U.S. patent application number 14/242315 was filed with the patent office on 2015-02-05 for safety needle assembly.
This patent application is currently assigned to Novo Nordisk A/S. The applicant listed for this patent is Novo Nordisk A/S. Invention is credited to Karsten Jensen, Niels Nymark.
Application Number | 20150038903 14/242315 |
Document ID | / |
Family ID | 8160860 |
Filed Date | 2015-02-05 |
United States Patent
Application |
20150038903 |
Kind Code |
A1 |
Jensen; Karsten ; et
al. |
February 5, 2015 |
Safety Needle Assembly
Abstract
The invention relates to a safety needle assembly for injecting
a fluid into a human body comprising a cylindrical housing with a
bottom surface supporting a needle cannula and a shield
telescopically movable relative to the housing. A spring located
within the housing urges the shield in a distal needle covering
direction and a locking member also provided inside the housing
moves simultaneously with the shield during injection and
automatically locks the shield in a position where the sharp end of
the needle cannula is concealed thereby irreversible immobilizing
the safety needle assembly.
Inventors: |
Jensen; Karsten; (Hjorring,
DK) ; Nymark; Niels; (Hjorring, DK) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Novo Nordisk A/S |
Bagsvaerd |
|
DK |
|
|
Assignee: |
Novo Nordisk A/S
Bagsvaerd
DK
|
Family ID: |
8160860 |
Appl. No.: |
14/242315 |
Filed: |
April 1, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
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12899214 |
Oct 6, 2010 |
8728027 |
|
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14242315 |
|
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|
12470098 |
May 21, 2009 |
|
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12899214 |
|
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|
10978760 |
Nov 1, 2004 |
7553293 |
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12470098 |
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10307054 |
Nov 29, 2002 |
6855129 |
|
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10978760 |
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60343045 |
Dec 22, 2001 |
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Current U.S.
Class: |
604/110 |
Current CPC
Class: |
A61M 5/3245 20130101;
G09F 1/04 20130101; B42D 15/00 20130101; A61M 5/326 20130101; A61M
2205/6063 20130101; A61M 5/002 20130101; A61M 2005/3247 20130101;
A61M 2205/584 20130101; A61M 2005/3267 20130101; A61M 5/3271
20130101 |
Class at
Publication: |
604/110 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
Nov 30, 2001 |
DK |
PA 2001 01772 |
Claims
1. A Safety needle assembly comprising: a cylindrical housing
having a top surface and a bottom surface, said housing having
means for mounting said housing onto a medical injection device, a
needle cannula mounted in the bottom surface, said needle cannula
having a distal end located at a distal side of the bottom surface.
a shield telescopically movable relatively to the housing for
movement between a distal position where the shield covers the
distal end of the needle cannula and a proximal position where at
least a part of the distal end of the needle cannula is exposed, a
spring located inside said housing urging the shield in the distal
direction, a locking element provided inside the housing and having
at least one outwardly pointing locking protrusion wherein said
locking element is a separate part provided between the spring and
the shield and longitudinal moved simultaneously with the shield
relatively to the housing during use, whereby the locking
protrusion provided on the locking element is guided from a first
position where the shield is in the distal position, via a second
position where the shield is in the proximal position to a third
position where the shield is in the distal position and in which
third position at least one of the locking protrusions is blocked
by a blocking surface provided on the inside surface of the housing
whereby further movement of the shield is irreversible
immobilized.
2. A safety needle assembly according to claim 1, wherein the
locking protrusion of the locking element in the first position
abuts a stud provided on the shield and a fin provided on the
inside surface of the housing.
3. A safety needle assembly according to claim 2, wherein the
locking element and the locking protrusion rotates relatively to
the housing and the shield when an angled surface of the stud
aligns an angled surface of the fin.
4. A safety needle assembly according to claim 3, wherein the
locking protrusion of the locking element in the second position
abuts a toothed ring provided at the proximal end of the
shield.
5. A safety needle assembly according to claim 4, wherein the
locking protrusion of the locking element in the third position is
arrested in an opening in a longitudinal rib provided on the inside
surface of the housing, which opening defines the blocking
surface.
6. A safety needle assembly according to claim 5, wherein the
guiding means for guiding the locking protrusion of the locking
element comprises the ribs and the fins provided on the inside
surface of the housing, which ribs and fins extends only in the
horizontal direction.
7. A safety needle assembly according to anyone of the claim 1
wherein the shield is mounted inside the housing and penetrates
through an opening at the top surface of the housing.
8. A safety needle assembly according to claim 7, wherein the
spring interfaces the locking element and the bottom surface of the
housing.
9. A safety needle assembly according to claim 8, wherein the
housing is provided with a window through which window the locking
protrusion is visible when the locking protrusion is in its third
position.
Description
CROSS REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 12/899,214, filed Oct. 6, 2010, which is a continuation of U.S.
application Ser. No. 12/470,098, filed May 21, 2009, which is a
continuation of U.S. application Ser. No. 10/978,760, filed Nov. 1,
2004, now U.S. Pat. No. 7,553,293, which is a continuation of U.S.
application Ser. No. 10/307,054, filed on Nov. 29, 2002, now U.S.
Pat. No. 6,855,129, and claims the benefit of priority of U.S.
Provisional Application No. 60/343,045, filed Dec. 22, 2001 and
Danish Application PA 2001 01772, filed Nov. 30, 2001; the contents
of all of which are hereby incorporated by reference in their
entirety.
FIELD OF THE INVENTION
[0002] The invention relates to a safety needle assembly, which
reduces the risk of accidental needle-stick injuries, and
especially a safety needle assembly where a needle cannula is
mounted in a hub.
DESCRIPTION OF RELATED ART
[0003] Needle assemblies are commonly used to either inject
substances into or extract substances out of human or animal
bodies. Such needle assemblies are typically disposable and are
discarded after only one use. The problem presented by the disposal
of a needle assembly, and indeed, by any handling of the needle
assembly, is the potential risk of being injured by the sharp end
of the needle cannula. This is particular dangerous when following
after the penetration of a patients skin since the needle cannula
then may be contaminated and therefore capable of spreading
diseases such as hepatitis and HIV.
[0004] A great number of safety needle assemblies has been
developed where the needle cannula is concealed by a telescopically
movable shield during the injection.
[0005] One such prior art needle protection system is disclosed in
WO 01.76665. This safety needle comprises a hub with a centrally
located needle cannula. A telescopically movable shield is provided
on the outside surface of the hub. The shield is telescopically
movable between a first position where it fully covers the needle
cannula and a second position where a part or the needle cannula is
left free to perform an injection. A cam element, rotatable mounted
to the hub is provided with at least one cam, which cam is guided
in cam curve provided in the inside surface of the shield. The
shield is urged in the distal direction by a spring cocked between
the hub and the shield. The cam curve is adapted to block the cam
in a blocking position when the shield returns to the first
position after an injection has been performed.
[0006] The safety needle assembly disclosed in WO 01.76665 is
however rather cumbersome and consist of a large number of parts
that must be moulded and afterwards fitted together very precisely
in order to obtain the correct movement of the cam follower.
[0007] It is also a fact that the different plastic parts of an
assembled construction have a tendency to change the relative
dimensions when the construction is sterilized using steam or gas.
This is especially critical when the tolerances have to be very
narrow, as in the safety needle assembly disclosed in WO
01.76665.
[0008] In order to assure that the cam element of WO 01.76665 in
fact shifts into the locked position when the protective cap moves
back to the initiate position after an injection has been made, a
rather powerful spring is needed. This is an inconvenience for the
user, since the user has to press the protective cap in the
proximal direction literally with the use of his or hers skin while
making the injection.
DESCRIPTION OF THE INVENTION
[0009] It is henceforth an object of the present invention to
provide a safety needle assembly, which overcomes the
inconveniences of the prior art safety needle assemblies, and
especial to provide a safety needle assembly which is made from
fewer parts, and which parts are not subject to very strict
tolerances.
[0010] It is further an objective of the present invention to
provide a safety needle assembly having a spring with only a
limited force thereby offering the user maximum comfort.
[0011] In order to overcome the drawbacks of the prior art it is
suggested to provide the safety needle assembly with a separate
locking element located between the spring and the shield.
[0012] When the locking element is provided as a separate element
located between the spring and the shield and moved simultaneously
with the shield, the locking protrusion can be guided during the
longitudinal movement of the locking member thereby eliminating the
need for tracks or cams thus making it possible to construct the
safety needle assembly from only three plastic part in addition to
the hub.
[0013] Since there are no tracks or cams as such the internal
tolerances are not that important, and the friction can be kept
rather low which renders it possible to utilize a somewhat soft
spring, which enhances the user comfort.
[0014] By blocking the rotational movement of the locking
protrusion with a fin provided on the inside surface of the
housing, it is possible to define when the rotatable movement of
the locking protrusion should commence simply by specifying a
specific length of the fin.
[0015] Once the locking protrusion on the locking element has
passed over the end of the fin it will be impossible to move the
locking protrusion backwards. The length of the fins can be made
such that once the shield has been activated and the needle cannula
has emerged from the opening in the shield it will be impossible to
abort the injection and keep the needle for later use.
[0016] When the locking protrusion engages the toothed ring of the
shield, the shield can be moved all the way back in the proximal
direction thereby uncovering the needle cannula.
[0017] When the injection is over and the locking protrusion is
arrested in the opening in the longitudinal rib, it is virtually
impossible to advance the needle cannula again by pressing the
shield backwards in the proximal direction.
[0018] The guiding means for guiding the locking protrusion
comprises only horizontally difined ribs and fins. This makes both
the moulding of the parts and the assembly of the parts very
simple.
[0019] By mounting the shield inside the housing, it is ensured
that the shield cannot be separated from the housing.
[0020] When the spring cocked between the locking element and the
hub interfaces both the locking element and the bottom surface of
the housing, it is ensured that the spring can be added to the
assembly in a very simple manner.
[0021] By providing the housing with a window through which the
locking protrusion can be viewed when it is in the arrested
position, it is ensured that a user can visible inspect whether the
safety needle assembly has been used before or not.
[0022] The part of the shield and/or the locking element that are
visible through the window when the safety needle assembly is in
the unused condition can also be coloured in a colour indicating
that the safety needle assembly is ready for use.
[0023] The window can either be transparent or simply an opening in
the sidewall of the housing.
[0024] In the present context, the term "moving simultaneous" which
are used to describe the relationship between the movement of the
shield and the locking element, does not necessary mean that the
shield and the locking protrusion moves with the same speed. The
relative speed of movement is defined by the various angled
surfaces, and is therefore variable. The term "moving
simultaneously" merely means that both the shield and the locking
protrusion move at the same time.
BRIEF DESCRIPTION OF THE DRAWINGS:
[0025] The invention will be explained more fully below in
connection with a preferred embodiment and with reference to the
drawings in which:
[0026] FIG. 1 Shows a perspective view of the safety needle
assembly according to the invention.
[0027] FIG. 2 Shows an exploded view of the safety needle assembly
according to the invention.
[0028] FIG. 4 Shows a perspective view of the locking element.
[0029] FIG. 5 Shows a perspective view of the body of the
housing.
[0030] FIG. 6 Shows a schematically view of the body of the
housing.
[0031] FIG. 7 Shows a schematically view of the safety needle
assembly according to the invention.
[0032] FIG. 8 Shows a schematically view of the safety needle
assembly according to the invention, with a part of the housing cut
away.
[0033] FIG. 9 Shows the locking protrusion in its first
position.
[0034] FIG. 10 Shows the locking protrusion in or moving towards
its second position.
[0035] FIG. 11 Shows the movement of the locking protrusion moving
from the second to the third position.
[0036] FIG. 12 Shows the locking protrusion in the third
position.
[0037] FIG. 13 Shows a perspective view of an embodiment of the
safety needle assembly according to the invention.
[0038] FIG. 14 Shows a part of the housing of an embodiment of the
safety needle assembly according to the invention.
[0039] FIG. 15 Shows an exploded view of the safety needle assembly
according to the invention.
[0040] FIG. 16 Shows a perspective view of the safety needle
assembly stored in a container.
[0041] The figures are schematic and simplified for clarity, and
they just show details, which are essential to the understanding of
the invention, while other details are left out. Throughout, the
same reference numerals are used for identical or corresponding
parts.
DETAILED DESCRIPTION OF EMBODIMENT
[0042] Initially it may be convenient to define that, the term
"distal end" is meant to refer to the end of the safety needle
assembly inserted into the patient, whereas the term "proximal end"
is meant to refer to the end connected to the injection device.
[0043] FIG. 1 shows a safety needle assembly comprising a housing 1
and a shield 2, the housing 1 is made up from a hub 3 and a body 4.
The hub 3 and the body 4 is normally glued or welded together.
[0044] The connecting surface 5 between the hub 3 and the body 4 is
in the figures shown in a specific position, but could off cause be
located as wanted. The hub 3 and the body 4 could even be moulded
as one piece closed at the top surface 6 by a lit. The top surface
6 is provided with an opening 8 through which the shield 2
appears.
[0045] The shield 2 is provided with a needle outlet 7 through
which the needle cannula 30 can penetrate. The proximal end of the
shield 2 is, as shown in FIG. 2, provided with eight outwardly
projecting studs 10, which studs 10 has a planar fore front 11 and
an angled back front 12.
[0046] The housing 1 has a bottom surface 9 in the centre of which
the needle cannula 30 is mounted. The needle cannula 30 can either
be mounted such that a part of needle cannula 30 projects from the
bottom surface 9 in the proximal direction, which is preferred for
use with cartridges, or it can be mounted without this so called
back needle, which is preferred for hypodermic syringes. Adjacent
the bottom surface 9, at the proximal end of the housing 1, means
are provided for mounting the safety needle assembly on to an
injection device. These means would normally be a thread 35 such
that the safety needle assembly can be screwed onto a pen
syringe.
[0047] FIG. 3 shows the shield 2 seen from the proximal end. The
eight studs 10 are separated from each other by eight equally sized
spaces 26. The angular back front 12 of the studs 10 forms together
with the shield 2 a toothed ring 13 where the centre of the studs
10 forms the tops and the shield 10 within the spaces 26 forms the
valleys.
[0048] The locking element 16 seen in FIG. 2 is on the proximal
outside surface provided with four locking protrusions 17. These
locking protrusions 17 have, as shown in FIG. 4, an angled fore
front 18 and a planar back front 19.
[0049] The body 4 of the housing 1 is in FIG. 5 shown in
perspective and in FIG. 6 in a sectional view. The body 4 is
provided with four windows 20 and one longitudinal rib 21 for each
window 20. The ribs 21 are provided on the inside surface of the
body 4. These longitudinal ribs 21 extend through the entire length
of the body 4 although divided into two parts (21a, 21b) by the
windows 20. The distal part of this rib 21 is moulded uniform with
a collar 24 provided at the distal end of the body 4 and terminates
in a planar surface 14 at the distal end of the window 20. The
proximal part of the rib 21 terminates at the proximal end of the
window in a blocking surface 15, the use of which will be explained
later. At the distal end of the body 4 there is provided four fins
22. These fins 22 is moulded uniform with the collar 24 at the
distal end of the body 4, and has at the proximal end an angled
surface 23 which terminates approximately in a position adjacent
the middle of the windows 20.
[0050] Although the embodiment here described has eight studs 10,
four locking protrusions 17 and four windows 20, these parts could
be provided in a different number, as shown in FIG. 15.
[0051] When the safety needle assembly shown in FIG. 2 is
assembled, a spring 25 is cocked between the bottom surface 9 of
the housing 1 and the locking element 16 urging the locking element
16 and the shield 2 in a distal direction. The planar forefront 11
on the studs 10 abuts the collar 24 such that the shield 2 is
connected to the body 4 of the housing 1.
[0052] The assembled safety needle assembly is shown in FIGS. 7 and
8. FIG. 8 illustrates the inside of the safety needle assembly with
the body 4 cut away.
[0053] The shield 2 is located such within the body 4 of the
housing 1 that each rib 21 and each fin 22 is located in the space
26 between two studs 10. The upper part 21a of the ribs 21 are
however not shown in FIG. 8, since this upper rib 21a is not
entirely necessary. The locking element 16 is thereafter mounted
such that the angular forefront 18 on each locking protrusion 17
abuts the angled back front 12 on four of the studs 10 of the
shield 2, whereby the side surface of the locking protrusion 17 and
the side surface of the studs 10 forms a straight line which line
abuts the side surface of the fins 22 of the body 4 of the housing
1.
[0054] Once the shield 2 and the locking element 16 is correctly
mounted within the body 4 of the housing 1, the spring 25 is
located around the needle cannula 30 and the body 4 and the hub 3
are sealed together, rendering the safety needle assembly ready for
use.
[0055] The movement of the locking protrusion 17 is schematically
shown in FIGS. 9-12, showing the relative position of one of the
locking protrusion 17 on the locking element 16, two of the studs
10 on the shield 2, one of the fins 22 on the inside surface of the
body 4 of the housing 1 and one of the ribs 21 also located on the
inside surface of the body 4 of the housing 1.
[0056] FIG. 9 illustrates the safety needle assembly in its initial
position, as shown in FIG. 8, with the shield 2 in its distal
position where the shield 2 covers the needle cannula 30. When the
shield 2 is pressed towards the skin of a user, the shield 2 and
with it the studs 10, are moved in a proximal direction as
indicated with the arrow 27. This movement also moves the locking
protrusion 17 on the locking element 16 in the proximal direction
against the force F of the spring 25.
[0057] Once the locking protrusions 17 is moved free of the fins
22, as shown in FIG. 10, the angled fore front 18 of the locking
protrusions 17 will slide along the angled back front 12 of the
studs 10 and the angled fore front 23 of the fins 22 as indicated
with the arrow 28. This movement will move the locking protrusions
17 into contact with the valleys of the toothed ring 13. Further
movement of the shield 2 and thereby the studs 10 in the direction
of the arrow 27 will only move the locking protrusions 17 further
in the proximal direction. The injection is then executed with the
shield 2 in its most proximal direction. The position of the fins
22 and the ribs 21 is such that the studs 10 are always guided
either by the fins 22 or by the ribs 21.
[0058] When the injection is over, the needle cannula 30 is
retracted from the skin of the user, which will cause the shield 2
with the studs 10 and the locking element 16 with the locking
protrusion 17 to move in the distal direction due to the impact of
the force F executed by the spring 25. The arrow 29 in FIG. 11
indicates this movement.
[0059] FIG. 12 illustrates how the force F of the spring 25 urges
the locking element 16 with the locking protrusion 17 and the
shield 2 with the studs 10 in the distal direction. When the angled
fore front 23 on the fins 22 aligns the angled back front 12 of the
studs 10, such that the two angled fore fronts 23, 12 form a
diagonal line, the angled fore front 18 of the locking protrusion
17 will slide along this line into a position where the locking
protrusion 17 is located between the upper part 21a and the lower
part 21b of the ribs 21 i.e. between the planar surface 14 of the
upper part 21a of the ribs 21 and the blocking surface 15 of the
lower part 21b of the ribs 21. In this position the locking
protrusion 17 and hence the locking element 16 and the shield 2 is
irreversible locked.
[0060] At the proximal end of the locking protrusion 17, the planar
back front 19 will abut or at least be blocked by the blocking
surface 15 on the ribs 21 of the body 4 of the housing 1, thereby
rendering it impossible to move the shield 2 in the proximal
direction. At the distal end, the angled fore front 18 of the
locking protrusion 17 will abut the toothed ring 13 of the shield 2
and since the planar forefront 11 of the studs 10 on the shield 2
abuts the collar 24 of the body 4 of the housing 1 it will not be
possible to move the shield 2 in the distal direction. Sideways the
studs 10 of the shield 2 will be arrested between the upper part 21
a of the ribs 21 and the fins 22. As a result of this it will be
impossible to move the shield 2 in any direction.
[0061] Instead of having the angled fore front 18 of the locking
protrusion 17 in abutment with the toothed ring 13 of the shield
when the injection is over, the front end 36 of the locking element
16 can be design to abut the inner top end 37 of shield 2 once the
locking protrusion 17 is in the locking position. This will make it
virtually impossible to squeeze the angled fore front 18 of the
locking protrusion 17 by pushing the shield 2 in the proximal
direction.
[0062] The body 4 of the housing 1 is provided with four windows 20
which windows 20 divides each of the four ribs 21 into an upper
part 21a and a lower part 21b. When the safety needle assembly has
been used, the locking protrusion 17 on the locking element 16 will
be located between the upper part 21a and the lower part 21 b of
the ribs 21, and will thus be visible through the window 20. The
locking protrusion 17, or a part of it, could be coloured in an
inflammatory colour, or provided with another indication, which
will render it very easy for a user to visibly inspect whether the
safety needle assembly has been used or not just by glancing at the
windows 20. The windows 20 could e.g. be provided as openings in
the wall of the body 4.
[0063] Prior to use, the safety needle assembly is delivered to the
user sterilized and contained as is shown in FIG. 7. The container
31 is closed at the distal surface 32 and open at the proximal
surface 33. The proximal surface 33 is sealed by a not shown
removable seal. The container 31 has on the inside surface not
shown ribs that mates ribs 34 located on the outside surface of the
housing 1 preferably on the hub 3, such that the safety needle
assembly can be screwed on and off a pen syringe without removing
the container 32 from the safety needle assembly. Further the
container could on the inside surface be provided with a number of
not shown raised points supporting the safety needle assembly in a
somewhat floating position making it easier for the steam or gas to
fully surround the safety needle assembly during sterilization in
case this type of sterilization is used.
[0064] The spring 30 urging the locking element 16 and the shield 2
in the distal direction is preferably made from stainless
non-corrosive steel such that the spring 30 will not be damaged
during the steam sterilization process. A spring 30 particular
suitable for this purpose is a 1.4462/SAF2205 spring.
[0065] Another embodiment of the safety needle assembly according
to the invention is disclosed in FIG. 13 and FIG. 14.
[0066] FIG. 13 shows a housing 40 comprising of a hub 41 and body
42. Mounted inside the housing 40 are a shield 43 and a locking
element 44. The shield 43 penetrates out of the housing 40 through
an opening 45 located at the distal end of the housing 40
[0067] The shield 43 is provided with four studs 46 and ends at the
proximal end in a toothed ring 38.
[0068] This toothed ring 38 engages a second toothed ring 39
located on the locking element 44. The locking element 44 is
further provided with a locking protrusion 49 located at the
proximal end thereof.
[0069] The needle cannula 30 is in FIG. 13 mounted in the bottom
surface 50, which bottom surface 50 is provided in the housing 40,
preferably in the hub 41.
[0070] FIG. 13 shows the safety needle assembly with the shield 43
in the locked position, and FIG. 14 illustrates the inside surface
of the housing 40 by showing the part of the housing 40 cut away in
FIG. 13 seen from the backside.
[0071] The four studs 46 on the shield 43 is guided in first
horizontal tracks 51 provided on the inside surface of the housing
40. The locking protrusion 49 on the locking element 44 abuts a
planar surface 48 in its initiate position and is guided in a
second horizontal track 52 as the shield 43 is moved in the
proximal direction. Once the shield 43 has been moved all the way
back to its most proximal position and the injection is executed, a
not shown spring positioned between the bottom surface 50 and the
locking element 44 will urge the locking element 44 and hence the
shield 43 in the distal direction. During this movement, the angled
fore front 47 of the locking protrusion 49 will engage a diagonal
track 53 also provided in the inside surface of the housing 40.
While the shield 43 moves back to its initiate position, the
locking element 44 and hence the locking protrusion 49 will rotate
approximately 180 degrees in the diagonal track 53 and engage a
locking chamber 54 provided at the distal end of the diagonal track
53, which locking chamber 54 has a blocking surface 55 that a
planar back front 56 of the locking protrusion 49 will abut
rendering further movement of the shield 43 impossible. The first
toothed ring 38 of the shield 43 and the second toothed ring 39 of
the locking element 44 support this movement due to mutual
engagement of the angled surfaces of the two rings 38, 39.
[0072] The shield 43 cannot be rotated relatively to the housing 40
due to the engagement of the studs 46 with the first horizontal
tracks 51. Since rotation of the shield 43 is inhibited it is
impossible to rotate the locking protrusion 49 of the locking
element 44 backwards in the diagonal track 53, and the locking
protrusion 49 will therefore remain in the locking chamber 54 thus
rendering the safety needle assembly secured.
[0073] A window could be provided in the housing 40 through which
window the locking chamber 54 can be viewed, such that the user can
get a visible indication whether the safety needle assembly has
been used or not.
[0074] An improved embodiment of the safety needle assembly
disclosed in FIGS. 1 to 12 is shown in FIG. 15 and in FIG. 16.
[0075] In the following the numbers referring to the same element
as in the previous figures has been given the same number plus one
hundred.
[0076] The safety needle assembly shown in FIG. 15 comprises a
housing made up from a needle hub 103 and a body 104 both
preferably injection moulded from PP. Both the hub 103 itself and
the tower of the hub 103 is somewhat higher than shown in FIG. 2,
while the body 104 is somewhat shorter. The needle cannula 130 is
inserted in the tower of the hub 103 and glued to the hub 103 by a
blob of glue 160.
[0077] The body 104 is in this embodiment provided with three
windows 120 and the locking element 116 is also provided with three
locking protrusions 117. When the locking element 116 locks the
safety needle assembly from reuse, the three locking protrusions
117 will be visible in the three windows 120 as earlier
explained.
[0078] The shield 104 which is preferably made from TPX can be
transparent such that the tip of needle cannula 130 is visible for
inspection by the user prior to injection, has on its proximal end
six studs 110. The toothed ring 113 formed between these studs 110
is therefore in this embodiment only provided with six valleys.
[0079] The locking element 116 which is preferably made from POM or
PP is on the distal end surface provided with a serrated ring 161
which are used during the manufacturing process. When the safety
needle assembly is being assembled a tool can enter the safety
needle assembly through the needle outlet 107 in the shield 102 and
engage this serrated ring 161 in order to rotate the locking
element 116 to the correct position before the shield 102 and the
locking element 116 is permanently encapsulated in the housing. For
this purpose the needle outlet 107 needs to be large enough for the
toll to pass through the needle outlet 107.
[0080] In the embodiment shown in FIG. 10 there exist a slight
possibility of rotating the shield 2 when the studs 10 are
longitudinal located between the fins 22 and the lower part 21b of
the ribs 21. In order to prevent such accidental rotation, the
studs 110 of the embodiment shown in FIG. 15 is provided with an
additional guiding rib 162 which are guided in a number of not
shown guiding tracks provided on the inside surface of the body 104
of the housing. Due to this no rotation between the shield 102 and
the body 104 is possible,
[0081] When the safety needle assembly is assembled the whole unit
is packed in a container 131 which container 131 is sealed with a
removable seal 163 and sterilized. The removable seal 163 is
preferably made from paper.
[0082] The distal part of the container 131 can be formed as a cup
164 holding a predetermined volume as shown in FIG. 16. The dosage
of an injection device to be used with the safety needle assembly
can thus be controlled by ejecting a predetermined number of doses
into the cup 164 and verifying the expelled volume. This can be
done either by filling the entire cup or by having indications
printed on the cup 164.
[0083] Some preferred embodiments have been shown in the foregoing,
but it should be stressed that the invention is not limited to
these, but may be embodied in other ways within the subject matter
defined in the following claims.
LIST OF PARTS
[0084] 1 Housing [0085] 2 Shield [0086] 3 Hub [0087] 4 Body [0088]
5 Connecting surface [0089] 6 Top surface [0090] 7 Needle outlet
[0091] 8 Opening [0092] 9 Bottom surface [0093] 10 Stud [0094] 11
Planar ore front of studs [0095] 12 Angled back front of studs
[0096] 13 Toothed ring [0097] 14 Planar surface [0098] 15 Blocking
surface [0099] 16 Locking element [0100] 17 Locking protrusion
[0101] 18 Angled front of locking protrusion [0102] 19 Planar back
front of locking protrusion [0103] 20 Window [0104] 21 Rib [0105]
21a Upper part of rib [0106] 21b lower part of rib [0107] 22 Fin
[0108] 23 Angled surface [0109] 24 Collar [0110] 25 Spring [0111]
26 Spaces on shield [0112] 27 Directional arrow [0113] 28
Directional arrow [0114] 29 Directional arrow [0115] 30 Needle
cannula [0116] 31 Container [0117] 32 distal surface of container
[0118] 33 proximal surface of container [0119] 34 Ribs on outside
surface of housing [0120] 35 Thread [0121] 36 Front end of locking
protrusion [0122] 37 Inner top end of shield [0123] 38 Toothed ring
of shield [0124] 39 Second toothed ring of locking element [0125]
40 Housing [0126] 41 Hub [0127] 42 Body [0128] 43 Shield [0129] 44
Locking element [0130] 45 Opening [0131] 46 Studs [0132] 47 Angled
fore front of locking protrusion [0133] 48 Planar surface [0134] 49
Locking protrusion [0135] 50 Bottom surface [0136] 51 First
horizontal track [0137] 52 Second horizontal track [0138] 53
Diagonal track [0139] 54 Locking chamber [0140] 55 Blocking surface
[0141] 56 Planar back front [0142] 102 Shield [0143] 103 Hub [0144]
104 Body [0145] 107 Needle outlet [0146] 110 Stud [0147] 113
Toothed ring [0148] 116 Locking element [0149] 117 Locking
protrusion [0150] 120 Window [0151] 125 Spring [0152] 130 Needle
cannula [0153] 131 Container [0154] 160 Glue [0155] 161 Serrated
ring [0156] 162 Guiding rib [0157] 163 Seal [0158] 164 Cup
* * * * *