet, the plunger comprising a plunger contact surface at a
first end and a rod extending between the plunger contact surface
and a rear portion, the plunger contact surface arranged to contact
the stopper but not couple thereto, such that the plunger can be
used to force the stopper towards the outlet end of the body,
reducing the volume of the variable volume chamber, but not to move
the stopper away from the outlet end.
[0005] Providing a plunger which does not couple to the stopper
reduces the chances for incorrect handling of the syringe as the
plunger can be withdrawn from the syringe without movement of the
stopper away from the outlet end. This prevents a user from
accidentally moving the plunger (and therefore a stopper connected
thereto) and causing non-sterile air (or other fluid) to be drawn
into the syringe, or causing movement of the stopper to a
non-sterile area. It has also been found that creating a connection
between a plunger to a stopper during assembly, using for example a
screwing action or a push-fit action, can distort the stopper in an
unpredictable manner which may compromise the sealing and/or
sterility of the final product, or may increase pressure in the
variable volume chamber which could cause fluid leakage from the
outlet end.
[0006] The body of the syringe may be a substantially cylindrical
shell, or may include a substantially cylindrical bore with a
non-circular outer shape. The outlet end of the body includes an
outlet through which a fluid housed within the variable volume
chamber can be expelled as the volume of said chamber is reduced.
The outlet may comprise a projection from the outlet end through
which extends a channel having a smaller diameter than that of the
variable volume chamber. The outlet may be adapted, for example via
a luer lock type connection, for connection to a needle or other
accessory such as a sealing device which is able to seal the
variable volume chamber, but can be operated, or removed, to unseal
the variable chamber and allow connection of the syringe to another
accessory, such as a needle. Such a connection may be made directly
between the syringe and accessory, or via the sealing device. The
body extends along a first axis from the outlet end to a rear
end.
[0007] The body may be made from a plastic material or from glass,
or from any other suitable material and may include indicia on a
surface thereof to act as an injection guide.
[0008] The stopper may be made from rubber, silicone or other
suitable resiliently deformable material. The stopper provides a
sealing function by defining the rear of the variable volume
chamber with a fluid tight seal which also provides a sterility
seal. The stopper may be substantially cylindrical and the stopper
may include one or more circumferential ribs around an outer
surface of the stopper, the stopper and ribs being dimensioned such
that the ribs form a substantially fluid tight seal with an
internal surface of the syringe body. The front surface of the
stopper may be any suitable shape, for example substantially
planar, or substantially conical. The stopper may be substantially
solid or may include recesses. The rear surface of the stopper may
include a substantially central recess which may be any shape
provided the sealing function of the stopper is not compromised.
Said central recess may be substantially cylindrical in shape or
said central recess may include an initial bore having a first
diameter, the initial bore leading from the rear surface into the
stopper to an inner recess having a second diameter, the second
diameter being larger than the first diameter. Such a central
recess could be used to connect a plunger to the stopper using a
snap fit feature in a known manner. Such a design allows a
substantially standard stopper design to be used and this can
reduce the parts cost for the syringe. Also, it is noted that
removing material from the central portion of the stopper, where it
is not needed for the stopper to function as required, reduces the
stopper weight and reduces the amount of material needed to
manufacture the stopper. The stopper may be substantially
rotationally symmetric about an axis through the stopper.
[0009] The plunger comprises a plunger contact surface and
extending from that a rod extends from the plunger contact surface
to a rear portion. The rear portion may include a user contact
portion adapted to be contacted by a user during an injection
event. The user contact portion may comprise a substantially disc
shaped portion, the radius of the disc extending substantially
perpendicular to the axis along which the rod extends. The user
contact portion could be any suitable shape. The axis along which
the rod extends may be the first axis, or may be substantially
parallel with the first axis.
[0010] The plunger contact surface is adapted to make contact with
the rear surface of the stopper, but not couple thereto. The
plunger contact surface may be substantially planar and may be
substantially circular in shape. The plunger contact surface may be
substantially circular with an outer diameter less than the
internal diameter of the body. The diameter of the plunger contact
surface may be substantially equal to the diameter of the rear
surface of the stopper with which it is to make contact. The
plunger contact surface may be adapted to present a substantially
rotationally symmetrical surface to the rear surface of the stopper
as this assists in providing a repeatable and evenly distributed
force to the stopper during use which can help to prevent
distortions. The plunger contact surface may not be planar and may
comprise an annular contact surface to contact the stopper at or
adjacent an out edge thereof. The plunger contact surface may
comprise a plurality of arms which extend from the plunger rod to
make contact with the stopper. The plunger contact surface may be
substantially rotationally symmetrical in any of the above, or
other, embodiments.
[0011] The rod may have a round or cross-form cross-section. A
cross-form cross section may be formed from ribs extending along at
least part of the rod. The ribs may extend substantially parallel
with the axis along which the rod extends. The cross-form cross
section provides rigidity to the rod without significantly
increasing manufacturing complexity.
[0012] The rod may be manufactured from any suitable material, or
combination of materials, and in one embodiment is made from a
plastic material. The rod may be substantially rigid under expected
use conditions. Although some flexing of the materials in the
plunger is unavoidable in a bulk manufactured product, it is
advantageous that the rod cannot flex significantly during use,
particularly for low volume, accurate, injections as any flexing
could lead to unpredictable dosing results.
[0013] The syringe may include a backstop arranged at a rear
portion of the body. The backstop may be removable from the
syringe. If the syringe body includes terminal flanges at the end
opposite the outlet end the backstop may be configured to
substantially sandwich terminal flanges of the body as this prevent
movement of the backstop in a direction parallel to the first
axis.
[0014] The rod may comprise at least one rod shoulder directed away
from the outlet end and the backstop may include a backstop
shoulder directed towards the outlet end to cooperate with the rod
shoulder to substantially prevent movement of the rod away from the
outlet end when the backstop shoulder and rod shoulder are in
contact. Restriction of the movement of the rod away from the
outlet end can help to maintain sterility during terminal
sterilisation operations, or other operations in which the pressure
within the variable volume chamber or outside the chamber may
change. During such operations any gas trapped within the variable
volume chamber, or bubbles that may form in a liquid therein, may
change in volume and thereby cause the stopper to move. Movement of
the stopper away from the outlet could result in the breaching of a
sterility zone created by the stopper. This is particularly
important for low volume syringes where there are much lower
tolerances in the component sizes and less flexibility in the
stopper. The term sterility zone as used herein is used to refer to
the area within the syringe that is sealed by the stopper from
access from either end of the syringe. This may be the area between
a seal of the stopper, for example a circumferential ridge, closest
to the outlet and a seal of the stopper, for example a
circumferential ridge, furthest from the outlet. The distance
between these two seals defines the sterility zone of the stopper
since the stopper is installed into the syringe barrel in a sterile
environment.
[0015] As noted above, a terminal sterilisation process may be used
to sterilise the complete article and such a process may use a
known process such as an Ethylene Oxide or a Hydrogen Peroxide
sterilisation process.
[0016] The inclusion of one or more circumferential ribs on the
stopper can alter the force required to cause the stopper to move
from a stationary position and can also alter the sealing
properties of the stopper. To further assist in maintaining
sterility during the operations noted above the stopper may
comprise at least a front circumferential rib and a rear
circumferential rib and those ribs may be separated in a direction
along the first axis by at least 3 mm, by at least 3.5 mm, by at
least 3.75 mm or by 4 mm or more. One or more additional ribs (for
example 2, 3, 4 or 5 additional ribs, or between 1-10, 2-8, 3-6 or
4-5 additional ribs) may be arranged between the front and rear
ribs. In one embodiment there are a total of three circumferential
ribs.
[0017] A stopper with such an enhanced sterility zone can also
provide protection for the injectable medicament during a terminal
sterilisation process. Some medicaments, example a biological
medicament, could be damaged by exposure to Ethylene Oxide. More
ribs on the stopper, or a greater distance between the front and
rear ribs, can reduce the potential exposure of the medicament to
the sterilising agent.
[0018] The rod shoulder may be arranged within the external
diameter of the rod, or may be arranged outside the external
diameter of the rod. By providing a shoulder that extends beyond
the external diameter of the rod, but still fits within the body,
the shoulder can help to stabilise the movement of the rod within
the body by reducing movement of the rod perpendicular to the first
axis. The rod shoulder may comprise any suitable shoulder forming
elements on the rod, but in one embodiment the rod shoulder
comprises a substantially disc shaped portion on the rod.
[0019] In one embodiment of the syringe, when arranged with the
plunger contact surface in contact with the stopper and the
variable volume chamber is at its intended maximum volume there is
a clearance of no more than about 2 mm between the rod shoulder and
backstop shoulder. In some embodiments there is a clearance of less
than about 1.5 mm and in some less than about 1 mm. This distance
is selected to substantially limit or prevent excessive rearward
(away from the outlet end) movement of the stopper.
[0020] In one embodiment the variable volume chamber has an
internal diameter greater than 5 mm or 6 mm and less than 3 mm or 4
mm. The internal diameter may be between 3 mm and 6 mm, or between
4 mm and 5 mm. In another embodiment the syringe is dimensioned so
as to have a nominal maximum fill volume of volume of between about
0.25 ml and 0.75 ml, or between 0.4 ml and 0.6 ml. The length of
the body of the syringe may be less than 70 mm, less than 60 mm or
less than 50 mm. In one embodiment the length of the syringe body
is between 45 mm and 50 mm, the internal diameter is between 4 mm
and 5 mm and the fill volume is between 0.1 ml and 0.3 ml of
liquid.
[0021] In one embodiment, the syringe is suitable for ophthalmic
injections, and as such has a suitably small volume. The syringe
may be adapted for ophthalmic injections. The syringe may also be
silicone free, or substantially silicone free, or may comprise a
low level of silicone as lubricant. In one embodiment, the syringe
may meet USP789.
[0022] The variable volume chamber of the syringe may be filled
with any suitable injectable liquid or medication, for example an
injectable medicament. In one embodiment the variable volume
chamber is filled with an injectable medicament comprising an
active suitable for the treatment of an ocular disease. Examples of
such ocular diseases include choroidal neovascularisation,
age-related macular degeneration (both wet and dry forms), macular
edema secondary to retinal vein occlusion (RVO) including both
branch RVO (bRVO) and central RVO (cRVO), choroidal
neovascularisation secondary to pathologic myopia (PM), diabetic
macular edema (DME), diabetic retinopathy, and proliferative
retinopathy. In one embodiment, the medicament comprises a biologic
active. The biologic active may be an antibody (or fragment
thereof) or a non-antibody protein. In one embodiment the
medicament comprises a VEGF antagonist. Suitable VEGF antagonists
include ranibizumab (Lucentis.TM.), bevacizumab (Avastin.TM.),
aflibercept (Eylea.TM., also known as VEGF-Trap Eye), conbercept
(KH902 from Chengdu Kanghong Biotechnologies Co. Ltd, described as
FP3 in WO2005/121176, the contents of which are hereby incorporated
by reference) and the related glycoform KH906 or pazopanib (from
GlaxoSmithKline).
[0023] In one embodiment, the syringe is filled with between about
0.01 ml and about 2 ml (for example between about 0.05 ml and about
1 ml, between about 0.1 ml and about 0.5 ml) of an injectable
medicament. Of course, typically a syringe is filled with more than
the desired dose to be administered to the patient, to take into
account wastage due to "dead space" within the syringe and needle.
Thus, in one embodiment, the syringe is filled with a dosage volume
(i.e. the volume of medicament intended for delivery to the patent)
of between about 0.01 ml and about 2 ml (e.g. between about 0.05 ml
and about 1 ml, between about 0.1 ml and about 0.5 ml) of an
injectable medicament. For example, for Lucentis, the dosage volume
is 0.05 ml or 0.03 ml (0.5 mg or 0.3 mg) of a 10 mg/ml injectable
medicament solution; for Eylea, the dosage volume is 0.05 ml of a
40 mg/ml injectable medicament solution.
[0024] As noted above, when the syringe contains a medicament
solution the outlet may be reversibly sealed to maintain sterility
of the medicament. This sealing may be achieved through the use of
a sealing device as is known in the art. For example the OVS.TM.
system which is available from Vetter Pharma International GmbH.
The sealing of the outlet should be such that that sterility of the
contents of the variable volume chamber can be maintained until
such time as the stopper is moved to breach the sterility seal or
the outlet is unsealed. By providing a plunger that does not couple
with the stopper a new method of assembly is made possible and so
the invention further provides a method of assembling a syringe,
the method comprising the steps of: [0025] i) providing a body and
a stopper, the body comprising an outlet at an outlet end and the
stopper being arranged within the body such that a front surface of
the stopper and the body define a variable volume chamber from
which a fluid can be expelled though the outlet, the outlet being
releasably sealed and the variable volume chamber containing a
medicament; and [0026] ii) providing a plunger comprising a plunger
contact surface at a first end and a rod extending between the
plunger contact surface and a rear portion and arranging the
plunger contact surface and at least part of the plunger within the
body without coupling the plunger to the stopper.
[0027] The method may further comprise an additional step, step
iii), of filling the variable volume chamber of the syringe, which
may be filled with any suitable injectable medicament. In one
embodiment the variable volume chamber is filled with an injectable
medicament suitable for the treatment of an ocular disease.
Examples of such ocular diseases include choroidal
neovascularisation, age-related macular degeneration (both wet and
dry forms), macular edema secondary to retinal vein occlusion (RVO)
including both branch RVO (bRVO) and central RVO (cRVO), choroidal
neovascularisation secondary to pathologic myopia (PM), diabetic
macular edema (DME), diabetic retinopathy, and proliferative
retinopathy. In one embodiment, the medicament comprises a biologic
active. The biologic active may be an antibody (or fragment
thereof) or a non-antibody protein. In one embodiment the
medicament comprises a VEGF antagonist. Suitable VEGF antagonists
include ranibizumab (Lucentis.TM.), bevacizumab (Avastin.TM.),
aflibercept (Eylea.TM., also known as VEGF-Trap Eye), conbercept
(KH902 from Chengdu Kanghong Biotechnologies Co. Ltd, described as
FP3 in WO2005/121176, the contents of which are hereby incorporated
by reference) and the related glycoform KH906 or pazopanib (from
GlaxoSmithKline).
[0028] It should be noted that steps ii) and iii) above may be
carried out in either order. Thus the method may comprise, in
sequence, steps i), ii), iii) or steps i), iii), ii) or steps iii),
i), ii).
[0029] The method may further comprise a step iv) of packaging the
assembled syringe in a substantially sealed package. The method may
further comprise a terminal sterilisation step, step v), following
packaging. The terminal sterilisation step may comprise known
techniques such as Ethylene Oxide sterilisation of Hydrogen
Peroxide sterilisation.
[0030] The invention also extends to a sealed package containing a
sterile pre-filled syringe substantially as described herein.
[0031] If the rod comprises a rod shoulder as described above and
the syringe includes a removable backstop as described the backstop
may be coupled to the syringe body after the plunger has been
arranged in the body and the rod shoulder is arranged between the
outlet end and the backstop shoulder. By ensuring that the rod
shoulder is arranged between the outlet end and the backstop
shoulder when the backstop is coupled to the device a complex
mechanism for enabling the movement of the rod shoulder past the
backstop shoulder after coupling the backstop to the syringe is
avoided.
[0032] In one embodiment step i) and iii) are carried out in a
sterile, or substantially sterile, environment. At some point
between the filling step and the final assembly being sealed into
packaging the syringe is removed from the sterile, or substantially
sterile, environment. A terminal sterilisation step can then be
conducted on the packaged product.
[0033] In one embodiment of the method the plunger rod is dropped
into the syringe body. This is a simple operation and makes use of
gravity rather than any automated assembly equipment. This is made
possible because the rod does not need to be manipulated or forced
to couple with the stopper.
[0034] The invention also provides a plunger suitable for use in
the syringe or method described above.
[0035] It should be understood that throughout this specification
and in the claims that follow, unless the context requires
otherwise, the word "comprise", or variations such as "comprises"
or "comprising", implies the inclusion of the stated integer or
step, or group of integers or steps. The term "comprising"
encompasses "including" as well as "consisting" e.g. a composition
"comprising" X may consist exclusively of X or may include
something additional e.g. X+Y. It should also be understood that,
unless not physically possible, features described in connection
with one embodiment can be used alone, or in combination with one
or more features described in connection with the same embodiment
or one or more other embodiments. The term "about" in relation to a
numerical value x is optional and means, for example, x+/-10%.
[0036] The invention will now be further described, by way of
example only, with reference to the following drawings in
which:
[0037] FIG. 1 shows a side view of a syringe;
[0038] FIG. 2 shows a cross section of a top down view of a
syringe;
[0039] FIG. 3 shows a view of a plunger;
[0040] FIG. 4 shows a cross section though a plunger;
[0041] FIG. 5 shows a stopper; and
[0042] FIG. 6 shows a flowchart of the assembly process.
[0043] FIG. 1 shows a view from a side of a syringe 1 comprising a
body 2, plunger 4, backstop 6 and a sealing device 8.
[0044] FIG. 2 shows a cross section through the syringe 1 of FIG. 1
from above. The syringe 1 is suitable for use in an ophthalmic
injection. The syringe 1 comprises a body 2, a stopper 10 and a
plunger 4. The syringe 1 extends along a first axis A. The body 2
comprises an outlet 12 at an outlet end 14 and the stopper 10 is
arranged within the body 2 such that a front surface 16 of the
stopper 10 and the body 2 define a variable volume chamber 18. The
variable volume chamber 18 contains an injectable medicament 20
comprising ranibizumab. The injectable fluid 20 can be expelled
though the outlet 12 by movement of the stopper 10 towards the
outlet end 14 thereby reducing the volume of the variable volume
chamber 18. The plunger 4 comprises a plunger contact surface 22 at
a first end 24 and a rod 26 extending between the plunger contact
surface 22 and a rear portion 25. The plunger contact surface 22 is
arranged to contact the stopper 10 but not couple thereto, such
that the plunger 4 can be used to move the stopper 10 towards the
outlet end 14 of the body 2. Such movement reduces the volume of
the variable volume chamber 18 and causes fluid therein to be
expelled though the outlet. However, since the plunger 4 is not
coupled to the stopper 10 it is not possible to use the plunger 4
to move the stopper 10 away from the outlet end 14.
[0045] The backstop 6 is attached to the body 2 by coupling to a
terminal flange 28 of the body 2. The backstop 6 includes sandwich
portion 30 which is adapted to substantially sandwich at least some
of the terminal flange 28 of the body 2. The backstop 6 is adapted
to be coupled to the body 2 from the side by leaving one side of
the backstop 6 open so that the backstop 6 can be fitted to the
syringe 2.
[0046] The body 2 defines a substantially cylindrical bore 36 which
has a bore radius. The rod 26 comprises a rod shoulder 32 directed
away from the outlet end 14. The rod shoulder 32 extends to a rod
shoulder radius from the first axis A which is such that it
slightly less than the bore radius so that the shoulder fits within
the bore 36. The backstop 6 includes a backstop shoulder 34
directed towards the outlet end 14. The shoulders 32,34 are
configured to cooperate to substantially prevent movement of the
rod 26 away from the outlet end 14 when the backstop shoulder 34
and rod shoulder 32 are in contact. The backstop shoulder 34
extends from outside the bore radius to a radius less than the rod
shoulder radius so that the rod shoulder 32 cannot pass the
backstop shoulder 34 by moving along the first axis A. In this case
the rod shoulder 32 is substantially disc, or ring, shaped and the
backstop shoulder 34 includes an arc around a rear end 38 of the
body 2.
[0047] The backstop 6 also includes two finger projections 40 which
extend in opposite directions away from the body 2 substantially
perpendicular to the first axis A to facilitate manual handling of
the syringe 1 during use.
[0048] In this example the syringe comprises a 0.5 ml body 2, that
is a body with a notional maximum fill volume of about 0.5 ml,
filled with between about 0.1 and 0.3 ml of an injectable
medicament 20 comprising a 10 mg/ml injectable solution comprising
ranibizumab. The syringe body 2 has an internal diameter of about
between about 4.5 mm and 4.8 mm, a length of between about 45 mm
and 50 mm.
[0049] The plunger 4 and stopper 10 will be described in more
detail with reference to later figures.
[0050] FIG. 3 shows a perspective view of the plunger 4 of FIG. 1
showing the plunger contact surface 22 at the first end 24 of the
plunger 4. The rod 26 extends from the first end 24 to the rear
portion 25. The rear portion 25 includes a disc shaped flange 42 to
facilitate user handling of the device. The flange 42 provides a
larger surface area for contact by the user than a bare end of the
rod 26.
[0051] The rod 26 comprises ribs 44 which extend along the rod 26,
the ribs forming a cross-form cross section for the rod 26 as shown
in more detail in subsequent figures. The rod 26 comprises a disc
shaped portion 46, the disc shaped portion 46 extending radially
beyond the ribs 44 and also forming the rod shoulder 32.
[0052] The ribs 44 may be substantially solid, or may include gaps
48. The disc portion 46 may be solid, or may include gaps 50. Gaps
48,50 may be used to facilitate gas flow within the body 2 if
necessary for sterilization, or other, purposes.
[0053] FIG. 4 shows a cross section though a syringe body 2 and rod
26. The rod 26 includes four longitudinal ribs 44 and the angle
between the ribs is 90.degree..
[0054] FIG. 5 shows a detailed view of a stopper 10 showing a
conical shaped front surface 16 and three circumferential ribs
52,54,56 around a substantially cylindrical body 58. The axial gap
between the first rib 52 and the last rib 56 is about 3 mm. The
rear surface 60 of the stopper 10 includes a substantially central
recess 62. The central recess 62 includes an initial bore 64 having
a first diameter. The initial bore 64 leading from the rear surface
60 into the stopper 10 to an inner recess 66 having a second
diameter, the second diameter being larger than the first
diameter.
[0055] FIG. 6 shows a flow chart for the assembly of a syringe 1.
In Step 1 a prefilled body 2 is provided. The prefilled body
comprises a body 2 filled with an injectable medicament 20
comprising ranibizumab, although other medicaments could be used in
addition or instead, or a placebo solution could be used. A stopper
10 is arranged in the body 2 to form a variable volume chamber 18
and the outlet 12 is sealed with a sealing device 8.
[0056] In Step 2 a plunger 4 is arranged in the body 2. In one
embodiment the plunger 4 is dropped into the body 2. This may be by
gravity alone, or the plunger may be placed into the body 2 using a
machine or human and the body then oriented so that the plunger 4
falls into the body 2 until the plunger contact surface 22 makes
contact with the stopper 10.
[0057] In Step 3 a backstop 6 is coupled to the terminal flange 28
of the body. The backstop 6 and rod being arranged such that the
rod shoulder 32 is located between the outlet end of the body and
the backstop shoulder 34.
[0058] In Step 4 the syringe is sealed into a package and in Step 5
the package and its contents is sterilised in a terminal
sterilisation process. The terminal sterilisation process may use
known process such as an Ethylene Oxide or a Hydrogen Peroxide
sterilisation process.
[0059] It should be understood that the invention has been
described above by way of example only and that modifications in
detail can be made without departing from the scope of the
claims.
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