U.S. patent application number 11/948014 was filed with the patent office on 2008-03-20 for injection apparatus comprising a needle-protecting device.
This patent application is currently assigned to TecPharma Licensing AG. Invention is credited to Edgar Hommann, Benjamin Scherer.
Application Number | 20080071225 11/948014 |
Document ID | / |
Family ID | 32331828 |
Filed Date | 2008-03-20 |
United States Patent
Application |
20080071225 |
Kind Code |
A1 |
Hommann; Edgar ; et
al. |
March 20, 2008 |
INJECTION APPARATUS COMPRISING A NEEDLE-PROTECTING DEVICE
Abstract
An injection device including a receptacle for an active
substance, which is connected to an injection needle and is
accommodated inside a sliding sleeve that can be displaced within a
housing by a driving force. A sleeve-shaped needle-protecting
device is displaceable within the housing by a spring such that the
needle-protecting device moves forward and extends past the
injection needle in an axial direction when the injection needle is
withdrawn from the body tissue. A lock prevents the
needle-protecting device from being manually pushed backward, the
lock effective between the needle-protective device and the sliding
sleeve, and being automatically deactivated when the sliding sleeve
is at least approximately back in its retracted position.
Inventors: |
Hommann; Edgar;
(Grossaffoltern, CH) ; Scherer; Benjamin; (Uster,
CH) |
Correspondence
Address: |
DORSEY & WHITNEY LLP;INTELLECTUAL PROPERTY DEPARTMENT
SUITE 1500
50 SOUTH SIXTH STREET
MINNEAPOLIS
MN
55402-1498
US
|
Assignee: |
TecPharma Licensing AG
|
Family ID: |
32331828 |
Appl. No.: |
11/948014 |
Filed: |
November 30, 2007 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11135602 |
May 23, 2005 |
|
|
|
11948014 |
Nov 30, 2007 |
|
|
|
PCT/CH03/00757 |
Nov 17, 2003 |
|
|
|
11135602 |
May 23, 2005 |
|
|
|
Current U.S.
Class: |
604/198 ;
604/194; 604/526 |
Current CPC
Class: |
A61M 5/2033 20130101;
A61M 2005/206 20130101; A61M 5/326 20130101; A61M 2005/2073
20130101; A61M 2005/3247 20130101; A61M 5/3202 20130101 |
Class at
Publication: |
604/198 ;
604/194; 604/526 |
International
Class: |
A61M 5/32 20060101
A61M005/32; A61M 25/00 20060101 A61M025/00 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 25, 2002 |
CH |
1986/02 |
Claims
1. A device for injecting an active substance, comprising an
injection needle, a housing, a receptacle for the active substance,
a syringe piston displaceable in the receptacle for the purpose of
expelling the active substance, and a needle protecting device
displaceable relative to the housing, wherein, during a skin
penetration of the injection needle, the needle protecting device
remains in a substantially constant position relative to the
housing and in the process a spring element is stressed, wherein,
after the removal of the injection needle from the skin, the spring
element pushes the needle protecting device into an advanced
position in which the needle is covered.
2. The device according to claim 1, wherein the receptacle is
accommodated in a sliding sleeve, which during the skin penetration
is displaced within the housing from a retracted position to an
advanced position.
3. The device according to claim 2, wherein the needle protecting
device is automatically locked in its advanced position by locking
means, which locking means are operative between the needle
protecting device and the sliding sleeve when the needle protecting
device and the sliding sleeve are located in their advanced
position.
4. The device according to claim 3, wherein further comprising
means for releasing the locking means which means for releasing are
operative when the sliding sleeve is located at least approximately
in its retracted position.
5. The device according to claim 4, wherein the means for releasing
the locking display a projection arranged in the housing and
jutting inward, which projection in the retracted position of the
sliding sleeve presses the flexible tongue radially inward in such
a way that part of the sliding sleeve containing the flexible
tongue can move into the region of the needle protecting
device.
6. The device according to claim 2, wherein the spring element
presses the needle protecting device into its advanced position and
which is stressed by the sliding sleeve when the latter moves into
its advanced position.
7. The device according to claim 2, further comprising carrier
means to cause the needle protecting device to be carried along by
the sliding sleeve when the sliding sleeve is guided from its
advanced position into its retracted position.
8. The device according to claims 7, further comprising a restoring
spring element which acts on the sliding sleeve in the direction of
the retracted position of the sliding sleeve.
9. An injection device comprising: a container for an active
substance, said container connected to an injection needle and
accommodated inside a sliding sleeve that can be displaced within a
housing by means of a driving force; a generally sleeve-shaped
needle-protecting device displaceable within the housing by means
of a spring such that said needle-protecting device extends past
the injection needle in an axial direction when the injection
needle is withdrawn from the body tissue; and a lock that prevents
the needle-protecting device from being manually moved to uncover
the needle when the lock is engaged, the lock operably effective
between the needle-protective device and the sliding sleeve, and
being automatically deactivated when the sliding sleeve is at least
approximately in a retracted position.
10. A device for injecting an active substance comprising: an
injection needle; a housing; a receptacle for the active substance
accommodated substantially in a moveable sleeve which is moveable
relative to the housing; and a needle protector moveable relative
to the housing, wherein, during an injection, the needle protector
remains in a substantially constant position relative to the
housing and in the process a spring element is stressed, and
wherein, after the injection, the spring element urges the needle
protector into an advanced position in which the needle is covered
and the needle protector is prevented from moving from the advanced
position by the moveable sleeve.
11. The device according to claim 10, wherein during an injection,
the moveable sleeve is moved within the housing from a retracted
position to an advanced position and the needle protector is
automatically locked in the advanced position by a lock operative
between the needle protector and the moveable sleeve when the
needle protector and the moveable sleeve are located in their
advanced position.
12. The device according to claim 11, further comprising a release
for the lock, said release operable when the moveable sleeve is
located at least approximately in the retracted position.
13. The device according to claim 12, wherein the release comprises
a step associated with the housing and jutting inward, wherein,
when the moveable sleeve is in the retracted position, the step
presses the tongue radially inwardly such the moveable sleeve can
move relative to the needle protector.
14. The device according to claim 10, wherein the spring element
presses the needle protector into its advanced position and is
stressed by the moveable sleeve when the moveable sleeve moves into
its advanced position.
15. The device according to claim 10, further comprising carriers
operably coupling the needle protector and the moveable sleeve and
causing the needle protector to be moved by the moveable sleeve
when the moveable sleeve moves from its advanced position to its
retracted position.
16. The device according to claim 15, further comprising a
restoring spring acting on the moveable sleeve in the direction of
the retracted position of the moveable sleeve.
Description
CROSS-REFERENCE TO RELATED APPLICATION(S)
[0001] This application is a continuation of U.S. application Ser.
No. 11/135,602, filed on May 23, 2005, which is a continuation of
International Application No. PCT/CH2003/000757, filed on Nov. 17,
2003, which claims priority to Swiss Application No. 1986/02, filed
on Nov. 25, 2002, the contents of which are incorporated in their
entirety by reference herein.
BACKGROUND
[0002] The application relates to devices and methods for
delivering, administering, dispensing or injection a substance.
More particularly, it relates to an apparatus for injecting an
active substance having an injection needle, a housing, a
receptacle for the active substance, an injection piston that is
displaceable in the receptacle for the purpose of expelling the
active agent, and a needle protecting device that is displaceable
relative to the housing.
[0003] A task of needle protecting or covering device is to protect
persons from unintentional injury by an injection needle after the
use of an injection apparatus. An advantage of such devices is also
that the patient is spared a view of the injection needle, which is
felt as unpleasant by many people. Needle protecting devices, caps
or covers are known in many forms, both in connection with manually
operated syringes and with so-called autoinjectors.
[0004] For example, the document WO09714455 describes an
autoinjector having a needle protecting sleeve that is displaceable
in a housing, including a sleeve which during the injection rests
against the skin of the patient and is prestressed by a spring such
that, upon retraction of the autoinjector, the needle protecting
sleeve is pushed forward relative to the autoinjector and covers
the injection needle. Locking means operative between the needle
protecting sleeve and the housing ensure that the needle protecting
sleeve cannot be pushed back again and, thus, that no unintentional
injury by the injection needle can occur. Means for canceling or
releasing the locking are not disclosed.
SUMMARY
[0005] In one embodiment, the present invention provides for an
injection device and method wherein, during skin penetration of an
injection needle associated with the device, a needle protecting
device remains in an substantially constant position relative to a
housing and, in the process, a spring element is stressed, which
spring element, after the removal of the injection needle from the
skin, pushes the needle protecting device forward into a position
in which the needle is substantially covered or surrounded.
[0006] In one embodiment, the present invention comprises an
injection device comprising a receptacle or container for an active
substance, which is connected to an injection needle and is
accommodated inside a sliding sleeve that can be displaced within a
housing by means of a driving force. A sleeve-shaped
needle-protecting device is displaceable within the housing by
means of a spring such that said needle-protecting device moves
forward and extends past the injection needle in an axial direction
when the injection needle is withdrawn from the body tissue. A lock
prevents the needle-protecting device from being manually pushed
backward, the lock effective between the needle-protective device
and the sliding sleeve, and being automatically deactivated when
the sliding sleeve is at least approximately back in its retracted
position.
[0007] An embodiment of the invention is characterized in that the
receptacle is accommodated inside a sliding sleeve, which during
the skin penetration is shifted in the housing from a retracted
position into an advanced position, that the needle protecting
device in its advanced position is automatically locked by locking
means, which are arranged and designed such that they are operative
between the needle protecting device and the sliding sleeve when
the needle protecting device and the sliding sleeve are located in
their advanced position, and that means for disengaging the locking
means are present, which disengaging means are operative when the
sliding sleeve is located at least approximately in its retracted
position.
[0008] The needle protecting device is thus not, as in many known
devices of this type, locked against the housing, but rather the
sliding sleeve, and the means for disengaging the locking mechanism
are operative only when the sliding sleeve is located at least
approximately in its retracted position. This provides the
advantage that the injection needle is already situated again
inside the housing when the locking mechanism is disengaged.
Consequently, in any operating state of the autoinjector it is
ensured that the injection needle cannot be unintentionally
touched.
[0009] According to a further embodiment of the invention, the
locking means displays at least one flexible tongue that is
arranged on the sliding sleeve and is oriented in an essentially
axial manner, which flexible tongue, in its relaxed state, forms an
axial stop with a region of the needle protecting device. Further,
the means for disengaging the locking mechanism display an
inward-jutting projection arranged in the housing, which projection
in the retracted position of the sliding sleeve presses the
flexible tongue in a radially-inward manner, in such a way that the
part of the sliding sleeve containing the flexible tongue can slip
into the region of the needle protecting device. Through these
measures, an autoinjector can be realized in a simple and
cost-effective manner and, moreover, has a relatively short
structural length.
[0010] According to another embodiment of the invention, a spring
element is present which presses the needle protecting device into
its advanced position and which is stressed by the sliding sleeve
when the latter moves into its advanced position. This has the
advantage that the needle protecting device is not pushed in the
direction of the skin of the patient until the needle is stuck
in.
[0011] A further embodiment of the invention provides for the
presence of carrier means that cause the needle protecting device
to be carried along by the sliding sleeve when the latter is guided
from its advanced position into the retracted position. It is thus
no longer necessary to manually push the needle protecting device
back into the housing after unlocking has taken place. If, in
addition, a restoring spring is provided, which acts on the sliding
sleeve with a restoring force in the direction of its retracted
position, then both the sliding sleeve and the needle protecting
device automatically assume the retracted starting position when
the driving force ceases.
BRIEF DESCRIPTION OF THE DRAWINGS
[0012] FIG. 1 shows a longitudinal section through an exemplary
embodiment of an autoinjector according to the invention, in the
loaded state;
[0013] FIG. 2 shows a longitudinal section through the same
autoinjector after the insertion of the injection needle and the
expelling of the medication, the sectional plane being shifted by
90.degree. with respect to that of FIG. 1;
[0014] FIG. 3 shows a longitudinal section through the same
autoinjector after the withdrawal of the injection needle, the
sectional plane being the same as in the representation according
to FIG. 1;
[0015] FIG. 4 shows a longitudinal section through the front part
of the autoinjector after the syringe has reverted to the starting
position and is ready for removal, the sectional plane being the
same as in the representation according to FIG. 1.
DETAILED DESCRIPTION OF THE DRAWINGS
[0016] An autoinjector in accordance with the present invention
comprises two main components, namely the reservoir part, shown on
the left in the figures, which accommodates a filled syringe 50,
and the power pack, shown on the right in the figures, in which are
accommodated the parts serving automatic insertion and expelling of
the substance to be administered. The two main components are
detachably connected to each other via a bayonet-like connection
between a housing 16 and a power-sleeve 1. In the following
description, the side of the autoinjector at which the injection
needle 37 is located is referred to as the front.
[0017] With reference to FIG. 1, which shows an operation-ready
autoinjector, the power pack is first described. The parts for the
propulsion of the injector are accommodated in the grip housing 14,
to the rear end of which an indicator window 51 is attached. The
indicator window 51 is, for example, produced from a transparent or
translucent material, so that the indicator 12 displaceably held in
the indicator window 51 can be observed from the outside. The
indicator 12 permits the user to optically follow the process of
the expelling of the medication. Arranged at the rear end of the
autoinjector is the actuation knob 13, which at its rearward face
side is provided with a cover disc 15. The power sleeve 1 is
accommodated inside the grip sleeve 14. At its rear end, the power
sleeve 1 is connected to a catch sleeve 8 by means of a snap
connection. The catch sleeve 8, for its part, displaceably
accommodates a spring sleeve 10 in its interior. The spring sleeve
10 is coupled at the rear to the indicator 12 through a snap
connection. At the front side of the spring sleeve 10, the transfer
part 5 is displaceably seated in the power sleeve 1. The transfer
part 5 has the task of actuating the piston rod 52 of the syringe
50 in order to expel the contents of the syringe, as will be
described below. Within the spring sleeve 10, a spring 9 is
accommodated in a stressed state, which spring is supported at the
front on the spring sleeve 10 and at the rear presses against the
catch sleeve 8. A second spring 11, likewise in the stressed state,
is located outside the spring sleeve 10 and is supported at the
front against the transfer part 5 and at the rear presses against
the spring sleeve 10.
[0018] A piston guide 4 is situated with its front, sleeve-shaped,
slotted end 4' against the shoulder of the syringe 50 and extends
through the transfer part 5, the spring sleeve 10, and the catch
sleeve 8 into the region of the actuation knob 13. The piston guide
4 is prestressed forward by means of a spring 7, which is supported
at the rear against the catch sleeve 8. At its rear end, the piston
guide 4 is held in the position shown in FIG. 1 by two catch lobes
31 formed on the catch sleeve 8, which lobes engage a groove 32
formed on the rear end of the piston guide 4. Catch members, for
example balls 6 (visible in FIG. 2), which are accommodated in
radial openings 33 of the piston guide 4 and engage depressions 34
in the transfer part 5, ensure in this operating position that the
transfer part 5 and the piston guide 4 can only move in common.
Instead of balls 6, any suitable mechanism or body can also be used
as catch members, for example pins.
[0019] The description of the reservoir part now follows. The parts
for the accommodation of the syringe 50 are, as mentioned, placed
in the housing 16, which is connectable to the power sleeve 1, as
described. A sliding sleeve 21 accommodates in itself the syringe
50 with the interposition of a needle holder 22 (FIG. 2). The
needle holder 22 ensures, in the case of luer slip couplings, that
the injection needle 37 cannot be withdrawn from the syringe so
long as the latter is located in the autoinjector. Toward the
front, the needle holder 22 lies against a support ring 24
connected to the sliding sleeve 21. In the case of syringes and
needles with luer lock couplings, in which therefore the injection
needle is connected to the syringe by means of a thread, no needle
holder 22 is present. The sliding sleeve 21 is displaceable within
the housing 16 and is pressed by a spring 20 into the operating
position showing in FIG. 1. For this purpose, the spring 20, which
in the operating position according to FIG. 1 is located in its
only slightly prestressed state, supports itself at the front
against a circular inner step 39 of the housing 16 and at the rear
against a outward-projecting brim of the sliding sleeve 21. A
sleeve-shaped needle protecting device 17 is displaceable within
the housing 16. The needle protecting device 17 is closed toward
the front by means of a snap cover 23, which leaves open a passage
for the injection needle 37 and has an inward-pointing flange 35 at
its rear end. A spring 18 is supported at the front against the
snap cover 23 and at the rear against an carrier ring 19, which for
its part is supported, in the operating position according to FIG.
1, against the flange 35. Consequently, in the operating position
according to FIG. 1, in which the spring 18 is only slightly
prestressed, this spring has no effect, because its remaining
prestress force is taken up by the needle protecting device 17.
[0020] Before an injection can be triggered, the autoinjector must
be unlocked. For this purpose, the actuation knob 13 is moved
toward the rear. In the process, at the front edge of the actuation
knob 13 a region of the indicator window 51 becomes open, at the
inside of which a conspicuously colored warning sleeve becomes
visible, indicating clearly that the autoinjector is now unlocked
and ready for the injection. With the unlocking movement, tongues
36 formed on the inside of the cover disc 15 of the actuation
button 13 slide over the catch lobes 31 formed on the catch sleeve.
The tongues 36 and the catch lobes 31 are here shaped such that the
tongues 36 yield elastically in a radial direction while they slide
over the ends of the catch lobes 31, which hold fast the piston
guide 4 by engaging the mentioned grooves 32. After the unlocking
movement, the tongues 36 formed on the actuation knob 13 are
situated between the catch lobes 31 in the manner of wedges.
[0021] The autoinjector is now ready for the injection and is
placed with the snap cover 23 at the desired location on the skin
of the patient. Since the needle protecting device 17 has axial
play in the housing 16, it moves toward the rear upon being placed
against the skin, until the flange 35 rests against the step 39.
The patient holds the autoinjector firmly at the grip sleeve 14 and
moves the actuation knob 13 forward, i.e. in the direction of his
or her body. In this triggering movement, the tongues 36 press
between the catch lobes 31 and spread these radially away from each
other, whereby the piston guide 4 is released and thrust forward
through the force of the spring 7. The sticking-in motion is also
assisted through the force of the springs 9 and 11, which act upon
the transfer part 5. Since the transfer part 5 is connected to the
piston guide 4 via the balls 6, there exists a spring system
consisting of the springs 7, 9, and 11 having a relatively high
starting force, which contributes to the reliable advancing of the
injection needle to the full penetration depth. The force of the
springs is transferred to the shoulder of the syringe 50 via the
sleeve-shaped front end 4' of the piston guide 4 and pushes this
shoulder, along with the sliding sleeve 21 in which it is
accommodated, in a forward direction, so that the injection needle
37 is advanced and the skin of the patient penetrated. The front
end of the sliding sleeve 21 moves into the needle protecting
device 17, taking along with it the carrier ring 19 on its provided
flexible tongues 38 and thus stressing the spring 18. With this
insertion motion, the sliding sleeve 21 also compresses the spring
20. The insertion stroke is limited through the abutting of the
shoulder 40 of the piston guide 4 against an inner step 41 of the
power sleeve 1. In this end position, the openings 33 in the piston
guide 4, which accommodate the balls 6, align with depressions 42
provided in the power sleeve 1, the balls 6 can give way radially
to the outside, and the coupling between the piston guide 4 and the
transfer part 5 is canceled. Simultaneously, the piston guide 4 is
now locked against the power sleeve 1, so that the force of the
spring 20 is absorbed by the power sleeve and does not counteract
the force of the spring 7. The injection now begins automatically,
as the piston rod 52 of the syringe 50 is further thrust forward by
the transfer part 5 under the force of the springs 11 and 9 and
thereby the medication contained in the syringe 50 is expelled.
FIG. 2 shows the just-described operating state of the
autoinjector, in which the medication has been completely expelled,
as can be seen in the figure through the position of the piston rod
of the syringe 50. The user can clearly recognize this operating
state by the position of the indicator 12 in the indicator window
51. Labeled with reference numeral 57 is the body tissue of the
patient, in which the injection needle 37 remains.
[0022] Starting from the operating position represented in FIG. 2,
the user can now retract the autoinjector, which then changes over
to the operating position represented in FIG. 3. The spring 18,
which, as described, was prestressed during the insertion process,
ensures that the needle protecting device 17 remains in contact
with the skin of the patient during the retraction of the
autoinjector. Thus, during the withdrawal of the injection needle
37 the needle protecting device 17 shifts forward relative to the
housing and to the sliding sleeve 21, until it completely covers
the injection needle 37. The flexible tongues 38 snap outward
behind the flange 35 of the needle protecting device 17 and prevent
the needle protecting device 17 from being pushed back into the
housing 16, as can be clearly seen in FIG. 3. Through this means,
any further, undesired stick injury by the injection needle is
eliminated. Small hooks 58 (FIG. 2), which are formed on the
sliding sleeve 21 at the front and against which the flange 35 of
the needle protecting device 35 rests, prevent the needle
protecting device 17 from falling out of the housing 16 toward the
front. If one attempts to push the needle protecting device 17 back
into the housing 16, for example through pressure on the snap cover
23, this is prevented through the fact that the pressure is passed
via the flexible tongues 38 to the sliding sleeve 21, from this to
the syringe 50, and from this to the piston guide 4. The latter is,
as mentioned, locked to the power sleeve 1 by the balls 6, so that
the needle protecting device 17 cannot be pushed back into the
housing 16 even with considerable expenditure of force. As a
result, persons who handle the autoinjector are reliably protected
from being unintentionally injured again by the injection needle 37
after a successful injection.
[0023] In order to prepare the autoinjector for another use, the
housing 16 and the power sleeve 1 are separated from each other
through disconnection of the bayonet-type connection. Through this,
both the force exerted on the piston rod 52 of the syringe 50 by
the springs 9 and 11 via the transfer part 5 and the force exerted
on the shoulder of the syringe 50 by the spring 7 via the piston
guide 4 are eliminated, so that now the spring 20, having been
stressed during the insertion, pushes the sliding sleeve 21,
relative to the housing 16, back to its rearward end position. In
the process, the sliding sleeve 21, via its hooks 58, also carries
along the needle protecting device 17. FIG. 4 shows the reservoir
part in this operating position, in which the spent syringe 50 can
now be removed and replaced with a new one.
[0024] While exemplary embodiments, including preferred
embodiments, of the present invention have been described herein,
it is contemplated that various modifications could be made without
deviating from the spirit of the present invention. Accordingly, it
is intended that the scope of the present invention be dictated by
the appended claims.
* * * * *