NZ616359B2 - Drug delivery device and cartridge holder for a drug delivery device - Google Patents
Drug delivery device and cartridge holder for a drug delivery device Download PDFInfo
- Publication number
- NZ616359B2 NZ616359B2 NZ616359A NZ61635912A NZ616359B2 NZ 616359 B2 NZ616359 B2 NZ 616359B2 NZ 616359 A NZ616359 A NZ 616359A NZ 61635912 A NZ61635912 A NZ 61635912A NZ 616359 B2 NZ616359 B2 NZ 616359B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- section
- cartridge holder
- drug delivery
- delivery device
- interaction member
- Prior art date
Links
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Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2403—Ampoule inserted into the ampoule holder
- A61M2005/2407—Ampoule inserted into the ampoule holder from the rear
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/178—Syringes
- A61M5/24—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic
- A61M2005/2477—Ampoule syringes, i.e. syringes with needle for use in combination with replaceable ampoules or carpules, e.g. automatic comprising means to reduce play of ampoule within ampoule holder, e.g. springs
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- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31566—Means improving security or handling thereof
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- A61M5/31585—Constructional features or modes of drive mechanisms for piston rods based on rotational translation, i.e. movement of piston rod is caused by relative rotation between the user activated actuator and the piston rod performed by axially moving actuator, e.g. an injection button
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Abstract
coupling arrangement for a cartridge holder of drug delivery device. A drug delivery device is provided comprising a cartridge holder (2) comprising at least one guide track, and a body comprising at least one interaction member. The interaction member is adapted to mechanically cooperate with the at least one guide track. The guide track comprises a first section (12A) and a second section (12B). The path which is defined by the first section (12A) encloses an angle with the longitudinal axis of the device, wherein the second section (12B) encloses an angle with the longitudinal axis of the device which is great than that of the first section. The interaction member is configured to mechanically cooperate with the first section (12A) such that the cartridge holder (2) is axially moved and rotated with respect to the body. The interaction member is configured to mechanically cooperate with the second section (12B) such that the cartridge holder (2) is rotated with respect to the body, whereby an axial movement of the cartridge holder (2) with respect to the body is substantially prevented. at least one guide track. The guide track comprises a first section (12A) and a second section (12B). The path which is defined by the first section (12A) encloses an angle with the longitudinal axis of the device, wherein the second section (12B) encloses an angle with the longitudinal axis of the device which is great than that of the first section. The interaction member is configured to mechanically cooperate with the first section (12A) such that the cartridge holder (2) is axially moved and rotated with respect to the body. The interaction member is configured to mechanically cooperate with the second section (12B) such that the cartridge holder (2) is rotated with respect to the body, whereby an axial movement of the cartridge holder (2) with respect to the body is substantially prevented.
Description
Description
Drug delivery device and cartridge holder for a drug delivery device
This disclosure relates to a drug delivery device. The disclosure further relates to
a cartridge holder for a drug delivery device.
In a drug delivery device, often, a bung within a cartridge containing a plurality of
doses of a drug is displaced by a piston rod. Thereby, a dose of the drug is
expelled from the cartridge. The cartridge is often stabilized by a cartridge holder.
A drug delivery device is described in document EP 1 923 083 A1, for example.
It is an object of the present disclosure to provide an improved drug delivery
device, for example a device with increased comfort for the user. Furthermore, a
cartridge holder is provided facilitating provision of an improved drug delivery
device.
It is an additional or alternative object of the present invention to provide the
public with a useful choice.
This object may be achieved by the subject matter of the independent claims.
Advantageous embodiments and refinements are subject matter of the dependent
claims.
The present invention provides a cartridge holder for a drug delivery device, the
cartridge holder comprising at least one guide track adapted and arranged to
mechanically cooperate with an interaction member of a body of the device,
wherein the guide track comprises a first section and a second section, wherein
the path which is defined by the first section encloses an angle with the
longitudinal axis of the device, wherein the angle which is enclosed by the path
defined by the first section with the longitudinal axis is smaller than the angle
which is enclosed by the path defined by the second section with the longitudinal
axis, wherein, for connecting the cartridge holder to the body, the cartridge holder
is rotated by a greater angle with respect to the body when the interaction
member mechanically cooperates with the first section than when the interaction
member mechanically cooperates with the second section.
Comprises/comprising and grammatical variations thereof when used in this
specification are to be taken to specify the presence of stated features, integers,
steps or components or groups thereof, but do not preclude the presence or
addition of one or more other features, integers, steps, components or groups
thereof.
The present invention further provides a drug delivery device comprising the
cartridge holder according to the invention, a body comprising at least one
interaction member adapted and arranged to mechanically cooperate with the at
least one guide track.
One aspect relates to a drug delivery device. The device may comprise a
cartridge holder. The cartridge holder may comprise at least one, preferably two
or more, guide tracks. The device may comprise a body. The body may comprise
at least one, preferably two or more, interaction members. The interaction
member may be adapted and arranged to mechanically cooperate with the at
least one guide track. The guide track expediently comprises a first section and a
second section. The first section may run obliquely with respect to the longitudinal
axis of the device. In particular, the path which is defined by the first section
encloses an angle with the longitudinal axis of the device. The second section
may run less obliquely with respect to the longitudinal axis of the device than the
first section. In particular, the angle which is enclosed by the path defined by the
first section with the longitudinal axis of the device may be smaller than
the angle which is enclosed by the path defined by the second section with the
longitudinal axis of the device. The second section may run transversally with respect to
the longitudinal axis of the device. For, preferably releasably, connecting the cartridge
holder to the body, the interaction member may be configured to mechanically
cooperate with the first section such that the cartridge holder is axially moved and
rotated with respect to the body. Furthermore, for preferably releasably, connecting the
cartridge holder to the body, the interaction member may be configured to mechanically
cooperate with the second section such that the cartridge holder is rotated with respect
to the body. Thereby, axial movement of the cartridge holder with respect to the body
may be prevented.
When the interaction member mechanically cooperates with the guide track, the
cartridge holder performs an inter alia rotatory movement. In particular, the rotatory
movement is performed already when the cartridge holder is moved towards the body
for connecting the cartridge holder to the body, i.e. when the interaction member
mechanically cooperates with the first section. The rotatory movement is a movement
very familiar to the user as it is known from ordinary screw thread connections. Thus,
the user can feel very familiar with the connecting movement. In particular, this
connecting movement of the cartridge holder may help in that the user can easily trust
in the safe connection of the cartridge holder and the body. In this way, provision of a
device comprising increased user comfort is facilitated.
Mechanical cooperation of the interaction member and the first section may be
succeeded by mechanical cooperation of the interaction member and the second
section for connecting the cartridge holder and the body. Axial movement of the
cartridge holder with respect to the body may be prevented when the interaction
member mechanically cooperates with the second section. This may help to indicate to
the user that the cartridge holder is close to afinal position with respect to the body, in
particular to a position where the cartridge holder is firmly connected to the body. User
comfort may be further increased in this way.
The interaction member and the first and second section may comprise a dimension
such that the interaction member abuts the walls of the respective section any time
during the connection operation. In particular, the interaction member may exactly fit
into the respective section. In this way, a smooth connection movement of the cartridge
holder may be facilitated which further helps to increase the user comfort.
According to an embodiment, the cartridge holder is rotated only in a first direction with
respect to the body during mechanical cooperation of the interaction member with the
first and second section.
Accordingly, during the connection operation, the cartridge holder may be rotated in the
same direction. No opposite rotation, in particular no change of the rotation direction, of
the cartridge holder may be necessary for connecting the cartridge holder to the body,
which could lead to the user erroneously believing that the cartridge holder is not safely
connected to the body oreven released from the body.
According to an embodiment, the second section comprises an angular end stop. The
angular end stop may comprise a sidewall of the second section. The angular end stop
may be adapted and arranged to prevent further relative rotation of the cartridge holder
and the body in the first direction by mechanical cooperation of the angular end stop
with the interaction member.
The angular end stop may be configured for indicating the final position of the cartridge
holder with respect to the body. Hence, when the user can no longer rotate the cartridge
holder in the first direction with respect to the body, he automatically knows that the
cartridge holder was firmly connected to the body. User comfort may be further
increased in this way.
According to an embodiment, the cartridge holder is rotated with respect to the body by
less than one revolution when the interaction member mechanically cooperates with the
first section. The cartridge holder may be rotated with respect to the body by less than
one revolution when the interaction member mechanically cooperates with the second
section.
The cartridge holder may be rotated by a minimum angle of 5degrees when the
interaction member mechanically cooperates with the first section. The cartridge holder
may be rotated by a maximum angle of 120 degrees when the interaction member
mechanically cooperates with the first section. The cartridge holder may be rotated by
an angle between 10 degrees and 50 degrees, for example. Preferably, the cartridge
holder is rotated by an angle of 30 degrees when the interaction member mechanically
cooperates with the first section.
The cartridge holder may be rotated by a minimum angle of 5degrees when the
interaction member mechanically cooperates with the second section. The cartridge
holder may be rotated by a maximum angle of 90 degrees when the interaction member
mechanically cooperates with the second section. The cartridge holder may be rotated
by an angle between 10 and 20 degrees, for example, when the interaction member
mechanically cooperates with the second section. Preferably, the cartridge holder is
rotated by an angle of 15 degrees, when the interaction member mechanically
cooperates with the second section.
Rotating the cartridge holder by less than one revolution during the connection
operation mayfurther help to increase the user comfort, as the user only has to perform
small and, thus, easily manageable movements of the cartridge holder for safely
connecting the cartridge holder to the body.
According to an embodiment, the cartridge holder is rotated by a greater angle with
respect to the body when the interaction member mechanically cooperates with the first
section than when the interaction member mechanically cooperates with the second
section.
According to an embodiment, the cartridge holder is rotated by a greater angle with
respect to the body when the interaction member mechanically cooperates with the
second section than when the interaction member mechanically cooperates with the first
section.
According to an embodiment, the cartridge holder is rotated by the equal angle with
respect to the body when the interaction member mechanically cooperates with the
second section and when the interaction member mechanically cooperates with the first
section.
According to an embodiment, for disconnecting the cartridge holder and the body, the
interaction member is configured to mechanically cooperate with the second section
and with the first section of the guide track such that the cartridge holder is rotated in a
second direction with respect to the body. The second direction may be opposite to the
first direction.
Mechanical cooperation of the interaction member and the second section may be
succeeded by mechanical cooperation of the interaction member and the first section
for disconnecting the cartridge holder and the body. For disconnecting the cartridge
holder and the body, a reverse movement of the cartridge holder may be required as
compared to the connecting movement. No additional disconnecting movements may
be required. In this way, provision of a drug delivery device providing increased user
comfort may be facilitated.
According to an embodiment, the guide track comprises a groove. The at least one
guide track may be arranged on an outer surface of the cartridge holder. Alternatively,
the guide track may be arranged on the body, e.g. on an inner surface of the body. The
interaction member may comprise a protrusion or pin. The at least one interaction
member may be arranged on an inner surface of the body. Alternatively, the interaction
member may be arranged on the cartridge holder, e.g. on an outer surface of the
cartridge holder.
According to an embodiment, the guide track is arranged in the proximal end section of
the cartridge holder. The proximal end section may comprise at least one indentation.
The guide track may be arranged such that the distal end of the indentation passes over
into the proximal end of the first section of the guide track.
The indentation may comprise an angular extent which is greater than the angular
extent of the first section. The indentation may comprise a sloped edge which is
configured to facilitate introducing the interaction member into the indentation. By
providing the indentation in the proximal end section, the interaction member may be
easily guideable into the first section of the guide track once introduced in the
indentation.
According to an embodiment, the first section and the second section of the guide track
pass over into one another.
In this way, a continuous rotatory movement of the cartridge holder, in particular a
rotation of the cartridge holder without abrupt movements or interruptions, may be
enabled when the cartridge holder is connected to the device.
According to an embodiment, the cartridge holder may comprise two different guide
tracks. The guide tracks may be arranged oppositely with respect to one another. The
body may comprise two interaction members. The interaction members may be
arranged oppositely with respect to one another.
By providing two guide tracks and two interaction members a safe and easily
manageable connection of the cartridge holder and the body may be enabled.
A further aspect relates to a cartridge holder for a drug delivery device. The cartridge
holder may comprise the previously described cartridge holder. The cartridge holder
may comprise at least one guide track. The guide track may comprise a first section.
The first section may run obliquely with respect to the longitudinal axis of the cartridge
holder. The guide track may comprise a second section. The second section may run
less obliquely with respect to the longitudinal axis of the cartridge holder than the first
section. The second section may run transversally with respect to the longitudinal axis
of the cartridge holder.
The path which is defined by the first section may enclose an angle with the longitudinal
axis of the cartridge holder. The angle which is enclosed by the path defined by the first
section with the longitudinal axis may be smaller than the angle which is enclosed by
the path defined by the second section with the longitudinal axis.
The guide track may enable a continuous rotatory movement of the cartridge holder, in
particular a rotation without abrupt movements or interruptions, when the cartridge
holder is connected to the device. The rotatory movement may be performed already
when the cartridge holder is moved towards the device. Such a rotatory movement is
known from ordinary screw thread connections and, thus, it is very familiar to the user.
Accordingly, the connecting movement of the cartridge holder may help in that the user
can easily trust in the safe connection of the cartridge holder and the device. In this way,
provision of a device comprising increased user comfort is facilitated.
Of course, features described above in connection with different aspects and
embodiments may be combined with each other and with features described below.
Further features and refinements become apparent from the following description of the
exemplary embodiments in connection with the accompanying figures.
Figure 1schematically shows a sectional side view of a drug delivery device,
Figures 2A and 2B schematically show a perspective side view of the drug delivery
device of Figure 1,
Figure3schematically shows a perspective side view of a body,
Figures 4A and 4B schematically show a perspective side view of a cartridge holder.
Like elements, elements of the same kind and identically acting elements may be
provided with the same reference numerals in the figures.
In Figures 1, 2A and 2B a drug delivery device 1 is shown. The drug delivery device 1
comprises a body 3.The drug delivery device 1and the body 3 have a distal end and a
proximal end. The distal end is indicated by arrow 8.The proximal end is indicated by
arrow 9.The term "distal end" designates that end of the drug delivery device 1ora
component thereof which is or is to be arranged closest to a dispensing end of the drug
delivery device 1.The term "proximal end" designates that end of the device 1ora
component thereof which is or is to be arranged furthest away from the dispensing end
of the device 1.The distal end and the proximal end are spaced apart from one another
in the direction of an axis. The axis may be the longitudinal axis 14 of the device 1 (see
Figure 1).
The drug delivery device 1comprises a cartridge holder 2.The cartridge holder 2
comprises engaging means 5, e.g. a thread, for releasably connecting a needle
assembly (not explicitly shown) to the cartridge holder 2.A cap 21 (see Figures 2A and
2B) can be secured to the drug delivery device 1for protecting the device 1,and, in
particular, the cartridge holder 2 from environmental influences.
The drug delivery device 1comprises a cartridge 6.The cartridge 6 is retained within
the cartridge holder 2.The cartridge holder 2 stabilizes the position of the cartridge 6
mechanically. The cartridge 6 contains a drug 11, preferably a plurality of doses of the
drug 11.
The drug 11 may be a fluid drug. The term "drug", as used herein, means a
pharmaceutical formulation containing at least one pharmaceutically active compound,
wherein in one embodiment the pharmaceutically active compound has a molecular
weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, a
DNA, a RNA, , an enzyme, an antibody or a fragment thereof, a hormone or an
oligonucleotide, ora mixture of the above-mentioned pharmaceutically active compound,
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,
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,
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 exedin-3 or exedin-4 or an
analogue orderivative of exedin-3 or exedin-4.
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.
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; Β29-Ν-(ω-
carboxyheptadecanoyl)-des(B30) human insulin and B29-N-(u-carboxyheptadecanoyl)
human insulin.
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-Val-Arg-Leu-Phe-
lle-Glu-Trp-Leu-Lys-Asn-Gly-Gly-Pro-Ser-Ser-Gly-Ala-Pro-Pro-Pro-Ser-NH2.
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 [Asp28] Exendin-4(1-39),
des Pro36 [lsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, lsoAsp28] 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, lsoAsp28] Exendin-4(1-39); or
des Pro36 [Asp28] Exendin-4(1-39),
des Pro36 [lsoAsp28] Exendin-4(1-39),
des Pro36 [Met(O)14, Asp28] Exendin-4(1-39),
des Pro36 [Met(O)14, lsoAsp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, Asp28] Exendin-4(1-39),
des Pro36 [Trp(O2)25, lsoAsp28] 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, lsoAsp28] Exendin-4(1-39),
wherein the group -Lys6-NH2 may be bound to the C-terminus of the Exendin-4
derivative;
oran Exendin-4 derivative of the sequence
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;
or a pharnnaceutically acceptable salt or solvate of any one of the afore-mentioned
Exedin-4 derivative.
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.
A polysaccharide is for example a glucosanninoglycane, 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.
Antibodies are globular plasma proteins (-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.
The Ig monomer isa"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 70-1 10 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 β sheets create a"sandwich" shape, held together by interactions between
conserved cysteines and other charged amino acids.
There are five types of mammalian Ig heavy chain denoted by ,δ,ε,γ,and µ .The type
of heavy chain present defines the isotype of antibody; these chains are found in IgA,
IgD, IgE, IgG, and IgM antibodies, respectively.
Distinct heavy chains differ in size and composition; a and γ contain approximately 450
amino acids and δ approximately 500 amino acids, while µ and ε have approximately
550 amino acids. Each heavy chain has two regions, the constant region (CH) and the
variable region (V ). 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 γ,a and δ have a constant region composed of three tandem Ig domains, and a
hinge region for added flexibility; heavy chains µ and ε 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.
In mammals, there are two types of immunoglobulin light chain denoted by λ and κ.A
light chain has two successive domains: one constant domain (CL) and one variable
domain (VL). The approximate length of a light chain is 211to 217 amino acids. Each
antibody contains two light chains that are always identical; only one type of light chain,
Kor λ, is present per antibody in mammals.
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.
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).
Pharmaceutically acceptable salts are for example acid addition salts and basic salts.
Acid addition salts are e.g. HCI 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-C6-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.
Pharmaceutically acceptable solvates are for example hydrates.
The drug delivery device 1may be a pen-type device, in particular a pen-type injector.
The device 1may be configured for dispensing fixed doses of the drug 11, i.e. doses
which may not be varied by a user, or user-settable doses of the drug 11.A bung 7 is
slideably retained within the cartridge 6.The bung 7 seals the cartridge 6 proximally.
Movement of the bung 7 in the distal direction with respect to the cartridge 6 causes the
drug 11to be dispensed from the cartridge 6.
The body 3 houses a drive mechanism 4, 10, 19 of the device 1.The drive mechanism
4, 10, 19 drives a piston rod 17 in the distal direction with respect to the body 3for
dispensing a dose of the drug 11.The drive mechanism 4, 10, 19 prevents proximal
movement of the piston rod 17 with respect to the body 3 during a dose setting
operation. A bearing member 15 is located at the distal end of the piston rod 17 to abut
the proximal face of the bung 7.
Figure3schematically shows a perspective side view of a body 3.
The cartridge holder 2 is releasably connected to the body3of the drug delivery device
1.The body 3 comprises two interaction members 13,wherein only one of the
interaction members 13 is shown in Figure 3.Alternatively, the body 3 can comprise
only one interaction member 13 or even more, e.g. three orfour interaction members 13.
The interaction members 13 are arranged in the distal end section of the body 3, i.e. the
end section which is to be connected to the cartridge holder 2.The interaction members
13 are arranged on the inner surface of the body 3.The two interaction members 13 are
arranged oppositely with respect to one another.
The interaction member 13 comprises a pin. The pin protrudes radially inwards from the
inner surface of the body 3. In the embodiment shown in Figure 3, the angular extent of
the interaction member 13 is greater than its axial extent. However, the situation may be
vice versa, as well, i.e. the axial extent of the interaction member 13 may be greater
than its angular extent. Alternatively, the interaction member 13 can comprise a square
or circular shape. The respective interaction member 13 mechanically cooperates with a
corresponding guide track 12 of the cartridge holder 2.
Figures 4A and 4B schematically show a perspective side view of the cartridge holder 2.
The cartridge holder 2 comprises two guide tracks 12.Alternatively, the cartridge holder
2 can comprise only one guide track 12 or even more, e.g. three orfour guide tracks 12.
The number of guide tracks 12 corresponds to the number of interaction members 13.
The guide tracks 12 are arranged in the proximal end section of the cartridge holder 2,
i.e. the end section which is to be connected to the body 3.The guide tracks 12 are
arranged on the outer surface of the cartridge holder 12.The guide tracks 12 are
grooves. The two guide tracks 12 are arranged oppositely with respect to one another.
The respective guide track 12 (see Figure 4B) comprises a first section 12A. The guide
track 12 comprises a second section 12B. The first section 12A runs obliquely with
respect to the longitudinal axis 14 (see Figure 1)of the device 1. In particular, the path
defined by the first section 12A encloses an angle with the longitudinal axis 14 of the
device 1.The angle which is enclosed by the path defined by the first section 12A with
the longitudinal axis 14 amounts to about 45 degrees in the embodiment shown in
Figures 4A and 4B. However, also other angles are conceivable, e.g. the angle can
amount to a minimum value of 10 degrees or a maximum value of 120 degrees. The
second section 12B runs less obliquely with respect to the longitudinal axis 14 than the
first section 12A. The angle enclosed by the path defined by the first section 12A with
the longitudinal axis 14 is smaller than the angle enclosed by the path defined by the
second section 12Bwith the longitudinal axis 14. The angle which is enclosed by the
path defined by the second section 12Bwith the longitudinal axis 14 amounts to 90
degrees in the embodiments shown in Figures 4A and 4B.
The first section 12A and the second section 12Bform a continuous guide track 12. In
other words, for connecting ordisconnecting the cartridge holder 2 to the body 3,the
interaction member 13 can pass from the first section 12A directly into the second
section 12B and vice versa.
The second section 12B comprises an angular stop face 20. The angular stop face 20 is
formed by a sidewall of the second section 12B. When the interaction member 13
mechanically cooperates with the angular stop face 20, further rotation of the cartridge
holder 2 with respect to the body 3for connecting the cartridge holder 2 and the body 3
is prevented.
The cartridge holder 2further comprises two indentations 16. The indentations 16 are
arranged in the proximal end section of the cartridge holder 2. The two indentations 16
are arranged oppositely with respect to one another. The respective indentation 16
comprises sloped edges. The indentation 16 comprises an angular extent which is
greater than the angular extent of the first section 12A. Alternatively, the indentation 16
may comprise an angular extent which is smaller than the angular extend of the first
section 12A. The distal end of the respective indentation 16 passes over into the
proximal end of the first section 12A of the respective guide track 12.
For connecting the cartridge holder 2 to the body 3,the cartridge holder 2 is moved, in
particular at least one of axially moved and rotated, with respect to the body 3.The
cartridge holder 2 is moved with respect to the body 3 until the interaction member 13
mechanically cooperates with the indentation 16. Upon further movement of the
cartridge holder 2 with respect to the body 3,the interaction member is brought into
mechanical cooperation with the first section 12A. When the interaction member 13
mechanically cooperates with the first section 12A, the cartridge holder 2 is moved
proximally with respect to the body 3 such that the first section 12A slides along the
interaction member 13.Thereby, the cartridge holder 2 is rotated in a first direction with
respect to the body 2. In this embodiment, the cartridge holder 2 is rotated by an angle
of about 30 degrees with respect to the body while the interaction member 13
mechanically cooperates with the first section 12A. The angle is defined by the angle
which the path defined by the first section 12A encloses with the longitudinal axis 14 as
described above.
At the distal end of the first section 12A, the first section 12A directly passes over into
the second section 12B. At the distal end of the first section 12A, the interaction
member 13 is brought into mechanical cooperation with a distal and a proximal wall 22,
23 (see Figure 4B) of the second section 12B such that further axial movement of the
cartridge holder 2with respect to the body 3 is prevented. In particular, mechanical
cooperation of the interaction member 13 with the distal wall 23 prevents further
proximal movement of the cartridge holder 2with respect to the body 3 during the
connection operation.
Accordingly, the cartridge holder 2 is further rotated in the first direction, but no longer
axially moved with respect to the body 3.The cartridge holder 2 is rotated such that the
second section 12B slides along the interaction member 13 until the interaction member
13 mechanically cooperates with the angular end stop 20. The cartridge holder 2 is
rotated in the same direction when the interaction member 13 mechanically cooperates
with the first and the second section 12A, 12B for connecting the cartridge holder 2 to
the body 3.
When the interaction member 13 mechanically cooperates with the angular end stop 20,
further rotation of the cartridge holder 2 in the first direction is prevented. When the
interaction member 13 mechanically cooperates with the angular end stop 20, the
cartridge holder 2 is firmly connected to the body 3. Mechanical cooperation of the
interaction member 13 and the angular end stop 20 can provide a tactile feedback
indicating to the user that the cartridge holder 2 is firmly connected to the body 3.
For disconnecting the cartridge holder 2 and the body 3,the cartridge holder 2 is rotated
in a second direction. The second direction is opposite to the first direction. Thereby, the
second section 12B slides along the interaction member 13 of the body 3, axial
movement of the cartridge holder 2with respect to the body 3 being prevented by
mechanical cooperation of the interaction member 13 with the distal and proximal walls
22, 23 of the second section 12B.
Upon further rotation of the cartridge holder 2 in the second direction, the first section
12A slides along the interaction member 13. When the first section 12A slides along the
interaction member 13,the cartridge holder 2 is moved distally with respect to the body
3 for disconnecting the cartridge holder 2 and the body 3.
The interaction member 13 as well as the first section 12A and the second section 12B
comprise a dimension such that the interaction member 13 mechanically cooperates
with the walls of the sections 12A, 12B at any time during the connecting and during the
disconnection operation. In particular, when the interaction member 13 mechanically
cooperates with the first section, the interaction member 13 abuts the side walls of the
first section 12A. When the interaction member 13 mechanically cooperates with the
second section, it abuts the distal and proximal walls 22, 23 of the second section 12B.
As the first and second section 12A, 12B pass over into one another, i.e. the side walls
of the first section 12A pass over into the distal and proximal walls 22, 23 of the second
section 12B, the interaction member 13 is at any time in mechanical contact with the
wall of one of the sections 12A, 12B during the connection and the disconnection
operation.
Reference Numerals
1 Drug delivery device
Cartridge holder
3 Body
Drive mechanism
Engaging means
Cartridge
7 Bung
8 Distal end
9 Proximal end
Drive mechanism
11 Drug
12 Guide track
12A First section
12B Second section
Interaction member
14 Longitudinal axis
Bearing member
16 Indentation
Piston rod
19 Drive mechanism
Angular end stop
21 Cap
22 Proximal wall
23 Distal wall
Claims (16)
1. A cartridge holder for a drug delivery device, the cartridge holder comprising at least one guide track adapted and arranged to mechanically cooperate with an interaction member of a body of the device, wherein the guide track comprises a first section and a second section, wherein the path which is defined by the first section encloses an angle with the longitudinal axis of the device, wherein the angle which is enclosed by the path defined by the first section with the longitudinal axis is smaller than the angle which is enclosed by the path defined by the second section with the longitudinal axis, wherein, for connecting the cartridge holder to the body, the cartridge holder is rotated by a greater angle with respect to the body when the interaction member mechanically cooperates with the first section than when the interaction member mechanically cooperates with the second section.
2. A drug delivery device comprising the cartridge holder according to claim 1, a body comprising at least one interaction member adapted and arranged to mechanically cooperate with the at least one guide track.
3. The drug delivery device according to claim 2, wherein the cartridge holder is rotated in a first direction with respect to the body during mechanical cooperation of the interaction member with the first and second section.
4. The drug delivery device according to claim 3, wherein the second section comprises an angular end stop adapted and arranged to prevent further relative rotation of the cartridge holder and the body in the first direction by mechanical cooperation of the angular end stop with the interaction member.
5. The drug delivery device according to any of the previous claims, wherein the cartridge holder is rotated with respect to the body by less than one revolution when the interaction member mechanically cooperates with the first section, and wherein the cartridge holder is rotated with respect to the body by less than one revolution when the interaction member mechanically cooperates with the second section.
6. The drug delivery device according to any one of the previous claims, wherein, for connecting the cartridge holder to the body, the interaction member is configured to mechanically cooperate with the first section such that the cartridge holder is axially moved and rotated with respect to the body, and the interaction member is configured to mechanically cooperate with the second section such that the cartridge holder is rotated with respect to the body, whereby an axial movement of the cartridge holder with respect to the body is prevented.
7. The drug delivery device according to any one of claims 3 to 6, wherein, for disconnecting the cartridge holder and the body, the interaction member is configured to mechanically cooperate with the second section and with the first section of the guide track such that the cartridge holder is rotated in a second direction with respect to the body, the second direction being opposite to the first direction.
8. The drug delivery device according to any one of the previous claims, wherein the first section and the second section of the guide track pass over into one another.
9. The drug delivery device according to any one of the previous claims, wherein the at least one guide track is arranged on an outer surface of the cartridge holder.
10. The drug delivery device according to any one of the previous claims, wherein the guide track is arranged in the proximal end section of the cartridge holder, wherein the proximal end section comprises at least one indentation, the guide track being arranged such that the distal end of the indentation passes over into the proximal end of the first section of the guide track.
11. The drug delivery device according to any one of the previous claims, wherein the at least one interaction member is arranged on an inner surface of the body.
12. The drug delivery device according to any one of the previous claims, wherein the at least one interaction member comprises a protrusion.
13. The drug delivery device according to any one of the previous claims, wherein the at least one guide track comprises a groove.
14. The drug delivery device according to any one of the previous claims, wherein the cartridge holder comprises two different guide tracks, the guide tracks being arranged oppositely with respect to one another, and wherein the body comprises two different interaction members, the interaction members being arranged oppositely with respect to one another.
15. A cartridge holder for a drug delivery device, the cartridge holder substantially as herein described with reference to any embodiment shown in the accompanying drawings.
16. A drug delivery device substantially as herein described with reference to any embodiment shown in the accompanying drawings. SANOFI-AVENTIS DEUTSCHLAND GMBH WATERMARK PATENT AND TRADE MARKS ATTORNEYS P38081NZ00
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11165047 | 2011-05-06 | ||
EP11165047.9 | 2011-05-06 | ||
PCT/EP2012/058182 WO2012152668A1 (en) | 2011-05-06 | 2012-05-04 | Drug delivery device and cartridge holder for a drug delivery device |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ616359A NZ616359A (en) | 2015-02-27 |
NZ616359B2 true NZ616359B2 (en) | 2015-05-28 |
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