NZ619087B2 - Cartridge holder assembly for drug delivery devices - Google Patents
Cartridge holder assembly for drug delivery devices Download PDFInfo
- Publication number
- NZ619087B2 NZ619087B2 NZ619087A NZ61908712A NZ619087B2 NZ 619087 B2 NZ619087 B2 NZ 619087B2 NZ 619087 A NZ619087 A NZ 619087A NZ 61908712 A NZ61908712 A NZ 61908712A NZ 619087 B2 NZ619087 B2 NZ 619087B2
- Authority
- NZ
- New Zealand
- Prior art keywords
- cartridge holder
- drug delivery
- interconnection
- cartridge
- latch element
- Prior art date
Links
- 239000003814 drug Substances 0.000 title claims abstract description 25
- 229940079593 drugs Drugs 0.000 title description 10
- 229940089114 Drug Delivery Device Drugs 0.000 claims abstract description 22
- 230000000875 corresponding Effects 0.000 claims abstract description 18
- HTQBXNHDCUEHJF-XWLPCZSASA-N Exendin-4 Chemical compound C([C@@H](C(=O)N[C@@H]([C@@H](C)CC)C(=O)N[C@@H](CCC(O)=O)C(=O)N[C@@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCCN)C(=O)N[C@@H](CC(N)=O)C(=O)NCC(=O)NCC(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(=O)N[C@@H](CO)C(=O)NCC(=O)N[C@@H](C)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N1[C@@H](CCC1)C(=O)N[C@@H](CO)C(N)=O)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CCCNC(N)=N)NC(=O)[C@@H](NC(=O)[C@H](C)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCC(O)=O)NC(=O)[C@H](CCSC)NC(=O)[C@H](CCC(N)=O)NC(=O)[C@H](CCCCN)NC(=O)[C@H](CO)NC(=O)[C@H](CC(C)C)NC(=O)[C@H](CC(O)=O)NC(=O)[C@H](CO)NC(=O)[C@@H](NC(=O)[C@H](CC=1C=CC=CC=1)NC(=O)[C@@H](NC(=O)CNC(=O)[C@H](CCC(O)=O)NC(=O)CNC(=O)[C@@H](N)CC=1NC=NC=1)[C@@H](C)O)[C@@H](C)O)C(C)C)C1=CC=CC=C1 HTQBXNHDCUEHJF-XWLPCZSASA-N 0.000 description 44
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- GFIJNRVAKGFPGQ-LIJARHBVSA-N leuprolide Chemical compound CCNC(=O)[C@@H]1CCCN1C(=O)[C@H](CCCNC(N)=N)NC(=O)[C@H](CC(C)C)NC(=O)[C@@H](CC(C)C)NC(=O)[C@@H](NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)CC1=CC=C(O)C=C1 GFIJNRVAKGFPGQ-LIJARHBVSA-N 0.000 description 1
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- 125000001116 prolino group Chemical group [H]OC(=O)C1([H])N(*)C([H])([H])C([H])([H])C1([H])[H] 0.000 description 1
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- MAKUBRYLFHZREJ-JWBQXVCJSA-M sodium;(2S,3S,4R,5R,6R)-3-[(2S,3R,5S,6R)-3-acetamido-5-hydroxy-6-(hydroxymethyl)oxan-2-yl]oxy-4,5,6-trihydroxyoxane-2-carboxylate Chemical compound [Na+].CC(=O)N[C@@H]1C[C@H](O)[C@@H](CO)O[C@H]1O[C@@H]1[C@@H](C([O-])=O)O[C@@H](O)[C@H](O)[C@H]1O MAKUBRYLFHZREJ-JWBQXVCJSA-M 0.000 description 1
- 239000000243 solution Substances 0.000 description 1
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- VXKHXGOKWPXYNA-PGBVPBMZSA-N triptorelin Chemical compound C([C@@H](C(=O)N[C@H](CC=1C2=CC=CC=C2NC=1)C(=O)N[C@@H](CC(C)C)C(=O)N[C@@H](CCCNC(N)=N)C(=O)N1[C@@H](CCC1)C(=O)NCC(N)=O)NC(=O)[C@H](CO)NC(=O)[C@H](CC=1C2=CC=CC=C2NC=1)NC(=O)[C@H](CC=1N=CNC=1)NC(=O)[C@H]1NC(=O)CC1)C1=CC=C(O)C=C1 VXKHXGOKWPXYNA-PGBVPBMZSA-N 0.000 description 1
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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
- A61M2005/2485—Ampoule holder connected to rest of syringe
- A61M2005/2492—Ampoule holder connected to rest of syringe via snap connection
-
- 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
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31533—Dosing mechanisms, i.e. setting a dose
- A61M5/31535—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose
- A61M5/31543—Means improving security or handling thereof, e.g. blocking means, means preventing insufficient dosing, means allowing correction of overset dose piston rod reset means, i.e. means for causing or facilitating retraction of piston rod to its starting position during cartridge change
-
- 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
- A61M5/31—Details
- A61M5/315—Pistons; Piston-rods; Guiding, blocking or restricting the movement of the rod or piston; Appliances on the rod for facilitating dosing ; Dosing mechanisms
- A61M5/31565—Administration mechanisms, i.e. constructional features, modes of administering a dose
- A61M5/31576—Constructional features or modes of drive mechanisms for piston rods
- A61M5/31583—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
- 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
Abstract
Disclosed is a drug delivery device for administering a predefined dose of a medicament from a cartridge. That has a reliable mechanical inter-connection between the cartridge holder and the device body. The drug delivery device comprises a housing that comprises a body to accommodate a drive mechanism, a cartridge holder to accommodate a cartridge having a piston slidably disposed therein in an axial direction (z), and an interconnection (59) between cartridge holder and body. The interconnection has at least one displaceable or resiliently deformable latch element (68) to mate with a corresponding bearing (54), wherein the latch element (68) is displaceable or deformable in a direction (z, w) extending substantially parallel to a circumferential side wall (52, 65) of the body or cartridge holder. The cartridge holder and body comprise an insert portion and a corresponding receptacle portion for establishing an at least partially interleaved interconnection of cartridge holder and body. The receptacle portion comprises the at least one bearing extending in a lateral plane (x, y) with respect to a tubular shape of cartridge holder and/or body and extending radially inwardly from an inside facing side wall section of the receptacle. The bearing comprises at least one axial through opening to receive the latch element. ism, a cartridge holder to accommodate a cartridge having a piston slidably disposed therein in an axial direction (z), and an interconnection (59) between cartridge holder and body. The interconnection has at least one displaceable or resiliently deformable latch element (68) to mate with a corresponding bearing (54), wherein the latch element (68) is displaceable or deformable in a direction (z, w) extending substantially parallel to a circumferential side wall (52, 65) of the body or cartridge holder. The cartridge holder and body comprise an insert portion and a corresponding receptacle portion for establishing an at least partially interleaved interconnection of cartridge holder and body. The receptacle portion comprises the at least one bearing extending in a lateral plane (x, y) with respect to a tubular shape of cartridge holder and/or body and extending radially inwardly from an inside facing side wall section of the receptacle. The bearing comprises at least one axial through opening to receive the latch element.
Description
Cartridge holder assembly for Drug Delivery Devices
Description
Field of the Invention
The present invention relates to the field of drug delivery s and in particular
to injection s such like pen-type injectors for administering a predefined dose
of a liquid medicament.
Background and Prior Art
Drug delivery devices ng for multiple dosing of a required dosage of a liquid
medicament, such as liquid drugs, and further providing administration of the
medicament to a patient, are as such well-known in the art. Generally, such
s have substantially the same purpose as that of an ordinary syringe.
Drug delivery devices of this kind have to meet a number of user specific
requirements. For instance in case of those with diabetes, many users will be
physically infirm and may also have impaired vision. Therefore, these devices need
to be robust in construction, yet easy to use, both in terms of the manipulation of
the parts and understanding by a user of its operation. Further, the dose g
must be easy and unambiguous and where the device is to be disposable rather
than le, the device should be inexpensive to manufacture and easy to
dispose. In order to meet these ements, the number of parts and steps
required to assemble the device and an overall number of material types the device
is made from have to be kept to a minimum.
Typically, the medicament to be administered is provided in a dge that has a
3O moveable piston or bung mechanically interacting with a piston rod of a drive
mechanism of the drug delivery device. By applying thrust to the piston in a distal
direction, a predefined amount of the medicinal fluid is expelled from the cartridge.
In particular for elderly or ally infirm users, the overall handling of the device
in a home medication environment should be simple and highly reliable. As for
instance illustrated in Figures 1 to 3, drug delivery devices and in particular pen-
type injectors typically comprise a multi—component housing 10. Here, a distal end
section typically serves as a cartridge holder 12. The cartridge holder 12 comprises
a threaded socket 16 at its distal end to receive a needle ly 18 having a
correspondingly threaded needle hub 20 and a double tipped injection needle 22.
The cartridge holder 12 further comprises an insert portion 26 at its proximal end
section, by way of which the cartridge holder 12 can be at least partially inserted
into a correspondingly shaped distal acle of a al housing component
14 of the drug delivery device, typically denoted as body 14. The body 14 serves to
accommodate a drive mechanism having a piston rod to become operably engaged
with a piston of a dge to be ed and fixed in the cartridge holder 12. By
way of the inspection window 24, the fluid or filling level of the cartridge can be
visually inspected.
The known device 10 as illustrated in Figures 1 to 3 is of disposable type. Cartridge
holder 12 and body 14 are adapted to be interconnected in a non-releasable way.
For this purpose, the insert portion 26 of the cartridge holder 12 comprises several
circumferentially buted through openings 28 of substantially rectangular
shape. Correspondingly and as illustrated in Figure 3, the receiving side wall
portion 32 of the body 14 comprises radially inwardly ding pegs or prongs 34
adapted to mate with the h openings 28 of the cartridge holder as soon as
the cartridge holder 12 is appropriately inserted into the body 14 with its insert
portion 26.
Radially inwardly protruding prongs 34 r comprise a bevelled surface 36
towards their distal end in order to facilitate mutual engagement of prongs 34 and
through openings 28. Furthermore, the insert n 26 of the cartridge holder 12
is delimited in distal direction by a circumferential and radially outwardly extending
rim 30, which in a final assembly configuration abuts against a distally located end
face 38 of the body 14.
The housing ents 12, 14 are typically manufactured as ion moulded
plastic components, which, by virtue of appropriately selected thermoplastic
als feature a sufficient elasticity in order to support the snapping in and a
resulting positive onnection of cartridge holder 12 and body 14.
However, since such drug delivery devices 10 are predominately intended for home
medication, the device has to fulfil highest possible standards in terms of failure
safety and robustness, especially in view of mechanical impact.
If for instance the device 10 drops down from a considerably height, a mechanical
load—distribution may rise above a critical level in the interconnection of cartridge
holder 12 and body 14. Point stresses or point loading acting on the through
opening 28 and/or on the prongs 34 may exceed a critical level and the
interconnection of cartridge holder 12 and body 14 may break down, the housing
components 12, 14 may release and the device 1 would be no longer of use.
Objects of the Invention
[t is therefore an object ofthe present invention to provide a drug delivery device
sing a robust, le and mechanically resistant onnection of
cartridge holder and body. The interconnection should be easily integrable in
existing housing designs of drug delivery devices. It should also be easily
implementable, both, in terms of production costs and assembly work. Moreover,
the interconnection of body and cartridge holder should be ive and easy to
establish.
Summary of the Invention
The present invention relates to a drug delivery device for administering a
predefined dose of a medicament. The drug delivery device, typically designed as
pen-type or ses a housing having at least two components, a
ally located body to accommodate a drive mechanism and a distally located
cartridge holder to accommodate a cartridge having a piston ly disposed
therein in an axial ion. The drive mechanism to be arranged in the body
typically has a displaceable piston rod, which is adapted to operably engage with
the piston of the cartridge. This way, the piston rod can exert distally directed thrust
to the piston for expelling a predefined amount of the medicament from the
cartridge via a distally located seal, which is typically to be penetrated by an
injection needle.
dge holder and body are to be directly interconnected by way of an
interconnection. The interconnection is preferably of positive-engaging type and
has at least one displaceable or ently deformable latch element which is
adapted to mate and to engage with a corresponding bearing. The latch element is
displaceable or deformable in a direction (2, w) extending substantially parallel to a
circumferential side wall of body or cartridge holder. Typically, body and cartridge
holder are of substantially cylindrical or tubular shape. The at least one latch
element is therefore adapted to establish a positive interlock between dge
holder and body by way of which a n- or engaging motion can exclusively
take place in the plane defined by the circumferential side walls of body or
cartridge holder.
Such circumferentially directed cement or deformation of the at least one
latch element is beneficial in that mutually corresponding insert portions or
receptacle portions of body and cartridge holder do no longer have to provide a
through opening in a circumferential side wall portion that is to engage with radially
inwardly or outwardly extending prongs or the like. Hence, the circumferential
cement or deformation of the at least one latch element supports a modified
and more robust design of side wall portions of cartridge holder and body.
Consequently, side wall sections of said housing components that form the
interconnection of cartridge holder and body can be designed free of through
openings and/or latch elements.
Also, respective side wall portions of cartridge holder and body can be designed as
substantially closed surfaces inherently providing sed mechanical strength,
reliability and failure safety in the event of considerable mechanical impact.
Preferably, the interconnection is established by a ity of mutually
corresponding and mutually mating latch elements and bearings, that are
preferably ated or integrally formed with said housing components, cartridge
holder and body.
in a preferred embodiment, cartridge holder and/or body, in particular the
interconnection between cartridge holder and body comprise an insert n and
a correSponding receptacle portion for establishing an at least partially interleaved
interconnection of cartridge holder and body. This way, a cartridge holder portion
for instance acting as insert portion can be inserted into a receptacle n of the
body. Respective insert and acle portions then at least partially p in
radial direction when a final assembly configuration is attained.
ably, the cartridge holder comprises the insert portion at a proximal end
section and the body comprises the receptacle portion at a distal end section. This
way, the dge holder can be at least partially inserted into the body in order to
establish a positive interconnection of said housing components. However, the
design of the drug delivery device is not limited to such configurations. It is
generally conceivable, that the cartridge holder comprises a receptacle n
d to receive an insert portion of the body.
According to a further embodiment, the insert portion comprises the at least one
latch element ing in longitudinal direction (2) and having at least one
resiliently deformable spreading piece extending in circumferential direction (w). It
may be of further benefit, when the latch element longitudinally extends from a
distal end of the insert portion. Preferably, a plurality of latch elements is provided
at the distal end face of the insert portion in order to intercept or to distribute
mechanical impact across the circumference of the insert portion.
in a r preferred aspect, the receptacle n comprises the at least one
g, which extends in a lateral plane (x, y) with respect to a tubular shape of
cartridge holder and/or body. Preferably, the bearing extends substantially
perpendicular to the longitudinal extent of body, cartridge holder and/or insert
portion and respective latch elements.
The g is preferably integrally formed with the receptacle portion of the body
and may further t the receptacle portion in proximal direction. Therefore, the
at least one bearing, typically extending radially inwardly from an inside facing side
wall section of the body and/or of its receptacle is preferably integrally formed with
the body. By way of the g extending in the lateral plane, any longitudinally or
axially directed force effect erred via the longitudinally extending latch
element can be transferred to the g and may further conducted and
transferred to the closed shape side wall structure of the body.
in a further preferred aspect, the bearing comprises at least one axial through
opening to receive the at least one latch element of the insert n. Preferably,
the latch element may resiliently deform in order to pass through the bearing's
through g. Thereafter, ferentially extending spreading pieces of the
latch element may appropriately spread, thus preventing to retract the latch
element. The latch element may also comprise an arrow-like , wherein
respective bevelled shaped spreading barbs substantially inhibit a release of the
interconnection of latch element and bearing. in a relaxed configuration, the
through opening of the bearing is therefore smaller than the circumferential extent
of the latch element. The latch element, in particular its spreading pieces or barbs
have to be resiliently squeezed in order to pass through the bearing's through
opening or receptacle.
The through opening of the bearing can be arranged adjacent a circumferential
side wall of the receptacle portion. It may also be arranged at a radial distance
from the side wall portion.
According to another embodiment, the bearing adjacently extends to an inside
facing side wall section of the receptacle portion and further comprises a central
through opening to axially guide a piston rod of the drive mechanism. The central
through opening may be threaded in order to ate with an outer thread of the
piston rod. Alternatively, the central h opening of the g or web may
also se a ly extending groove or protrusion to mate with a radially
ing rotation inhibiting protrusion or groove of the piston rod.
ing to another embodiment, the latch element and the corresponding
bearing are integrated in at least one udinally extending rib and groove of
mutually ng side wall sections of insert portion and receptacle portion of
cartridge holder and body, respectively. When side wall sections of insert portion
and receptacle portion are provided with mutually corresponding ribs and grooves,
a torsion-resistant interconnection of body and cartridge holder can be attained.
Moreover, by way of mutually corresponding tongues and grooves in or on Side
wall ns of body and cartridge holder, a mutual interconnection of said g
components requires a respective rotative alignment of body and cartridge holder
prior to an insertion of insert portion into the receptacle portion. Additional or
adjacent to the above-described latching element, also the groove and the
corresponding rib can be equipped with mutually corresponding latch elements and
gs. For instance, the longitudinal groove may comprise a circumferentially
extending bearing or a respective recess adapted to mate and to engage with
circumferentially extending latch elements of the rib.
Preferably, the rib and/or the groove extend in radial direction with respect to
mutually corresponding side wall sections of insert portion and receptacle portion.
In particular, the rib or a correspondingly shaped tongue may radially outwardly
protrude from a lateral side wall section of the insert n. ingly or
alternatively, the rib may also extend radially inwardly from an inward facing side
wall section of the receptacle portion. A corresponding and ating groove
adapted to receive said rib is provided in the corresponding inner or outer side wall
section of the receptacle or the insert portion.
In a further preferred aspect, the bearing adapted to mate with the at least one
latch element comprises at least one undercutting circumferentially ing in the
groove. The undercutting is designed and configured to cooperate with a spreading
piece or barb of the latch element extending in circumferential direction.
It is of further benefit, when according to another embodiment side wall ns of
the insert portion and/or of the receptacle portion comprise a substantially closed
surface structure, which is substantially free of through gs or comparative
structurally weakened areas. This way, side wall sections of insert portion and
receptacle portion of body and cartridge holder can be structurally strengthened,
such that they become less prone to fracture in response to mechanical impact or
shock.
in a r aspect, the interconnection to be established between cartridge holder
and body is of non-releasable type. Hence, once an interconnection has been
established, a non—destructive release of said housing component is neither
intended nor possible. Upon consumption of the medicament provided in a
cartridge, the drug delivery device is intended to be discarded in its entirety.
According to another preferred aspect, the drug delivery device is equipped with a
lled cartridge ed in the cartridge holder. The cartridge is at least
partially filled with an injectable medicament. Also, the drug delivery device is
further equipped with a drive mechanism arranged in the body, ready to exert
distally directed thrust to the dge's piston for the purpose of ely
expelling a predefined dose or amount of the medicament.
The term medicament“, as used herein, means a pharmaceutical formulation
containing at least one pharmaceutically active compound,
wherein in one embodiment the ceutically active compound has a molecular
weight up to 1500 Da and/or is a peptide, a proteine, a polysaccharide, a vaccine, 3
DNA, a RNA, a antibody, an , an antibody, a hormone or an oligonucleotide, or
a mixture ofthe above-mentioned pharmaceutically active compound,
wherein in a further embodiment the pharmaceutically active nd is useful for the
treatment and/or laxis of diabetes mellitus or cations 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,
sclerosis 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 ated with diabetes us 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-Iike
peptide (GLP-i) or an analogue or derivative thereof, or exedin-S or —4 or an
analogue or derivative of exedin-3 or exedin—4.
Insulin analogues are for example G|y(A21), Arg(B31), Arg(832) human n;
Lys(B3), G|u(829) human insulin; Lys(828), Pro(B.’29) human insulin; Asp(BZ8) human
insulin; human insulin, wherein proline in position 828 is ed by Asp, Lys, Leu, Val
or Ala and wherein in position B29 Lys may be replaced by Pro; Ala(826) human
insulin; Des(828-B30) human insulin; Des(BZ7) human insulin and O) human
insulin.
Insulin derivates are for example B29-N-myristoyl-des(830) human insulin; BZQ-N-
palmitoyI-des(830) human insulin; BZQ-N-myristoyl human insulin; BZQ-N—palmitoyl
human insulin; BZS—N-myristoyl LysB28ProBZQ human insulin; BZS—N-palmitoyl-
LysBZSProBZQ human insulin; BSO-N-myristoyl—ThrBZQLysBBO human insulin; BBO-N-
palmitoyl— ThrBZQLysBSO human insulin; BZQ-N-(N-palmitoyl—Y-glutamyl)—des(B30)
human n; BZQ-N—(N—lithocho|y|-Y-g|utamyl)-des(B30) human insulin; BZQ-N-(w-
carboxyheptadecanoyl)—des(BSO) human n and (w-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~GIu—Ala—VaI—Arg~Leu-Phe-
IIe-Glu-Trp-Leu-Lys-Asn-Gly—GIy—Pro—Ser—Ser-GIy—Ala—Pro-Pro-Pro-Ser—NHZ.
Exendin-4 derivatives are for example selected from the following list of compounds:
H-(Lys)4-des Pr036, des Pr037 Exendin-4(1-39)-NH2,
H-(Lys)5-des Pr036, des Pr037 Exendin-4(1-39)-NH2,
des Pr036 [Asp28] Exendin-4(1-39),
des Pr036 p28] Exendin-4(1-39),
des Pr036 [Met(O)14, Asp28] Exendin-4(‘|-39),
des Pr036 [Met(O)14, |soAsp28] Exendin-4(1-39),
des Pr036 [Trp(02)25, Asp28] Exendin—4(1-39),
des Pr036 [Trp(02)25, |soAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, |soAsp28] n-4(1-39); or
des Pr036 ] Exendin-4(‘l-39),
des Pr036 [|soAsp28] Exendin-4(1-39),
des Pr036 [Met(O)14, Asp28] Exendin-4(1-39),
des Pr036 [Met(O)14, |soAsp28] Exendin-4(1-39),
des Pr036 [Trp(02)25, Asp28] Exendin-4(1—39),
des Pr036 2)25, 28] Exendin-4(1-39),
des Pro36 [Met(O)14 Trp(02)25, Asp28] Exendin-4(1-39),
des Pr036 [Met(O)14 Trp(02)25, lsoAsp28] Exendin-4(1—39),
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
H-(Lys)6—des Pr036 [Asp28] Exendin-4(1-39)-Ly36-NH2,
des Asp28 Pr036, Pr037, Pro38Exendin—4(1-39)—NH2,
H-(Lys)6-des Pro36, Pr038 [Asp28] Exendin—4(1—39)—NH2,
H-Asn-(Glu)5des Pr036, Pro37, Pr038 ] Exendin-4(1—39)—NH2,
des Pr036, Pr037, Pr038 [Asp28] n—4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pro36, Pr037, Pr038 [Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5-des Pr036, Pr037, Pr038 [Asp28] Exendin-4(1-39)—(Lys)6-NH2,
H-(Lys)6-des Pro36 [Trp(02)25, Asp28] Exendin-4(1-39)—Ly56-NH2,
H-des Asp28 Pr036, Pro37, Pr038 02)25] Exendin-4(1—39)—NH2,
H-(Lys)6-des Pr036, Pr037, Pro38 [Trp(02)25, Asp28] Exendin-4(1—39)-NH2,
H-Asn—(Glu)5-des Pr036, Pr037, Pr038 2)25, Asp28] n-4(1-39)-NH2,
des Pro36, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6—NH2,
)6-des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5~des Pr036, Pr037, Pr038 [Trp(02)25, Asp28] Exendin-4(1-39)—(Lys)6~
NH2,
H-(Lys)6-des Pr036 [Met(O)14, Asp28] Exendin-4(1—39)—Ly86—NH2,
des Met(O)14 Asp28 Pr036, Pro37, Pr038 Exendin-4(1-39)-NH2,
H—(Lys)6—desPr036, Pr037, Pr038 [Met(O)’l4, Asp28] Exendin-4(1-39)-NH2,
H—Asn-(GIu)5—des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1-39)—NH2,
des Pr036, Pr037, Pro38 [Met(O)14, Asp28] n-4(1-39)-(Lys)6-NH2,
H-(Lys)6-des Pr036, Pr037, Pr038 [Met(O)14, Asp28] n-4(1-39)-(Lys)6-NH2,
H-Asn-(Glu)5 des Pr036, Pr037, Pro38 [Met(O)14, Asp28] Exendin~4(‘l-39)-(Lys)6-NH2
H-LysG-des Pro36 [Met(O)14, Trp(02)25, Asp28] Exendin-4(1-39)-Ly36-NH2,
H—des Asp28 Pr036, Pr037, Pr038 [Met(O)14, Trp(02)25] Exendin-4(1-39)—NH2,
H—(Lys)6—des Pr036, Pr037, Pr038 [Met(O)14, Asp28] Exendin-4(1-39)-NH2,
H-Asn-(GIu)5-des Pr036, Pro37, Pro38 [Met(O)14, Trp(02)25, Asp28] Exendin—4(1-39)-
NH2,
des Pro36, Pr037, Pr038 [Met(O)14, Trp(02)25, Asp28] Exendin-4(1-39)—(Lys)6-NH2,
H-(Lys)6-des Pr036, Pro37, Pro38 [Met(O)14, )25, Asp28] Exendin-4(S1-39)-
(Lys)6-NH2,
H—Asn—(Glu)5-des Pr036, Pr037, Pr038 [Met(O)i4, Trp(O2)25, Asp28] Exendin-4(1-39)—
-NH2;
or a pharmaceutically acceptable salt or solvate of any one of the afore-mentioned
Exedin—4 derivative.
es 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 glucosaminoglycane, a hyaluronic acid, a heparin, a
low molecular weight heparin or an ultra low lar weight heparin or a derivative
thereof, or a ted, e.g. a poly-sulphated form of the above—mentioned
polysaccharides, and/or a pharmaceutically acceptable salt thereof. An example of a
ceutically acceptable salt of a ulphated low molecular weight heparin is
enoxaparin sodium.
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: en,
an optionally substituted Ct-CG-alkyl group, an optionally substituted alkenyl
group, an optionally substituted CB-C10-aryl group, or an optionally substituted CS-CiO-
heteroaryl group. Further es of pharmaceutically acceptable salts are described
in "Remington's Pharmaceutical Sciences" 17. ed. Alfonso R. Gennaro (Ed.), Mark
Publishing Company, Easton, Pa, , 1985 and in Encyclopedia of Pharmaceutical
Technology.
Pharmaceutically acceptable solvates are for example hydrates.
It will be further nt to those skilled in the ent art that various
modifications and variations can be made to the present invention without
ing from the spirit and scope of the ion. r, it is to be noted, that
any reference signs used in the appended claims are not to be construed as
limiting the scope of the present invention.
Brief Description of the Drawings
In the following, preferred embodiments of the invention will be described by
making reference to the drawings, in which:
Figure 1 schematically illustrates a drug delivery device according to the
prior art in an exploded view,
Figure 2 separately illustrates a cartridge holder shown in Figure 1, and
Figure 3 schematically depicts a cross section through the body
component according to Figure 1,
Figure 4 is illustrative of the interconnection of body and cartridge holder
according to a first embodiment of the invention,
Figure 5 schematically shows an alternative design for a latch element,
Figure 6 schematically depicts a latch element integrated in a longitudinal
rib of the dge holder, and
Figure 7 schematically shows a positive interlock attainable by way of a
latch element according to Figure 6.
Detailed Description
In Figure 4, a receptacle portion 51 of a body housing component 50 is rated,
which is adapted to receive a correspondingly shaped insert portion 66 of a
dge holder 60. In contrast to the embodiment as illustrated in Figures 1 to 3,
the side wall sections 52, 65 of body 50 and cartridge holder 60 substantially
comprise an entirely closed surface structure, which is free of radial through
openings.
The latch mechanism 59 attainable by the embodiment as illustrated in Figure 4 is
based on arrow-like latch elements 68 extending in longitudinal direction (2) from a
proximal end of the insert portion 66. The body 50 comprises a tubular or
rically shaped side wall 52 having a bearing 54 extending in a lateral plane
(x, y). The bearing 54, which also serves as a lateral web is ally formed with
the lateral side wall 52 of the body 50 and comprises at least one axial through
opening 58 which is adapted to receive and to mate with the longitudinally
extending latch elements 68 of the insert n 66.
The latch elements 68 as illustrated in Figure 4 comprise two oppositely and
circumferentially extending spreading pieces or barbs 70 that may squeeze or
circumferentially deform when urged through the through gs 58 of the
bearing 54. Resilient or elastic deformation of the barbs 70 can be supported by a
longitudinal slit 72 extending between the ferentially extending spreading
pieces 70.
Position and circumferential distribution of the latch elements 68 corresponds with
the circumferential size and on of the axial through gs 58 of the bearing
54. The bearing 54 as further illustrated in Figure 4 also comprises a central and
threaded through g 56, that serves to axially guide a piston rod of a drive
mechanism being not further illustrated here.
The latch elements 68 as shown in Fig. 4 extend in longitudinal direction (2) as well
as in circumferential direction (w). They are particularly adapted to resiliently or
elastically deform in circumferential direction (w) in order to establish a positive
interlock with the bearing 54. This way, a mutual interconnection of body 50 and
cartridge holder 60 can be ed on the basis of a positive snap~ln solution
without the necessity to provide through openings or other structurally weakened
portions in the side wall sections 52, 65 of receptacle n 51 and insert portion
Typically, the longitudinal extension of the insert portion 66 substantially matches
with the longitudinal extension of the receptacle portion 51. When a final assembly
configuration of the drug delivery device is ed, cartridge holder 60 and body
50 not only abut in radial direction but also in longitudinal direction (2). it is
intended, that a distal and lower end face of the body abuts 50 in longitudinal
direction with a radially extending circumferential rim 64 of the cartridge holder 60.
Correspondingly, also a ally located end face of the insert n 66 may
but against the transverse or laterally extending bearing 54 in final assembly
configuration. The circumferential rim 64 further separates a distal and
substantially r shaped portion 62 of the cartridge holder 12 and the insert
portion 66.
Figure 5 shows an alternative embodiment of a latch element 74 comprising a
somewhat arrow-like shape and having two bevelled barbs 78 at the free end of an
elongated socket n 76. The barbs 78 are intended to mate and to abut with
the proximally d surface of the bearing 54 as illustrated in Figure 4.
The embodiment according to Figures 6 and 7 is rative of another snap—in
configuration. Here, the insert portion 66 of the cartridge holder 60 comprises
substantially longitudinally extending ribs or tongues 80 with circumferentially
extending latch elements 82 comprising circumferentially extending barbs 84
that mate with correspondingly shaped recesses 88 of a longitudinal groove
86 ed in the inside facing side wall n 52 of the receptacle 51 of
the body component 50.
Here, it is of further benefit, when the circumferentially protruding barbs or
spreading pieces 84 comprise a ient elasticity that allows to urge the
latch elements 82 through the groove 86 in longitudinal direction (2) until a
final assembly configuration as illustrated in Figure 7 is reached. The recess
88 which is adapted to odate a relaxed latch t 82 comprises
an undercutting 90 substantially extending in the lateral plane (2, w).
However, also other ments are conceivable, wherein the undercutting
90 and the circumferentially protruding barbs comprise mutually
corresponding abutment faces extending at an angle, substantially smaller
than 90° with respect to the direction of assembly (2).
The embodiment ing to Figures 6 and 7 can be arbitrarily combined
with the embodiment according to Figure 4 and may therefore provide an
additional fixation of cartridge holder 60 and body 50 of a drug delivery
, e.g. of pen—injector type.
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.
List of Reference ls
drug delivery device
12 cartridge holder
14 body
16 threaded socket
18 needle assembly
needle holder socket
22 injection needle
24 inspection window
26 insert portion
28 through opening
rim
32 receptacle
34 prong
36 bevelled surface
38 end face
50 body
51 receptacle portion
52 side wall
54 beanng
56 through opening
58 through opening
59 onnection
6O cartridge holder
62 distal portion
64 rim
65 side wall
66 insert portion
68 latch element
70 barb
72 slit
74 latch element
76 socket
78 barb
80 rib
82 latch t
84 barb
86 groove
88 receptacle
90 undercutting
Claims (1)
1. A drug delivery device for administering a ined dose of a medicament comprising a housing : — a body to accommodate a drive mechanism, - a cartridge holder to accommodate a cartridge having a piston slidably disposed therein in an axial direction (2), - an interconnection between cartridge holder and body, said interconnection having at least one displaceable or resiliently deformable latch element to mate with a ponding bearing, n the latch element is displaceable or deformable in a direction (2, w) extending substantially parallel to a circumferential side wall of the body or cartridge holder, wherein dge holder and body comprise an insert portion and a corresponding receptacle portion for establishing an at least partially interleaved interconnection of cartridge holder and body, characterized in that - the receptacle portion comprises the at least one bearing extending in a lateral plane (x, y) with respect to a tubular shape of cartridge holder and/or body and ing radially ly from an inside facing side wall section of the receptacle, and n — the bearing comprises at least one axial through opening to receive the latch element. The drug delivery device according to claim 1, wherein the cartridge holder comprises the insert portion to be inserted into the receptacle portion of the body, or vice versa. The drug delivery device according to any one of the preceding claims 1 or 2, wherein the insert portion comprises the at least one latch element extending in longitudinal direction (2) and having at least one resiliently deformable spreading piece ing in circumferential direction (w). The drug delivery device according to any one of the preceding claims, n the bearing adjacently s to an inside facing side wall n of the receptacle portion and comprises a central through opening to axially guide a piston rod of the drive mechanism. The drug delivery device according to any one of the preceding claims, wherein side wall sections of the insert n and/or of the receptacle portion comprise a closed surface structure, free of through openings. The drug delivery device according to any one of the ing claims, wherein the interconnection is of non—releasable type. The drug delivery device according to any one of the preceding claims, further comprising a cartridge filled with a medicament disposed in the cartridge . A drug delivery device substantially as herein described with reference to any embodiment shown in figures 4 to 7 of the accompanying drawings. WO 71981
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP11170308.8 | 2011-06-17 | ||
EP11170308 | 2011-06-17 | ||
PCT/EP2012/061249 WO2012171981A1 (en) | 2011-06-17 | 2012-06-14 | Cartridge holder assembly for drug delivery devices |
Publications (2)
Publication Number | Publication Date |
---|---|
NZ619087A NZ619087A (en) | 2015-04-24 |
NZ619087B2 true NZ619087B2 (en) | 2015-07-28 |
Family
ID=
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