U.S. patent application number 17/569291 was filed with the patent office on 2022-04-28 for safety devce for a pre-filled syringe and an injection device.
The applicant listed for this patent is Sanofi-Aventis Deutschland GMBH. Invention is credited to Matthew Ekman, Gareth Roberts, John Slemmen.
Application Number | 20220126024 17/569291 |
Document ID | / |
Family ID | |
Filed Date | 2022-04-28 |
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United States Patent
Application |
20220126024 |
Kind Code |
A1 |
Roberts; Gareth ; et
al. |
April 28, 2022 |
SAFETY DEVCE FOR A PRE-FILLED SYRINGE AND AN INJECTION DEVICE
Abstract
According to the invention, a safety device for a pre-filled
syringe with an injection needle comprises of a support body
adapted to mount the pre-filled syringe, a needle shield slidably
arranged with respect to the support body, a retention and locking
means (M) for retaining and locking the needle shield with respect
to the support body in a first and a second advanced position (PA1,
PA2) and in a retracted position (PR). The needle shield comprises
an annular flange adapted to rest on the skin of the patient
receiving an injection. The retention and locking means (M) are
arranged at a distal end of the safety device.
Inventors: |
Roberts; Gareth; (Wrexham,
GB) ; Slemmen; John; (Mereyside, GB) ; Ekman;
Matthew; (Cheshire, GB) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Sanofi-Aventis Deutschland GMBH |
Frankfurt am Main |
|
DE |
|
|
Appl. No.: |
17/569291 |
Filed: |
January 5, 2022 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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16139823 |
Sep 24, 2018 |
11246993 |
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17569291 |
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15165624 |
May 26, 2016 |
10080847 |
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16139823 |
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13997370 |
Jun 24, 2013 |
9352101 |
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PCT/EP2011/074277 |
Dec 30, 2011 |
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15165624 |
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International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 4, 2011 |
EP |
11150080.7 |
Claims
1. A safety device (1) for a pre-filled syringe (2) with an
injection needle (2.1) comprising a support body (1.2) adapted to
mount the pre-filled syringe (2), a needle shield (1.1) slidably
arranged with respect to the support body (1.2), a retention and
locking means (M) for retaining and locking the needle shield (1.1)
with respect to the support body (1.2) in a first and a second
advanced position (PA1, PA2) and in a retracted position (PR),
wherein the needle shield (1.1) comprises an annular flange (1.1.1)
adapted to rest on the skin of the patient receiving an injection
and wherein the retention and locking means (M) are arranged at a
distal end of the safety device (1).
2. A safety device (1) according to claim 1, characterized in that
the support body (1.2), the needle shield (1.1) and/or the outer
body (1.3) is at least partially made from a transparent plastics
material.
3. A safety device (1) according to claim 1 or 2, characterized in
that the needle shield (1.1) is movable from the first advanced
position (PA1) to the retracted position (PR) and further to the
second advanced position (PA2), wherein the needle shield (1.1) in
the first advanced position (PA1) protrudes the support body (1.2)
in the distal direction by a first distance (D1) and the needle
shield (1.1) in the second advanced position (PA2) protrudes the
support body (1.2) in the distal direction by a second distance
(D2), wherein the first distance (D1) is smaller than the second
distance (D2).
4. A safety device (1) according to one of the previous claims,
characterized in that the retaining and locking means (M) are
arranged to releasably retain the needle shield (1.1) in the first
advanced position (PA1) in a manner that is releasable by a linear
translatory movement of the needle shield (1.1) with respect to the
support body (1.2) parallel to a central axis (A) of the safety
device (1).
5. A safety device (1) according to one of the previous claims,
characterized in that the retention and locking means (M) comprise
at least one deflectable resilient arm (1.1.2).
6. A safety device (1) according to one of the previous claims,
characterized in that the resilient arm (1.1.2) is arranged with
the needle shield (1.1) as one piece and is arranged within the
needle shield (1.1.1) so as to shield the resilient arms (1.1.2)
from being influenced from the exterior.
7. A safety device (1) according to one of the previous claims,
characterized in that the resilient arm (1.1.2) latches to a
catching recess (1.2.3) formed to a distal end of the support body
(1.2) to releasably retain the needle shield (1.1) in the first
advanced position (PA1).
8. A safety device (1) according to one of the previous claims,
characterized in that resilient arm (1.1.2) is pre-tensioned and
deflected in the radial outward direction when latching to the
catching recess (1.2.3) to releasably retain the needle shield
(1.1) in the first advanced position (PA1).
9. A safety device (1) according to claim 8, characterized in that
the pre-tensioned resilient arm (1.1.2) unbends due to a material
memory effect when the needle shield (1.1) is released from being
retained in the first advanced position (PA1).
10. A safety device (1) according to claim 7, characterized in that
the resilient arm (1.1.2) is stressed and inwardly deflected when
the needle shield (1.1) is in the retracted and in the second
advanced position (PA2).
11. A safety device (1) according to claim 10, characterized in
that at least two of the stressed and inwardly deflected resilient
arms (1.1.2) are locked to each other by interlocking elements
(1.1.4) of the retaining and locking means (M).
12. A safety device (1) according to claim 11, characterized in
that two inwardly deflected resilient arms (1.1.2) that are
arranged opposite to each other are locked to each other by two
interjacent interlocking elements (1.1.4) arranged opposite to each
other in manner that the two inwardly deflected resilient arms
(1.1.2) and the two interlocking elements (1.1.4) form an
interlocked structure (S) that comprises an essentially ring-shaped
cross-section.
13. A safety device (1) according to one of the previous claims,
characterized in that the needle shield (1.1) is biased with
respect to the support body (1.2) in the distal direction by a
spring means (1.4).
14. A safety device (1) according to one of the previous claims,
characterized in that the spring means (1.4) comprises a spring arm
(1.4.1) made from a plastics material, wherein the spring arm
(1.4.1) is attached to the needle shield (1.1) and engages a first
ramp (1.2.6) formed to an outer surface of the support body
(1.2).
15. An injection device (D) comprising a safety device (1)
according to one of the previous claims and a pre-filled syringe
(2), wherein the safety device (1) comprises a support body (1.2)
adapted to mount the pre-filled syringe (2), a needle shield (1.1)
slidably arranged with respect to the support body (1.2), a
retention and locking means (M) for retaining and locking the
needle shield (1.1) with respect to the support body (1.2) in a
first and a second advanced position (PA1, PA2) and in a retracted
position (PR), wherein the retention and locking means (M) are
arranged at a distal end of the safety device (1).
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] The present application is a continuation of U.S. Ser. No.
16/139,823, filed Sep. 24, 2018, which is a continuation of U.S.
Ser. No. 15/165,624, filed May 26, 2016, which is a continuation of
Ser. No. 13/997,370, filed Jun. 24, 2013, which is a National Phase
application pursuant to 35 U.S.C. .sctn. 371 of International
Application No. PCT/EP2011/074277, filed Dec. 30, 2011, which
claims priority to European Patent Application No. 11150080.7,
filed Jan. 4, 2011. The entire disclosure contents of these
applications are herewith incorporated by reference into the
present application.
TECHNICAL FIELD
[0002] The present invention relates to safety devices that provide
needle safety and more particularly to safety devices for
pre-filled syringes. The safety device is adapted to avoid
accidental needle pricks and needle injuries before, during and
after an injection of a medicament or drug contained in the
pre-filled syringe. In particular, the safety device provides
needle safety for a subcutaneous self-administrated injection or
for an injection administered by a health-care professional. The
present invention further relates to injection devices comprising
pre-filled syringes.
BACKGROUND
[0003] Pre-filled syringes that are filled with a selected dosage
of a medicament are well known injection devices for administering
the medicament to a patient. Safety devices for covering a needle
of a pre-filled syringe before and after use are also well known.
Typically, these devices comprise a needle shield that is either
manually moved or moved by the action of a relaxing spring to
surround the needle.
[0004] A different type of safety devices known in the state of the
art solves the object of providing needle safety by arranging the
pre-filled syringe movable relative to a body, whereas the
pre-filled syringe is retracted into the body after the
injection.
SUMMARY
[0005] Certain aspects of the present invention can provide an
improved safety device for a pre-filled syringe.
[0006] Certain aspects of the invention can provide an improved
injection device comprising a pre-filled syringe that is safe to
handle and in particular prevents accidental needle stick
injuries.
[0007] The aspects can be implemented by a safety device according
to the pending claims.
[0008] Preferred embodiments of the invention are given in the
dependent claims.
[0009] In the context of this specification, the terms distal and
proximal are defined from the point of view of a person performing
an injection. Consequently, a distal direction refers to a
direction pointing towards the body of a patient receiving an
injection and a distal end defines an end of an element that is
directed towards the body of the patient. Respectively, the
proximal end of an element or the proximal direction is directed
away from the body of the patient receiving the injection and
opposite to the distal end or distal direction.
[0010] According to the invention, a safety device for a pre-filled
syringe with an injection needle comprises [0011] a support body
adapted to mount the pre-filled syringe, [0012] a needle shield
slidably arranged with respect to the support body, [0013] a
retention and locking means for retaining and locking the needle
shield with respect to the support body in a first and a second
advanced position and in a retracted position.
[0014] The needle shield comprises an annular flange adapted to
rest on the skin of the patient receiving an injection. The
retention and locking means are arranged at a distal end of the
safety device.
[0015] The needle shield and the support body are arranged so as to
telescope with respect to each other between three different
positions, namely the first and second advanced position and the
retracted position, so as to cover and to expose the injection
needle of the pre-filled syringe that may be mounted within the
support body of the safety device. Needle safety is provided in at
least the second position, so that accidental needle stick injuries
may be prevented. In the retracted position, the injection needle
is exposed so as to allow tor an insertion of the injection needle
into the skin of the patient receiving the injection.
[0016] The safety mechanism of the safety device can be viewed as
an advancing mechanism that advances the needle shield to the
second advanced position after the injection is completed.
Alternatively, the safety mechanism may be equivalently described
as a retraction mechanism that retracts the injection needle
connected to the support body into the needle shield after the
injection is completed. The difference between the retraction and
the advancing mechanism originates from size of the needle shield
relative to the size of the support body. The larger part may be
deemed as being static during the telescoping movement of the
needle shield and the support body. Thus, a safety device within
the scope of the present invention with a relative large support
body may be viewed as comprising an advancing mechanism, whereas a
safety device within the scope of the present invention with a
relative large needle shield may be seen as comprising an
retraction mechanism.
[0017] The needle shield comprises an annular flange of increased
surface that is adapted to rest on the skin of the patient
receiving the injection. The needle shield is axially translated
between the first advanced position and the retracted position by
pushing the safety device against the skin of the patient, whereby
the injection needle is inserted into the skin. The safety device
is particularly intuitive to operate. Furthermore, the needle
shield may be made from an opaque material, so that the injection
needle is hidden from the view of the patient. This may help to
reduce a possible patient's fear of needles and/or injections.
[0018] The arrangement of the retention and locking means at the
distal end of the safety device allows for a particularly compact
design of the safety device. In particular, the length of the
needle shield providing needle safety for the injection needle of
the pre-filled syringe retained within and attached to the support
body may be minimized. This saves material costs in the
manufacturing process of the safety device. The safety device may
thus be economically mass-produced. Therefore, the safety device is
well suited as a disposable device that is only used in a single
injection.
[0019] Preferably, the support body, the needle shield and/or the
outer body is at least partially made from a transparent plastics
material. The support body, the needle shield and/or the outer body
may either be completely made from a transparent material or,
alternatively, comprise windows or sections that are made from a
transparent material. Benefits for having multiple transparent
components within the design include aiding visual clarity of
contents, reducing the size of the overall visual appearance and
adding accuracy to the needle insertion. The retention and locking
means are arranged at the distal end of the safety device, so that
a view of a user is not obstructed. The content of the pre-filled
syringe retained within the support body may be visible at all
times. A dose of a medicament or drug is contained in an inner
cavity of the pre-filled syringe. The user may visually check the
content of the pre-filled syringe throughout the injection.
[0020] The needle shield is movable from the first advanced
position to the retracted position and further to the second
advanced position. The needle shield in the first advanced position
protrudes the support body in the distal direction by a first
distance. Furthermore, the needle shield in the second advanced
position protrudes the support body in the distal direction by a
second distance and surrounds the injection needle of the
pre-filled syringe after the injection. The first distance is
smaller than the second distance to indicate that the safety device
has been used.
[0021] The retaining and locking means are arranged to releasably
retain the needle shield in the first advanced position in a manner
that is releasable by a linear translatory movement of the needle
shield with respect to the support body parallel to a central axis
of the substantially cylindrical safety device. The needle shield
is simply pressed against the skin of a patient, whereby the needle
shield slides distally and parallel to the central axis towards a
retracted position. The distal movement releases the retention of
the needle shield in the first advanced position and thus activates
the safety mechanism of the safety device that prevents accidental
needle stick injuries after the injection.
[0022] Preferably, the retention and locking means comprise at
least one deflectable resilient arm that provides a simple means
for retaining the needle shield in the first advanced position.
[0023] According to a possible embodiment of the invention, the
resilient arm is arranged with the needle shield as one piece. In
particular, the resilient arm may be integrally moulded to the
needle shield. The safety device comprises only a few parts
preferably made from a plastics material and is inexpensive to
manufacture. The resilient arm is arranged within the needle shield
so as to prevent the resilient arm and thus the retention of the
needle shield in the first, the second and or the retracted
position from being influenced from the exterior. This ensures that
the safety device works reliably and in particular hinders a person
from tampering with the resilient arm locking the needle shield in
the second advanced position. Therefore, the safety device is
permanently prevented from being re-used after the injection has
been carried out.
[0024] The needle shield is preferably arranged as a double-walled
shield, wherein the resilient arm is integrated to the inner wall
to prevent the person from tampering with the resilient arm.
[0025] The resilient arm latches to a catching recess formed into a
distal end of the support body to releasably retain the needle
shield in the first advanced position.
[0026] According to another possible embodiment of the invention,
the resilient arm is pre-tensioned and deflected in the radial
outward direction when latching to the catching recess to
releasably retain the needle shield in the first advanced position.
The resilient arm is initially stressed and relaxes as soon as the
needle shield is pushed with respect to the support body in the
distal direction to release the needle shield.
[0027] The pre-tensioned resilient arm unbends due to a material
memory effect when the needle shield is released from being
retained in the first advanced position. In the unstressed state,
the resilient arm essentially extends parallel to the central axis
of safety device, so that the resilient arm is prevented from
engaging the catching recess for a second time. Upon release of the
needle shield, the safety mechanism of the safety device is
activated. The injection needle is automatically shielded after the
injection, whereby a re-use of the safety device and/or the
injection device is prevented. Thus, infections resulting from
needle stick injuries with contaminated injection needles may be
avoided.
[0028] According to yet another embodiment, the resilient arm is
stressed and inwardly deflected when the needle shield is in the
retracted and in the second advanced position. In this embodiment,
the resilient arm is initially in an unstressed state and is
energized during use of the safety device in an injection. This
avoids a malfunctioning of the safety device due to material
fatigue after prolonged periods of storage of the safety
device.
[0029] In particular, the retention and locking means of the safety
device may comprise a plurality of resilient arms that reliably
retain the needle shield in various positions. According to a
possible embodiment of the invention, two of the stressed and
inwardly deflected resilient arms are locked to each other by
interlocking elements of the retaining and locking means arranged
within the needle shield. The safety mechanism of the safety device
has a compact design and may further be miniaturized to be used in
connection with needle tip safety device that are attached to a hub
mounting an injection needle or to a distal tip of a pre-filled
syringe.
[0030] In another embodiment, the resilient arms are made from a
metal material to overcome problems with material fatigue.
Furthermore, resilient arms made from the metal material may
advantageously be miniaturized to smaller length scales allowing
for a compact design of the safety device without compromising
reliability.
[0031] Two inwardly deflected resilient arms that are arranged
opposite to each other may be locked to each other by two
interjacent interlocking elements arranged opposite to each other.
The two inwardly deflected resilient arms and the two interlocking
elements form an interlocked structure that comprises an
essentially ring-shaped cross-section. The ring-shaped interlocked
structure comprises a reduced diameter that ensures that the
released needle shield may move with respect to the support body
without getting stuck or jammed. Furthermore, the compact design of
this embodiment of the invention allows for a reduction of material
and production costs.
[0032] The needle shield is biased with respect to the support body
in the distal direction by a spring means. The spring means
provides an energy source to move the needle shield to the second
advanced position. A separate interaction is not required from the
user to provide needle safety after the injection has been carried
out.
[0033] According to yet another embodiment of the invention, the
spring means comprises at least one spring arm made from a plastics
material. The spring arm provides an alternative spring means that
is particularly inexpensive mass-produced. The flexible spring arm
is attached to the needle shield and engages a first ramp formed to
an outer surface of the support body, whereby the spring arm is
deflected and stressed. The deflected and stressed spring arm
biases the needle shield in the distal direction. As the spring arm
is stored in a unstressed state and is energized during the
injection, malfunctions resulting from material fatigue is
avoided.
[0034] According to the invention, an injection device comprises a
safety device and a pre-filled syringe. The safety device comprises
[0035] a support body adapted to mount the pre-filled syringe,
[0036] a needle shield slidably arranged with respect to the
support body, [0037] a retention and locking means for retaining
and locking the needle shield with respect to the support body in a
first and a second advanced position and in a retracted
position.
[0038] The retention and locking means are arranged at a distal end
of the safety device. The injection device comprising the
pre-filled syringe and the safety device combines the
aforementioned advantages and avoids inadvertent needle sticks
injuries. The injection device is cheap to manufacture and is
disposed after a single injection has been carried out.
[0039] The injection device is well suited to be used for
self-administered injections and for injections performed by a
health care professional. Consequently, the person referred to as
the patient or the user may be one and the same person.
[0040] The pre-filled syringe may be filled with a medicament.
[0041] The term "medication", or "drug", or "medicament", as used
herein, means a pharmaceutical formulation containing at least one
pharmaceutically active compound,
[0042] wherein in one embodiment the pharmaceutically active
compound has a molecular weight up to 1500 Da and/or is a peptide,
a protein, a polysaccharide, a vaccine, a DNA, a RNA, an enzyme, an
antibody or a fragment thereof, a hormone or an oligonucleotide, or
a mixture of the above-mentioned pharmaceutically active
compound,
[0043] wherein in a further embodiment the pharmaceutically active
compound is useful for the treatment and/or prophylaxis of diabetes
mellitus or complications associated with diabetes mellitus such as
diabetic retinopathy, thromboembolism disorders such as deep vein
or pulmonary thromboembolism, acute coronary syndrome (ACS),
angina, myocardial infarction, cancer, macular degeneration,
inflammation, hay fever, atherosclerosis and/or rheumatoid
arthritis,
[0044] wherein in a further embodiment the pharmaceutically active
compound comprises at least one peptide for the treatment and/or
prophylaxis of diabetes mellitus or complications associated with
diabetes mellitus such as diabetic retinopathy,
[0045] wherein in a further embodiment the pharmaceutically active
compound comprises at least one human insulin or a human insulin
analogue or derivative, glucagon-like peptide (GLP-1) or an
analogue or derivative thereof, or exendin-3 or exendin-4 or an
analogue or derivative of exendin-3 or exendin-4.
[0046] Insulin analogues are for example Gly(A21), Arg(B31),
Arg(B32) human insulin; Lys(B3), Glu(B29) human insulin; Lys(B28),
Pro(B29) human insulin; Asp(B28) human insulin; human insulin,
wherein proline in position B28 is replaced by Asp, Lys, Leu, Val
or Ala and wherein in position B29 Lys may be replaced by Pro;
Ala(B26) human insulin; Des(B28-B30) human insulin; Des(B27) human
insulin and Des(B30) human insulin.
[0047] Insulin derivates are for example B29-N-myristoyl-des(B30)
human insulin; B29-N-palmitoyl-des(B30) human insulin;
B29-N-myristoyl human insulin; B29-N-palmitoyl human insulin;
B28-N-myristoyl LysB28ProB29 human insulin;
B28-N-palmitoyl-LysB28ProB29 human insulin;
B30-N-myristoyl-ThrB29LysB30 human insulin;
B30-N-palmitoyl-ThrB29LysB30 human insulin;
B29-N--(N-palmitoyl-Y-glutamyl)-des(B30) human insulin;
B29-N--(N-lithocholyl-Y-glutamyl)-des(B30) human insulin;
B29-N-(.omega.-carboxyheptadecanoyl)-des(B30) human insulin and
B29-N-(.omega.-carboxyhepta decanoyl) human insulin.
[0048] Exendin-4 for example means Exendin-4(1-39), a peptide of
the sequence H
His-Gly-Glu-Gly-Thr-Phe-Thr-Ser-Asp-Leu-Ser-Lys-Gln-Met-Glu-Glu-Glu-Ala-V-
al-Arg-Leu-Phe-Ile-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-
-Pro-Ser-NH2.
[0049] Exendin-4 derivatives are for example selected from the
following list of compounds:
H-(Lys)4-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pro36, des Pro37 Exendin-4(1-39)-NH2,
des Pro36 Exendin-4(1-39),
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39); or
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, IsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, IsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(O2)25, IsoAsp28] Exendin-4(1-39),
[0050] wherein the group -Lys6-NH2 may be bound to the C-terminus
of the Exendin-4 derivative; or an Exendin-4 derivative of the
sequence
des Pro36 Exendin-4(1-39)-Lys6-NH2 (AVE0010),
H-(Lys)6-des Pro36 [Asp28] Exendin-4(1-39)-Lys6-NH2,
des Asp28 Pro36, Pro37, Pro38Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro38 [Asp28] Exendin-4(1-39)-NH2,
H-Asn-(Glu)5des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Trp(O2)25]
Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36 [Met(O)14, Asp28] Exendin-4(1-39)-Lys6-NH2,
des Met(O)14 Asp28 Pro36, Pro37, Pro38 Exendin-4(1-39)-NH2,
H-(Lys)6-desPro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5 des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-Lys6-des Pro36 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-Lys6-NH2,
H-des Asp28 Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25]
Exendin-4(1-39)-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Asp28]
Exendin-4(1-39)-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-NH2,
des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(S1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pro36, Pro37, Pro38 [Met(O)14, Trp(O2)25, Asp28]
Exendin-4(1-39)-(Lys)6-NH2;
[0051] or a pharmaceutically acceptable salt or solvate of any one
of the afore-mentioned Exendin-4 derivative.
[0052] Hormones are for example hypophysis hormones or hypothalamus
hormones or regulatory active peptides and their antagonists as
listed in Rote Liste, ed. 2008, Chapter 50, such as Gonadotropine
(Follitropin, Lutropin, Choriongonadotropin, Menotropin),
Somatropine (Somatropin), Desmopressin, Terlipressin, Gonadorelin,
Triptorelin, Leuprorelin, Buserelin, Nafarelin, Goserelin.
[0053] A polysaccharide is for example a glucosaminoglycane, a
hyaluronic acid, a heparin, a low molecular weight heparin or an
ultra low molecular weight heparin or a derivative thereof, or a
sulphated, e.g. a poly-sulphated form of the above-mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof.
An example of a pharmaceutically acceptable salt of a
poly-sulphated low molecular weight heparin is enoxaparin
sodium.
[0054] Antibodies are globular plasma proteins (.about.150 kDa)
that are also known as immunoglobulins which share a basic
structure. As they have sugar chains added to amino acid residues,
they are glycoproteins. The basic functional unit of each antibody
is an immunoglobulin (Ig) monomer (containing only one Ig unit);
secreted antibodies can also be dimeric with two Ig units as with
IgA, tetrameric with four Ig units like teleost fish IgM, or
pentameric with five Ig units, like mammalian IgM.
[0055] The Ig monomer is a "Y"-shaped molecule that consists of
four polypeptide chains; two identical heavy chains and two
identical light chains connected by disulfide bonds between
cysteine residues. Each heavy chain is about 440 amino acids long;
each light chain is about 220 amino acids long. Heavy and light
chains each contain intrachain disulfide bonds which stabilize
their folding. Each chain is composed of structural domains called
Ig domains. These domains contain about 70-110 amino acids and are
classified into different categories (for example, variable or V,
and constant or C) according to their size and function. They have
a characteristic immunoglobulin fold in which two f3 sheets create
a "sandwich" shape, held together by interactions between conserved
cysteines and other charged amino acids.
[0056] There are five types of mammalian Ig heavy chain denoted by
.alpha., .delta., .epsilon., .gamma., and .mu.. The type of heavy
chain present defines the isotype of antibody; these chains are
found in IgA, IgD, IgE, IgG, and IgM antibodies, respectively.
[0057] Distinct heavy chains differ in size and composition;
.alpha. and .gamma. contain approximately 450 amino acids and
.delta. approximately 500 amino acids, while .mu. and .epsilon.
have approximately 550 amino acids. Each heavy chain has two
regions, the constant region (CH) and the variable region (VH). In
one species, the constant region is essentially identical in all
antibodies of the same isotype, but differs in antibodies of
different isotypes. Heavy chains .gamma., .alpha. and .delta. have
a constant region composed of three tandem Ig domains, and a hinge
region for added flexibility; heavy chains .mu. and .epsilon. have
a constant region composed of four immunoglobulin domains. The
variable region of the heavy chain differs in antibodies produced
by different B cells, but is the same for all antibodies produced
by a single B cell or B cell clone. The variable region of each
heavy chain is approximately 110 amino acids long and is composed
of a single Ig domain.
[0058] In mammals, there are two types of immunoglobulin light
chain denoted by .lamda. and .kappa.. A light chain has two
successive domains: one constant domain (CL) and one variable
domain (VL). The approximate length of a light chain is 211 to 217
amino acids. Each antibody contains two light chains that are
always identical; only one type of light chain, .kappa. or .lamda.,
is present per antibody in mammals.
[0059] Although the general structure of all antibodies is very
similar, the unique property of a given antibody is determined by
the variable (V) regions, as detailed above. More specifically,
variable loops, three each the light (VL) and three on the heavy
(VH) chain, are responsible for binding to the antigen, i.e. for
its antigen specificity. These loops are referred to as the
Complementarity Determining Regions (CDRs). Because CDRs from both
VH and VL domains contribute to the antigen-binding site, it is the
combination of the heavy and the light chains, and not either
alone, that determines the final antigen specificity.
[0060] An "antibody fragment" contains at least one antigen binding
fragment as defined above, and exhibits essentially the same
function and specificity as the complete antibody of which the
fragment is derived from. Limited proteolytic digestion with papain
cleaves the Ig prototype into three fragments. Two identical amino
terminal fragments, each containing one entire L chain and about
half an H chain, are the antigen binding fragments (Fab). The third
fragment, similar in size but containing the carboxyl terminal half
of both heavy chains with their interchain disulfide bond, is the
crystalizable fragment (Fc). The Fc contains carbohydrates,
complement-binding, and FcR-binding sites. Limited pepsin digestion
yields a single F(ab')2 fragment containing both Fab pieces and the
hinge region, including the H--H interchain disulfide bond. F(ab')2
is divalent for antigen binding. The disulfide bond of F(ab')2 may
be cleaved in order to obtain Fab'. Moreover, the variable regions
of the heavy and light chains can be fused together to form a
single chain variable fragment (scFv).
[0061] Pharmaceutically acceptable salts are for example acid
addition salts and basic salts. Acid addition salts are e.g. HCl or
HBr salts. Basic salts are e.g. salts having a cation selected from
alkali or alkaline, e.g. Na+, or K+, or Ca2+, or an ammonium ion
N+(R1)(R2)(R3)(R4), wherein R1 to R4 independently of each other
mean: hydrogen, an optionally substituted C1 C6-alkyl group, an
optionally substituted C2-C.sub.6-alkenyl group, an optionally
substituted C6-C10-aryl group, or an optionally substituted
C6-C10-heteroaryl group. Further examples of pharmaceutically
acceptable salts are described in "Remington's Pharmaceutical
Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark Publishing
Company, Easton, Pa., U.S.A., 1985 and in Encyclopedia of
Pharmaceutical Technology.
[0062] Pharmaceutically acceptable solvates are for example
hydrates.
[0063] Further scope of applicability of the present invention will
become apparent from the detailed description given hereinafter.
However, it should be understood that the detailed description and
specific examples, while indicating preferred embodiments of the
invention, are given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description.
BRIEF DESCRIPTION OF THE DRAWINGS
[0064] The present invention will be better understood from the
detailed description given in the following. The accompanying
drawings are given for illustrative purposes only and do not limit
the scope of the present invention.
[0065] FIG. 1 shows a perspective view of an injection device D
according to a first embodiment of the invention before use;
[0066] FIG. 2 shows a sectional view of the injection device D
according to the first embodiment before use;
[0067] FIG. 3 shows a sectional view of the injection device D
according to the first embodiment before a medicament is
administered to a patient;
[0068] FIG. 4 shows a sectional view of the injection device D
according to the first embodiment with a needle shield retracted in
a retracted position;
[0069] FIG. 5 shows a sectional view of the injection device D
according to the first embodiment after a medicament has been
administered to the patient;
[0070] FIGS. 6A and 6B show two different sectional views of the
injection device D according to the first embodiment after removal
from the injection site;
[0071] FIG. 7 shows a sectional view of the injection device D
according to a second embodiment before use;
[0072] FIG. 8A to 8E illustrate in detail the retention and locking
means arranged at the distal end of the safety device 1 according
to the first and second embodiment of the invention;
[0073] FIG. 9 shows a perspective view of an injection device D
according to a third embodiment of the invention before use;
[0074] FIG. 10 shows a sectional view of the injection device D
according to the third embodiment before use;
[0075] FIGS. 11A and 11B show two cross-sections of the needle
shield 1.1 according to third embodiment of the invention;
[0076] FIG. 12 shows a sectional view of the injection device D
according to the third embodiment before the medicament is
administered to a patient;
[0077] FIG. 13 shows the injection device D according to the third
embodiment after a medicament has been administered to the
patient;
[0078] FIG. 14 shows the injection device D according to the third
embodiment in a needle safe state;
[0079] FIG. 15 shows a sectional view of an injection device D
according to a forth embodiment of the invention with the needle
shield retained in the retracted position;
[0080] FIGS. 16A to 16D illustrate in detail the retention and
locking means according to the third and forth embodiment of the
invention;
[0081] FIGS. 17A to 17D schematically illustrate possible
arrangements of a resilient arm retaining the needle shield
relative to the support body.
[0082] Corresponding parts are marked with the same reference
symbols in all figures.
DETAILED DESCRIPTION
[0083] FIG. 1 shows a perspective view of an injection device D
with a safety device 1 for a pre-filled syringe 2 according to a
first embodiment of the invention. The safety device 1 comprises a
substantially cylindrical and hollow needle shield 1.1 with an
annular flange 1.1.1 arranged at a distal end thereof. The needle
shield 1.1 is arranged as a double walled shield with a
substantially inner and outer wall. The annular flange 1.1.1
projects radial outwards from the needle shield 1.1. and is adapted
to rest on the skin of the patient during the injection. Edges of
the annular flange 1.1.1 are rounded for comfort and to avoid
injuries. The needle shield 1.1 is slidably arranged with respect
to a support body 1.2 that receives and mounts the pre-filled
syringe 2.
[0084] Before usage of the safety device 1, the needle shield 1.1
is initially retained in a first advanced position PA1. The needle
shield 1.1 in the first advanced position PA1 protrudes the support
body 1.2 in a distal direction by a first distance D1.
[0085] An annular bearing surface 1.2.1 is formed to the support
body 1.2 that protrudes radial outwards. The annular bearing
surface 1.2.1 limits the sliding movement of the needle shield 1.1
with respect to the support body 1.2 in the proximal direction.
[0086] The safety device 1 comprises an essentially cylindrical and
hollow outer body 1.3 with an open distal and a closed proximal
end. The proximal end of the support body 1.2 is received within
the open distal end of the outer body 1.3. The outer body 1.3 is
slidably arranged with respect to the support body 1.2 and may
slide in a distal direction to substantially receive the support
body 1.2 at the end of an injection stroke.
[0087] A circumferential and outwardly protruding support flange
1.3.1 is integrally formed to an outer surface of the outer body
1.3 close to its distal end. The outer body 1.3 is adapted to be
gripped and pushed by a user in the distal direction, whereby the
support flange 1.3.1 supports the hand of the user performing the
injection stroke.
[0088] Preferably, the needle shield 1.1, the support body 1.2 and
the outer body 1.3 are made from a plastics material. The needle
shield 1.1 may be made from an opaque plastics material to hide an
injection needle 2.1 of the pre-filled syringe 2 from the view of a
patient throughout the injection. This may help to ease a possible
fear of needles of the patient. Alternatively, the needle shield
1.1 may be made from a transparent plastics material, so that the
user may visually confirm the correct placement of the injection
needle 2.1 and easily insert the injection needle 2.1 into the skin
of the patient.
[0089] According to a possible embodiment of the invention, the
support body 1.2 is made from a transparent material, so that the
content of the pre-filled syringe 2 received within the support
body 1.2 is visible. The safety device 1 comprises retention and
locking means M arranged at the distal end of the safety device 1.
Thus, the retention and locking means do not obstruct the view of
the user checking the content of the pre-filled syringe 2.
[0090] FIG. 2 shows a sectional view of the injection device D
before use. The injection needle 2.1 of the pre-filled syringe 2 is
covered by a needle cap 2.2 that engages a distal tip of a barrel
2.3. Preferably, the needle cap 2.2 is at least partially made from
a plastics material like rubber.
[0091] The pre-filled syringe 2 inserted into the support body 1.3
and attached thereto by a mechanical connection engages a proximal
barrel collar 2.3.1 of the barrel 2.3.
[0092] An inner cavity 2.3.2 of the pre-filled syringe 2 contains a
dose of a medicament or drug. A stopper 2.4 that is connected to a
plunger 2.5 fluid-tightly seals a proximal end of the inner cavity
2.3.2. The stopper 2.4 may be moved by pushing the plunger 2.5 in
the distal direction to expel the dose of the medicament through
the injection needle 2.1. The plunger 2.5 is attached to or abuts
an inner surface of the outer body 1.3, so that the plunger 2.5 and
the stopper 2.4 connected thereto may be moved by pushing the outer
body 1.3 with respect to the support body 1.2 in the distal
direction.
[0093] A spring means 1.4 is arranged within the needle shield 1.1
and biases the needle shield 1.1 with respect to the support body
1.2 in the distal direction. According to the first embodiment of
the invention, the spring means 1.4 is designed as a compression
spring made from a metal. Alternatively, the spring means 1.4 may
comprise other suitable means to bias the needle shield 1.1, like,
for example, a torsion spring or resiliently deflectable spring
arms made from suitable plastics materials.
[0094] The retention and locking means M that releasable retain the
needle shield 1.1 in the first advanced position PA1 are arranged
at the distal end of the safety device 1. The retention and locking
means M comprise a catch 1.2.2 formed to an outer surface of the
support body 1.2 and protruding therefrom in a radial outward
direction to engage the needle shield 1.1.
[0095] FIG. 3 shows a sectional view of the injection device D
after removal of the needle cap 2.2. The retention and locking
means M comprise two resilient arms 1.1.2 integrally moulded to the
needle shield 1.1 and arranged opposite to each other. The
resilient arm 1.1.2 is arranged within the needle shield 1.1 to
shield the resilient arm 1.1.2 from exterior influences. In
particular, the arrangement of the resilient arm 1.1.2 prevents a
person from tampering with the resilient arm 1.1.2 retaining and
locking the needle shield 1.1 in various positions. With
cross-reference to FIG. 8A, it can be seen that the resilient arms
1.1.2 are radial outwardly deflected and in the pre-tensioned
state. The resilient arms 1.1.2 latch to a catching recess 1.2.3
formed into the distal end of the support body 1.2 to releasably
retain the needle shield 1.1 in the first advanced position PAL The
mechanical connection between the outwardly flexing resilient arm
1.1.2 and the catching recess 1.2.3 may be released by a linear
translatory of movement of the needle shield 1.1 with respect to
the support body 1.2 parallel to a central axis A of the
substantially cylindrical safety device 1, whereby the deflected
resilient arm 1.1.2 unbends due to a material memory effect.
[0096] FIG. 4 shows a sectional view of the injection device D
before an injection stroke is performed by the user. The needle
shield 1.1 is located in a retracted position PR and bears against
the annular bearing surface 1.2.1 in the proximal direction. The
injection needle 2.1 of the pre-filled syringe 2 protrudes the
annular flange 1.1.1 of the needle shield 1.1 in the distal
direction. The spring means 1.4 designed as the compression spring
is fully compressed and stressed.
[0097] An outward projection 1.2.4 is formed to a proximal end of
the support body 1.2 that protrudes radial outwards into a
longitudinal recess 1.3.2 formed into an inner surface of the outer
body 1.3. Preferably, two outward projections 1.2.4 are formed to
opposite sides of the support body 1.2 that are received within
respective longitudinal recesses 1.3.2 of the outer body. The
longitudinal recess 1.3.2 extends parallel to the central axis A
and over a substantial axial length of the outer body 1.3. The
outward projection 1.2.4 travels within the longitudinal recess
1.3.2 when the outer body 1.3 is slid with respect to the support
body 1.2 to expel the dose of the medicament contained in the
pre-filled syringe 2 through the injection needle 2.1. This avoids
a relative rotation between the outer body 1.3 and the support body
1.2 during the injection, so that a jamming of these parts 1.2, 1.3
may be prevented.
[0098] Furthermore, a first inward projection 1.3.3 is located at
the distal end of the longitudinal recess 1.3.2 that abuts the
outward projection 1.2.4 of the support body 1.2. The outward
projection 1.2.4 has to overcome the first inward projection 1.3.3
before the outer body 1.3 may travel with respect to the support
body 1.2 in the distal direction. The interaction between the
inward and outward projection 1.3.3, 1.2.4 generates a resistive
force that is larger than a respective required force required to
move the needle shield 1.1 from the first advanced position PA1 to
the retracted position PR. This ensures that the needle shield 1.1
is in the retracted position PR and the injection needle 2.1 is
inserted into the skin of the patient before the outer body 1.3 is
pushed distally. Thus, so-called wet injections and a spilling of
the medicament before the injection needle 2.1 is inserted into the
skin of the patient are avoided.
[0099] FIG. 5 shows a sectional view of the injection device D at
the end of the injection stroke. The stopper 2.4 connected to the
plunger 2.5 is fully depressed into the inner cavity 2.3.1 of the
pre-filled syringe 2. The support body 1.2 is substantially
received within the hollow outer body 1.3.
[0100] The resilient arm 1.1.2 of the retention and locking means M
is in a mechanical unstressed state and extends essentially
parallel to the central axis A of the safety device 1.
[0101] FIGS. 6A and 6B show two different sectional views of the
injection device D after removal from the injection site. The
sectional plane shown in FIG. 6A extends perpendicularly to the one
shown in FIG. 6B. The needle shield 1.1 is located in a second
advanced position PA2 and surrounds the injection needle 2.1 after
the injection.
[0102] As shown in FIG. 6A, the resilient arm 1.1.2 extends
parallel to the central axis A, so that a second engagement of the
resilient arm 1.1.2 with the catching recess 1.2.3 is avoided. The
resilient arm 1.1.2 may thus pass beyond the catching recess 1.2.3,
so that the needle shield 1.1 in the second advanced position PA2
protrudes the support body 1.2 by a second distance D2 that exceeds
the first distance D1.
[0103] The needle shield 1.1 is locked to the second advanced
position PA2 so that a subsequent exposure of the injection needle
2.1 is prevented. As shown in FIG. 6B, the catch 1.2.2 of the
support body 1.2 abuts a second inward projection 1.2.5 formed to
an inner surface of the needle shield 1.1 to prevent a proximal
movement of the needle shield 1.1 with respect to the support body
1.2.
[0104] FIG. 7 shows a sectional view of an injection device D
according to a second embodiment of the invention in a packaged
state before the injection device D is used to administer the dose
of the medicament contained in the pre-filled syringe 2 to the
patient.
[0105] The safety device 1 according to the second embodiment of
the invention is similar to the one of the first embodiment in both
functionality and design. A needle shield 1.1 of the second
embodiment comprises compact dimensions and covers, compared to the
needle shield 1.1 of the first embodiment, only a relative small
area of the support body 1.2 when arranged in the first advanced
position PA1, the second advanced position PA2 or the retracted
position PR. In particular when the pre-filled syringe 2 is
retained in the support body 1.2 made from a transparent material,
the user may clearly view the content of the pre-filled syringe 2
independent of the positioning of the needle shield 1.1.
[0106] The retention and locking means M of the safety device 1
according to the second embodiment of the invention work similar to
the retention and locking means M of the first embodiment described
before.
[0107] FIG. 8A to 8E illustrate in detail the safety mechanism and
the retention and locking means arranged at the distal end of the
safety device 1 according to the first and second embodiment of the
invention.
[0108] A possible sequence of actions for administering the dose of
the medicament to the patient with the injection device D according
to the first and second embodiment of the invention is described in
the following:
[0109] After removal of the needle cap 2.2 from the distal tip of
the barrel 2.3, the injection device D is arranged at the injection
site, so that the annular flange 1.1.1 rests onto the skin of the
patient. The needle shroud 1.1 is retained in the first advanced
position PA1, wherein, as illustrated in FIG. 8A, the needle shroud
1.1 projects from the distal end of the support body 1.2 by the
first distance D1. The outer body 1.3 is gripped by the user
performing the injection and pushed distally towards the skin
surface. As a distal movement of the outer body 1.3 with respect to
the support body 1.2 is initially prevented by the interaction of
outward projection 1.2.4 with the first inward projection 1.3.3,
the needle shield 1.1 is released from the first advanced position
and pushed in the proximal direction, as illustrated in FIGS. 8A
and 8B. The outwardly deflected resilient arms 1.1.2 disengage the
catching recesses 1.2.3 and unbend due to a material memory effect.
The resilient arm 1.1.2 now extends straight and substantially
parallel to the central axis A of the safety device 1.
[0110] As illustrated in FIG. 8C, the needle shield 1.1 is moved
further in the proximal direction towards the retracted position PR
shown in FIG. 8D, whereby the injection needle 2.1 is inserted into
the skin of the patient.
[0111] After the needle shield 1.1 reached the retracted position
PR pushing the outer body 1.3 in the distal direction causes the
outward projection 1.2.4 to overcome the first inward projection
1.3.3, whereby the outer body 1.3 is released, so that the outer
body 1.3 may move in the distal direction. Simultaneously, the
stopper 2.4 connected to the outer body 1.3 via the plunger 2.5
depresses into the inner cavity 2.3.2, whereby the dose of the
medicament contained in the inner cavity 2.3.2 is expelled through
the injection needle 2.1 and disposed beneath the skin of the
patient.
[0112] When the stopper 2.4 is fully depressed into the inner
cavity 2.3.2, the injection device D is removed from the injection
site. The spring means 1.4 relax and move the needle shroud 1.1 to
the second advanced position PA2 shown in FIG. 8E. The resilient
arm 1.1.2 passes beyond the catching recess 1.2.3, so that the
needle shroud 1.1 projects from the support body 1.2 by the second
distance D2 that is larger than the first distance D1.
[0113] Even if the injection is aborted before the stopper 2.4
reaches the distal end of the inner cavity 2.3.2 and the medicament
is only partially administered, needle safety is still provided
upon removal of the injection device D from the injection site. The
needle shield 1.1 is driven to the second position PA2 shown in
FIG. 8E to cover the injection needle 2.1 after the medication has
been partially delivered.
[0114] FIG. 9 shows an injection device D according to a third
embodiment of the invention in a perspective view before use. The
needle shield 1.1 of the third embodiment is biased in the distal
direction by spring means 1.4 that comprise a plurality of spring
arms 1.4.1 made from a resilient plastics material. A plurality of
longitudinal apertures 1.1.3 corresponding to the spring arms 1.4.1
are formed into the needle shield 1.1. The longitudinal aperture
1.1.3 allows for a deflection of the spring arm 1.4.1 in the radial
outward direction.
[0115] FIG. 10 shows a sectional view of the injection device D
according to the third embodiment before use. The spring arms 1.4.1
are attached to a distal end of the needle shield 1.1. A proximal
end of the spring arm 1.4.1 engages a first ramp 1.2.6 formed to
the outer surface of the support body 1.2. During the injection,
the proximal end of the spring arm 1.4.1 travels along the first
ramp 1.2.6, whereby the spring arm 1.4.1 is deflected outwardly and
stressed to bias the needle shield 1.1 with respect to the support
body 1.2 in the distal direction.
[0116] The resilient arm 1.1.2 of the retention and locking means M
latches to the catching recess 1.2.3 to releasably retain the
needle shield 1.1 in the first advanced position PA1. The resilient
arm 1.1.2 is not pre-tensioned and extends essentially parallel to
the central axis A of the safety device 1. A second ramp 1.2.7 is
formed to the distal end of the support body 1.2 that engages and
deflects the resilient arm 1.1.2 in the radial inward direction
when the needle shield 1.1 is displaced with respect to the support
body 1.2 in the proximal direction, whereby the resilient arm 1.1.2
disengages the catching recess 1.2.3 to release the needle shield
1.1.
[0117] FIGS. 11A and 11B show two cross-sections of the needle
shield 1.1 according to third embodiment of the invention. The
sectional views shown in FIGS. 11A and 11B extend perpendicular to
the central axis A of the safety device 1.
[0118] As can be seen in FIG. 11A, the retention and locking means
M comprise two resilient arms 1.1.2 arranged opposite each other.
The resilient arms 1.1.2 are in a mechanically unstressed state and
latch to the catching recess 1.2.3. According to the third
embodiment, the retention and locking means M comprises two
interlocking elements 1.1.4 respectively arranged in the area
between the two resilient arms 1.1.2.
[0119] The interlocking elements 1.1.4 are arranged opposite to
each other and act as means to lock the two resilient arms 1.1.2 to
each other when the resilient arms 1.1.2 are deflected in the
radial inward direction after the resilient arms 1.1.2 engaged the
second ramp 1.2.7, as illustrated in FIG. 11B. The inwardly
deflected and stressed resilient arms 1.1.2 latch to the
interjacent interlocking elements 1.1.4, so that the deflected
resilient arms 1.1.2 are retained in an inwardly deflected position
and locked together. The two interlocking elements 1.1.4 and the
two resilient arms 1.1.2 form an essentially ring-shaped
interlocked structure S.
[0120] FIG. 12 shows a sectional view of the injection device D
according to the third embodiment of the invention with the needle
shield 1.1 positioned in the retracted position PR.
[0121] The spring arm 1.4.1 engages the first ramp 1.2.6 and is
deflected in the radial outward direction. The spring arm 1.4.1 is
stressed and biases the needle shield 1.1 in the distal
direction.
[0122] The resilient arm 1.1.2 engages the second ramp 1.1.2
arranged at the distal end of the support body 1.2. The second ramp
1.2.7 pushes the resilient arm 1.1.2 radial inwardly, so that the
deflected resilient arm 1.1.2 is oriented with respect to the
central axis A at an acute angle.
[0123] FIG. 13 shows the injection device D according to third
embodiment of the invention after the dose of the medicament
contained in the inner cavity 2.3.2 of the pre-filled syringe 2 has
been administered to the patient. The support body 1.2 is
substantially received within the outer body 1.3 and the stopper
2.4 is fully depressed in the inner cavity 2.3.2.
[0124] FIG. 14 shows the injection device D according to the third
embodiment of the invention in the needle safe state. The needle
shield 1.1 is locked to the second advanced position PA2 and
surrounds the injection needle 2.1 to prevent accidental needle
stick injuries.
[0125] The catch 1.2.2 formed to the distal end of the support body
1.2 latches to the second inward projection 1.2.5 connected to the
needle shield 1.1 to permanently lock the needle shield 1.1 to the
second advanced position PA2, so that a re-exposure of the
injection needle 2.1 is prevented.
[0126] FIG. 15 shows a sectional view of an injection device D
according to a forth embodiment of the invention. The forth
embodiment represents one of many possible examples of injection
devices D that are within the scope of the present invention and
can be viewed as a particularly advantageous combination of the
second and the third embodiment already described herein above.
[0127] In particular, the injection device D according to the forth
embodiment is similar in outer appearance to the injection device D
of the second embodiment and comprises the needle shield 1.1 of
particular compact design. The retaining and locking means M are
designed similar to the injection device D of the third embodiment
and comprise two inwardly deflectable resilient arms 1.1.2 that may
be locked to each other via interjacent locking elements 1.1.4 to
form the interlocked structure S with essentially ring-shaped
cross-section as illustrated in detail in FIGS. 11A and 11B.
[0128] The injection device D according to the third and forth
embodiment of the invention is essentially used during an injection
as described herein above. In particular, a possible sequence of
actions include the removal of the needle cap 2.2 from the distal
tip of the barrel 2.3, the arrangement of the injection device D at
the injection site in manner, so that the annular flange 1.1.1
rests onto the skin of the patient, gripping the outer body 1.3 and
pushing the outer body 1.3 towards the skin surface, whereby the
needle shroud 1.1 first moves from the first advanced position PA1
to the retracted position PR before the outer body 1.3 is
translated in the distal direction to inject the dose of the
medicament. After the injection device D is taken away from the
injection site, the spring means 1.4 relaxes and moves to the
second advanced position PA2.
[0129] FIGS. 16A to 16D illustrate in detail the retention and
locking means M according to the third and forth embodiment of the
invention.
[0130] Before the injection, the needle shield 1.1 is initially
retained in the first advanced position PA1 shown in FIG. 16A. The
needle shield 1.1 is releasably retained in the first advanced
position PA1 by the retaining arm 1.1.2 engaging the catching
recess 1.2.3, wherein the retaining arm 1.1.2 is not mechanically
stressed and extends essentially parallel to the central axis A.
The needle shield 1.1 is released by a linear translation parallel
to the central axis A in the proximal direction, whereby the second
ramp 1.2.7 abuts and deflects the resilient arm 1.1.2 in the radial
inward direction, as illustrated in FIG. 16B. The two deflected
resilient arms 1.1.2 latch to the interlocking elements 1.1.4 to
form the interlocked structure S as illustrated in FIG. 11B.
[0131] During the injection, the needle shield 1.1 moves further in
the proximal direction until the needle shield 1.1 reaches the
retracted position PR shown in FIG. 16C. The injection needle 2.1
protrudes the annular flange 1.1.1 resting on the skin of the
patient and punctures the skin of the patient. After the dose of
the medicament is disposed beneath the skin of the patient, the
injection device is removed from the skin. The spring means 1.4
relaxes and pushes the needle shield 1.1 distally to surround the
used injection needle 2.1 in the second advanced position PA2. The
needle shield 1.1 is permanently locked to the advanced position
PA2 to prevent needle stick injuries after use of the injection
device D.
[0132] FIGS. 17A to 17D illustrate possible arrangements of a
resilient arm 1.2.3 retaining the needle shield 1.1 relative to the
support body 1.2 within the scope of the present invention.
[0133] FIG. 17B shows an arrangement of the resilient arm 1.1.2
formed to the needle shield 1.1. The resilient arm 1.1.2 is
deflected in the radial inward direction to latch to the catching
recess 1.2.3 formed into the distal end of the support body 1.1, so
that the needle shield 1.1 is initially retained in the first
advanced position PA1.
[0134] FIG. 17C shows an arrangement of the resilient arm 1.1.2
formed to the distal end of the support body 1.2. The resilient arm
1.1.2 is deflected in the radial inward direction to latch to the
catching recess 1.2.3 formed into the needle shield 1.1, so that
the needle shield 1.1 is initially retained in the first advanced
position PA1.
[0135] FIG. 17D shows an arrangement of the resilient arm 1.1.2
formed to the distal end of the support body 1.2. The resilient arm
1.1.2 is deflected in the radial outward direction to latch to the
catching recess 1.2.3 formed the needle shield 1.1, so that the
needle shield 1.1 is initially retained in the first advanced
position PA1.
* * * * *