Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
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Disposable injector with two-stage trigger
Description:
The invention relates to a disposable injector having a housing
and having a trigger device comprising an energy store, an
actuating plunger and a trigger sleeve.
A disposable injector is known from the postpublished DE 10 2007
031 630 Al. The trigger mechanism is subjected to load by means
of is throughout the storage time. The two-stage triggering can
be realized without changing the grip position on the disposable
injector.
The challenge of the present invention is to develop a disposable
injector which affords secure triggering even after a long
storage period. Moreover, the user is intended to deliberately
unlock the disposable injector prior to the triggering.
To this end, the actuating plunger and the housing have mutually
facing blocking surfaces, between which at least one displacement
body can be disposed. The actuating element is pivotable about
the longitudinal axis of the disposable injector and comprises
displacer segments arranged offset from the blocking surfaces, so
that the displacer segments can be brought into contact with the
displacement body. Moreover, by means of a shifting of the
trigger sleeve in the direction of the longitudinal axis, a
travel limitation of the displacer body subjected to load by
means of the displacer segment can be lifted for the release of
the energy store.
In some embodiments disclosed herein, there is provided a
disposable injector having a housing and having a trigger device
comprising a mechanical energy store, an actuating plunger and a
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trigger sleeve, wherein the actuating plunger and the housing
have mutually facing blocking surfaces, between which at least
one displacement body can be disposed, wherein the actuating
plunger is pivotable about the longitudinal axis of the
disposable injector and comprises displacer segments arranged
offset from the blocking surfaces, so that the displacer segments
can be brought into contact with the displacement body, wherein,
by means of a shifting of the trigger sleeve in the direction of
the longitudinal axis, a travel limitation of the displacer body
subjected to load by means of the displacer segment can be lifted
for the release of the energy store, and further comprising an
adapter assembly, positively connected to the actuating plunger,
for receiving a cylinder piston unit, and wherein the adapter
assembly is pivotable relative to the housing.
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Figure 1: Disposable injector in the storage state;
figure 2: Section of the housing at the level of the
apertures;
figure 3: Side view of the actuating element;
figure 4: View of the actuating element from below;
figure 5: Top view of the adapter sleeve;
figure 6: Detail of the disposable injector from fig.
1;
figure 7: Detail from figure 6;
figure 8: Detail of the disposable injector following
pivoting of the actuating element;
figure 9: Detail of the disposable injector following
actuation of the trigger element;
figure 10: Detail of the disposable injector with
displaced displacement body;
figure 11: Detail of the triggered disposable
injector;
figure 12: Detail of the trigger device having a
broadly cuboid displacement body.
Figures 1 - 11 show a disposable injector (4).
Disposable injectors (4) of this type are used for the
one-off introduction into the human body of a defined
dose, for instance, of a solution containing an active
substance. The solution (1) which is to be introduced
through the skin, for example, is stored in a cylinder-
piston unit (100). Following triggering of the
disposable injector (4), the piston (111) of this
cylinder-piston unit (100) is shifted in the direction
of the discharge opening (127) and hereupon displaces
the liquid drug solution (1) through a needle, or
without a needle, under the skin.
The disposable injector (4) comprises a housing (10)
and a trigger device (80). The housing (10) is of bell-
like construction. On the inner side of the user-facing
base (39), an energy store (50) is supported, for
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example by means of a spacer washer (19). In the
illustrative embodiment, the energy store (SO) is a
spring element, for example a compression spring (50).
The use of a pyrotechnic energy store (50) is also
conceivable. The housing (10) produced from an
austenitic steel material or from plastic has a stepped
wall (11), which widens toward an opening (38) remote
from the base (39), cf. figure 6. This opening (38) is
surrounded by an outer annular flange (12). The plane
of the annular flange (12) is arranged perpendicular to
the longitudinal direction (5) of the disposable
injector (4). The width of the annular flange (12) in
the radial direction is greater than or equal to the
wall thickness of the housing (10).
In the lower shell region (14), the housing (10) has,
for instance, four apertures (15) evenly distributed on
the periphery. These apertures (15) have, for example,
a broadly square cross section, wherein the corners can
20 be rounded. The housing (10) can also have one, two or
three apertures (15).
Figure 2 shows a cross section of the housing (10) with
direction of view onto the annular flange (12), wherein
25 the sectional plane intersects the apertures (15). On
the bottom edges of the apertures (15), supporting
elements (16) are bent inward. These are configured,
for instance, in the shape of a circular segment. Those
surfaces (17) of the supporting elements (16) which in
figure 2 are facing the observer are hereinafter
referred to as the blocking surfaces (17). These can
lie in a plane perpendicular to the longitudinal
direction (5). They can also however form with this
plane - as represented in figure 7 - an angle up to 10
degrees. The inner ends of the blocking surfaces (17)
are here arranged closer to the opening (38) than are
the outer ends.
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In the housing (10) is arranged the actuating part
(60). This is represented in a side view in figure 3
and in a view from below in figure 4. The actuating
part (60) comprises a guide ring (62), a plunger (71)
and a piston actuating rod (66).
The centering ring (62) seated on the plunger (71)
encompasses and, in the illustrative embodiment, guides
the spring (50) on its outer side. An inner centering
and guidance of the spring (50) is also conceivable.
The diameter of the disk-like plunger (71) is, for
instance, two-tenths of a millimeter smaller than the
internal diameter of the housing (10). The plunger (71)
is oriented, for example, perpendicular to the
longitudinal direction (5) of the disposable injector
(4).
In the illustrative embodiment, the bottom side of the
actuating plunger (60), which bottom side is arranged
opposite to the centering ring (62), has four blocking
surfaces (72) and four displacer segments (73) arranged
offset from these same. In the representations of
figures 1, 3, 6 and 7, the blocking surfaces (72) are
surface portions arranged in a plane perpendicular to
the longitudinal axis (5). The displacer segments (73),
which are arranged, for instance, relative to the
longitudinal axis (5), respectively offset by an angle
of 45 degrees hereto, respectively have a recess (74),
which continues in the shell surface (75) of the
centering ring (62). Each of the cylinder-segment-
shaped recesses (74) projected into the plane of the
blocking surfaces (72) has in this plane an area which
is congruent to the blocking surface (17) of the
housing (10), which blocking surface is projected into
the same plane. The projected area of a recess (74) can
also be greater than the projected blocking surface
(17) of the housing (10). The individual recess (74)
can also be a segment of the plunger (71). The
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individual displacer segment (73) can comprise an
inclined plane. The blocking surfaces (72) and the
displacement segments (73) are inwardly limited by a
limiting ring (76). This has a cylindrical shell
surface (77),
The piston actuating rod (66), the so-called piston
slide valve (66), is arranged opposite to the guide
ring (62) centrically on the plunger (71). In the
installed state, its projecting end (67) penetrates the
opening (38) of the housing (10). In the illustrative
embodiment, the piston slide valve (66) has a constant,
square cross section. It is also conceivable, however,
to configure the piston slide valve (66) with a
triangular, hexagonal, polygonal, etc. cross section.
In the installed state, of. figure 1, the free end (67)
is immersed in the cylinder (101) and ends just a few
millimeters above the piston (111). The diagonal of the
cross-sectional area of the piston slide valve (66) is
smaller than the internal diameter of the cylinder
(101). The actuating rod (66) can thus be guidable in
the cylinder (101).
In the representation of figure 1, between the blocking
surfaces (17, 72) of the housing (10) and of the
actuating part (60) are arranged displacement bodies
(86). In the represented illustrative embodiment, these
are balls (86), which are supported on both blocking
surfaces (17, 72). In the illustrative embodiment, the
two contact points are arranged one above the other.
Where necessary, the trigger sleeve (90), which closes
off the apertures (15), also prevents excursion of the
balls (86). In the case of a housing blocking surface
(17) which rises from inside to out, the balls (86) are
subjected to load inward in the direction of the
limiting ring (76). The radius of the displacement
bodies (86) can be smaller than or equal to the
imaginary radius of the recesses (74).
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The displacement bodies (86) can also be of broadly
wedge-shaped or cuboid configuration in cross section.
A body of this type is represented, for instance, in
figure 12. It comprises two locking surfaces (87, 88)
arranged, for example, parallel to each other.
Inwardly, the upper locking surface (87) adjoins a
displacer surface (89). The latter forms with a
straight line parallel to the longitudinal direction
(5), for instance, an angle less than or equal to 45
degrees.
The annular flange (12) of the housing (10) is held in
an adapter assembly (130), cf. figures 6 and 7. This
adapter assembly (130) comprises an adapter sleeve
(131) and an adapter ring (151). Both parts are made,
for instance, of a thermoplastic plastic.
The adapter sleeve (131) has a broadly pot-shaped form.
At its end facing away from the energy store (50), it
has, for example, expandable undercut elements (132),
which, in the mounted state, hold the cylinder-piston
unit (100). At its end facing toward the energy store
(50), the adapter sleeve (131) has a back-up ring (133)
having a flat top side. The shell surface (134) of the
back-up ring (133) has an external thread (135). In the
representation of figure 7, a flat (136) for the
application of an assembly tool is arranged beneath
this thread (135).
Figure 5 shows a top view of the adapter sleeve (131).
The upwardly directed circular base plate (137) has in
this representation a square aperture (138). Through
this aperture (138) is guided, in the mounted state,
the piston actuating rod (66). The clearance of the
actuating rod (66) in the aperture (138) is, for
instance, less than two-tenths of a millimeter. The top
side of the back-up ring (133) comprises an outer
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pressing surface (139) and an inner sliding surface
(141) which is concentric thereto and adjoins the same.
The adapter ring (151) has a circular aperture (152).
The diameter of the aperture (152) is greater than the
outer diameter of the housing (10) and less than the
outer diameter of the annular flange (12). The bottom
side of the adapter ring (151) comprises an axial (153)
and a radial sliding surface (154), which, in the
mounted state, together with the sliding surface (141)
of the adapter sleeve (131), surround the annular
flange (12) of the housing (10). The radial and the
axial clearance of the slide bearing (145) respectively
amount to, for instance, one-tenth of a millimeter.
Outside the sliding surface (153) of the adapter ring
(151) is arranged a pressing ring (155). In the
installed state, this contacts the pressing surface
(139) of the adapter sleeve (131). Outside the pressing
ring (155), a fastening ring (156) protrudes on the
bottom side of the adapter ring (151). This fastening
ring has an internal thread (157) complementary to the
external thread (135) of the adapter sleeve (131) and,
on its shell surface (158), flats (159). In the
assembly operation, the adapter sleeve (131) and the
adapter ring (151) can thus be mounted with pretension.
The trigger sleeve (90) is of annular construction. It
encompasses the housing (10) and is guided on the same.
The total guide length can be greater than or equal to
double the housing diameter. In the illustrative
embodiment, the trigger sleeve (90) is made of a two-
component material. In the representations of figures 1
and 6, it has a bottom guide and locking ring (91) and
a wall region (99), which are made of a deformation-
resistant material. A top sealing lip (92) is made, for
instance, of an elastically deformable material. Both
materials can be thermoplastic plastics.
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Between the sealing lip (92) and the guide and locking
ring (91) is arranged a receiving chamber (95), which
is limited by means of the wall region (99). The extent
of the receiving chamber (95) in the radial direction
is in the mounted state greater than the diameter of a
displacement body (86). In the case of a non-spherical
displacement body (86), the radial length of the
receiving chamber (95) is greater than the maximum
extent of the displacement body (86) in this direction.
In the representations of figures 1, 6 and 7, the guide
and locking ring (91) has a bottom guide portion (93)
having two single-valued slide bearings (94), and a
locking portion (96) arranged above said guide portion.
The locking portion (96) has a cylindrical inner wall
and merges in a transition radius (97) into the bottom
surface (98) of the receiving chamber (95).
Where necessary, the trigger sleeve (90), in the
mounted state, can be spring-loaded or be prevented
from slippage by means of a band.
In the assembly of the disposable injector (4), the
energy store (50) and the actuating plunger (60), for
instance, are firstly inserted into the housing (10).
The cavities (74) of the actuating part (60) are here
guided along the supporting elements (16) of the
housing (10). The adapter ring (151) is now placed from
above onto the housing (10). From the bottom, the
adapter sleeve (131) is slipped onto the actuating part
(60). When the threads (135, 157) of the adapter ring
(151) and of the adapter sleeve (131) are screwed
together, the pressing ring (155) and the pressing
surface (139) are subjected to load. Thus, in
dependence on the pretension of the screw connection,
the clearance of the slide bearing (145) can be
adjusted and the screw connection can be secured
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against loosening. The trigger sleeve (90) is slipped
onto the housing (10) from above.
The actuating part (60) can now be slid in from its
free end (67) relative to the housing (10) and to the
adapter assembly (130), so that the spring (50) is
compressed. The energy store is hereupon loaded. The
adapter assembly (130) can now be pivoted, for example,
through an angle of 45 degrees relative to the housing
(10). In this course of this pivoting, the adapter
sleeve (131), by means of the form closure between the
aperture (138) and the piston slide valve (66), takes
the actuating part (60) along with it. The blocking
surfaces (72) of the actuating part (60) now stand
above the blocking surfaces (17) of the housing (10).
After the component parts have been secured in this
position, the displacement bodies (86) are inserted. To
this end, the trigger sleeve (90) is pushed downward,
for instance, in the triggering direction (6). After
the sealing lip (92) has been bent up, the balls (86)
can be fed into the now open receiving chamber (95).
Through the apertures (15), the displacement bodies
(86) are then inserted between the blocking surfaces
(17, 72). The temporary assembly securement of the
actuating part (60) and of the spring (50) can now be
undone. The spring-loaded plunger (71) now presses the
balls (86) against the blocking surfaces (17) of the
housing (10). The disposable injector (4) is locked.
The trigger sleeve (90) can be pushed upward again and
is secured, for example, by means of a tamper-evident
closure.
The filled cylinder-piston unit (100) is inserted into
the adapter sleeve (131) and non-releasably latched,
for instance.
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The disposable injector (4) - with or without built-in
cylinder-piston unit (100) - can be stored for several
months or years,
In order to use the disposable injector (4), the doctor
or patient holds the injector (4) with two hands and
twists the adapter assembly (130) relative to the
housing (10). With the pivoting of the adapter assembly
(130), the actuating plunger (60) is transported via
the positive connection (66, 138). The housing (10)
pivots relative to the adapter assembly (130) in the
slide bearing (145). The apertures (15) and/or the form
of the supporting elements (16) prevent excursion of
the balls (86). The displacer segments (73) come into
contact with the displacer bodies (86), cf. figure 8.
The spring (50) is hereupon slackened by just a few
tenths of a millimeter, so that the disposable injector
(4) latches in this position. A further pivoting of the
adapter assembly (130) and of the actuating plunger
(60) is not possible.
The force application to the ball (86) has relocated
inward, so that the ball (86) is displaced outward in
the direction of the locking portion (96) of the
trigger sleeve (90). The ball (86) abuts against the
locking portion (96), which prevents further
displacement of the ball (86). The first securement of
the two-stage trigger mechanism is herewith lifted.
After the disposable injector (4) has been applied to
the skin of the patient, the injector (4) can be
triggered. To this end, the trigger sleeve (90) is
pushed in the triggering direction (6), in the
representation of figure 1 downward. The travel
limitation of the displacement body (86) is lifted, cf.
figure 9. The state represented in figure 9 is not
stable, for, after the locking mechanism has been
lifted, the discharging energy store (50), by means of
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the plunger (71), displaces the ball (86) outward into
the receiving chamber (95), cf. figure 10.
The accelerated actuating part (60) strikes with the
actuating rod (66) the piston (111) of the cylinder-
piston unit (100). The piston (111) which has been
shifted in the direction of the discharge opening (127)
displaces the stored drug solution (1) through the
discharge opening (127) into the skin of the patient.
The actuating plunger (60) here travels relative to the
displacement body (86) situated in the housing (10)
and/or in the receiving chamber (95). Where necessary,
the displacement body (86) can also jut into the
cavities (74) of the plunger (71).
As soon as the piston (111) and the actuating part (60)
stand in the front end position, the ball (86) can be
situated above the guide ring (62). If the trigger
sleeve (90) is now pulled hack upward, the ball (86)
can be displaced into the housing (10), for example by
means of a sloping bottom surface (98). The
displacement body (86) can then block renewed insertion
of the actuating element (60) into the housing (10).
Reuse of the disposable injector (4) is thus
effectively prevented.
Of course, it is also conceivable to combine the
various stated embodiments one with another,
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Reference symbol list:
1 Drug solution
4 Disposable injector, single-use injector
5 Center line of the injector, longitudinal
direction
6 Direction arrow for triggering motion direction,
downward motion
10 housing
11 wall
12 annular flange
14 shell region
15 apertures
16 supporting elements
17 surfaces, blocking surfaces
19 spacer washer
38 opening
39 base
50 energy store, spring element, compression spring
60 actuating part, actuating plunger, actuating
element
62 guide ring, centering ring, guide element for (50)
66 piston actuating rod, piston slide valve
67 projecting end of (66), free end of (66)
71 plunger
72 blocking surfaces
73 displacer segments
74 recesses, cavities
75 shell surface of (71)
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76 limiting ring
77 shell surface of (76)
80 trigger device
86 displacement bodies, balls
87 locking surface
88 locking surface
89 displacer surface
90 trigger sleeve
91 guide and snap ring
92 sealing lip
93 guide portion
94 slide bearing
95 receiving chamber
96 locking portion
97 transition radius
98 bottom surface
99 wall region
100 cylinder-piston unit
101 cylinder
111 piston
127 discharge opening
130 adapter assembly
131 adapter sleeve
132 undercut elements
133 back-up ring
134 shell surface
135 external thread
136 flat
137 circular base plate
138 aperture
139 pressing surface
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141 sliding surface
145 slide bearing
151 adapter ring
152 aperture
153 axial sliding surface
154 radial sliding surface
155 pressing ring
156 fastening ring
157 internal thread
158 shell surface
159 flats
