U.S. patent application number 12/160046 was filed with the patent office on 2009-01-01 for medical needle safety device.
Invention is credited to Barry Peter Liversidge.
Application Number | 20090005742 12/160046 |
Document ID | / |
Family ID | 35911469 |
Filed Date | 2009-01-01 |
United States Patent
Application |
20090005742 |
Kind Code |
A1 |
Liversidge; Barry Peter |
January 1, 2009 |
Medical Needle Safety Device
Abstract
A safety device for a medical needle (10) has a tubular support
(14) for the needle mount end and a tubular protective shield (25)
slidably mounted on the support (14) from a set position to a
retracted position and then to a locked position where the shield
covers the needle. The shield (25) and support (14) are restrained
against relative rotational movement. A locking member (18) is
rotationally mounted on the support, within the shield, there being
a cam follower (22) on the support engaged with a cam profile (21)
on the locking member (18) whereby forward axial movement of the
support relative to the locking member causes the locking member to
rotate relative to the support. The shield (25) has a guide (27)
defining a shoulder (32) towards its rearward end and an abutment
(23) on the locking member (18) is receivable behind the shoulder
when the shield is in its locked position. A spring (38) acts
between the locking member (18) and the shield (25) whereby the
locking member is in use turned to engage its abutment (23) with
the shoulder (32) of the shield when the latter is in its locked
position, so preventing subsequent rearward movement (15)
thereof.
Inventors: |
Liversidge; Barry Peter;
(Essex, GB) |
Correspondence
Address: |
ANDRUS, SCEALES, STARKE & SAWALL, LLP
100 EAST WISCONSIN AVENUE, SUITE 1100
MILWAUKEE
WI
53202
US
|
Family ID: |
35911469 |
Appl. No.: |
12/160046 |
Filed: |
January 4, 2007 |
PCT Filed: |
January 4, 2007 |
PCT NO: |
PCT/GB2007/050004 |
371 Date: |
July 3, 2008 |
Current U.S.
Class: |
604/263 |
Current CPC
Class: |
A61M 5/3272 20130101;
A61M 5/3204 20130101; A61M 2005/3247 20130101; A61M 5/326
20130101 |
Class at
Publication: |
604/263 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Foreign Application Data
Date |
Code |
Application Number |
Jan 6, 2006 |
GB |
0600212.5 |
Claims
1. A safety device for a medical needle having a mount end and a
sharp tip, which device comprises: a tubular support adapted for
direct or indirect association with the needle mount end; a tubular
protective shield disposed co-axially on the support for sliding
movement with respect thereto from a set position where the shield
covers a needle with which the support is associated to a retracted
position where a part of the length of an associated needle back
from its tip is exposed, and then to a locked position where the
shield again covers the needle to afford protection thereto, the
shield and support being restrained against significant relative
rotational movement; a locking member rotationally mounted on the
support within the shield, there being a cam profile on one of the
locking member and support and a cam follower on the other of the
locking member and support whereby forward axial movement of the
support with respect to the locking member causes the locking
member to rotate relative to the support; a guide extending
generally axially of the shield and defining a shoulder towards the
rearward end thereof; an abutment on the locking member engageable
with the guide and receivable behind the shoulder when the shield
is in its locked position; a stop defined by the shield and
arranged for engagement by the abutment to hold the locking member
against rearward movement when the shield is in its set position;
and resilient means acting between the locking member and the
shield and arranged to urge the locking member rearwardly with
respect to the shield; whereby interaction between the cam profile
and cam follower turns the locking member with respect to the
support on rearward movement of the shield from its set position
relative to the support, thereby rotationally shifting the locking
member from the stop, and on subsequent forward movement of the
shield to its locked position, the locking member further turns to
allow engagement of the abutment with the shoulder of the shield,
thereby preventing subsequent rearward movement of the shield from
its locked position.
2. A safety device as claimed in claim 1, wherein the tubular
support defines a bore for receiving a needle holder supporting the
needle, thereby to permit the mounting of the device on the
needle.
3. A safety device as claimed in claim 1, wherein the tubular
support defines a cylindrical outer surface on which the locking
member is rotationally mounted.
4. A safety device as claimed in claim 3, wherein the outer surface
of the tubular support includes means to limit the forward movement
of the locking member with respect to the tubular support.
5. A safety device as claimed in claim 4, wherein said means to
limit co-acts with the cam profile to give the locking member a
limited degree of axial freedom with respect to the support.
6. A safety device as claimed in claim 1, wherein the guide
comprises one of a groove formed in the shield.
7. (canceled)
8. A safety device as claimed in claim 6, wherein the guide has a
central part and a rearward part of a greater circumferential
extent than the central part, and the shoulder is defined at the
junction between the central and rearward parts.
9. A safety device as claimed in claim 8, wherein the guide has a
forward part and said stop is formed between the central and
forward parts.
10. A safety device as claimed in claim 9 wherein the forward part
is of a greater circumferential extent than the central part and
the stop is defined by the junction between the central and forward
parts.
11. (canceled)
12. A safety device as claimed in claim 6, wherein the tubular
support includes an outwardly directed projection which is received
by the guide, thereby to restrain rotational movement between the
support and the shield.
13. A safety device as claimed in claim 1, wherein the cam profile
is formed on the locking member and the cam follower is provided on
the support.
14. A safety device as claimed in claim 13, wherein the locking
member has three essentially identical cam profiles disposed around
the periphery thereof, and the support has three equi-spaced cam
followers associated one with each cam profile respectively.
15. A safety device as claimed in claim 1, wherein there are three
guides formed within the shield and each having associated
therewith a respective shoulder and stop.
16. A safety device as claimed in claim 1, wherein the resilient
means comprises a helical compression spring.
17. A safety device as claimed in claim 16, wherein the forward end
of the shield has an inwardly directed flange said spring bearing
against the flange.
18. A safety device as claimed in claim 16, wherein the locking
member has an annular part and a cam profile part, the spring
acting on the annular part of the locking member to urge the
locking member rearwardly with respect to the shield.
19. A safety device as claimed in claim 1, wherein there is
provided a container for the shield, said container being open at
one end and having a wall at its other end said wall being provided
with a central hole for receiving a sheath of a needle.
20. A safety device as claimed in claim 1 in combination with a
medical needle provided within the tubular support and projecting
forwardly therefrom.
21. An injector comprising a syringe having a forwardly projecting
needle and a safety device as claimed in claim 1, with the support
thereof mounted on the syringe.
Description
[0001] This invention relates to a safety device for a medical
needle having a mount end and a sharp tip, intended for penetration
of a human or animal body, or for other medical uses such as the
penetration of a pierceable membrane of an intravenous medication
system. The invention further relates to a safety device including
a medical needle as aforesaid, ready for use. For convenience, in
the following all such medical uses will be described simply as the
penetration of a body, even though specific embodiments may be
intended for other medical uses.
[0002] Throughout this specification the terms forward and
forwardly used in relation to the safety device refer to the end
thereof which is approached to a body when a procedure is to be
performed, and the direction towards that end. Conversely, the
terms rearward and rearwardly refer to the end of the safety device
opposed to the forward end and the direction away from that forward
end.
[0003] Fluids of various kinds may be administered to a human or
animal body by means of a hollow needle in conjunction with a
source of the required fluid. For example, such a needle may be
used in conjunction with a syringe holding a liquid drug which may
be contained directly in the syringe barrel or in a cartridge
located within the syringe, the needle being used to penetrate the
body at the site at which the drug is to be received. Equally, body
fluids may be withdrawn by using a hollow needle which is used to
penetrate the body until the tip is located at the site from which
fluid is to be withdrawn.
[0004] A recognised hazard for clinicians and other persons using
medical needles for the above described purposes, as well as people
who may be exposed to used needles in the course of the disposal of
those needles, is the risk of a so-called needle-stick injury--that
is to say the accidental penetration of a person's skin by the
needle. Prior to the use of the needle to supply a fluid to or to
withdraw fluid from a body, this rarely presents much of a problem,
though once the needle has been used on a body, there is a very
much higher risk of a serious consequence for a person suffering a
needle-stick injury. During use of the needle to penetrate the body
tissues of a patient, the needle is likely to become contaminated
with various organisms; should a person subsequently suffer a
needle-stick injury, infection could occur.
[0005] There have been numerous proposals for protecting the sharp
tip of a used needle, in order to reduce the risk of a needle-stick
injury following use of the needle. Some proposals have actually
increased the likelihood of such an injury by virtue of the action
which must be performed to protect the tip, even if the risk
thereafter is lessened. Despite all of the proposals which have
previously been made, very few have achieved commercial success,
nor has there been wide acceptance by the medical industry. Many
proposals are somewhat complex and involve a significantly greater
manufacturing cost, and so are unacceptable on economic grounds.
Others are much more difficult to use as compared to an unprotected
needle, and so are rejected by clinicians. Yet further proposals do
not allow compliance with best practice protocols.
[0006] A device which protects a needle tip after use without an
operator having to perform any extra step on withdrawing the needle
from a body is usually referred to as a passive protection device.
This may be contrasted with an active protection device, where an
operator is required to perform an extra step in order to protect a
needle, following the withdrawal of the needle from a body. The
requirement to perform an extra step leaves the needle unprotected
for a longer period than with a passive protection device and
further the performance of that extra step exposes the operator to
a potentially hazardous situation, when needle-stick accidents can
occur.
[0007] There is a significant demand for a passive protection
device for use with a needle, and which allows a clinician or
perhaps others to use the needle in much the same way as is done
with an unprotected needle, but which can be manufactured
economically and which provides a high degree of protection against
needle-stick injury. In the case of health professionals, this
demand is driven by health and safety legislation but in the case
of others performing self-injections using a so-called pen
injector, the used needles must be disposed of safely with minimum
risk to others, even in the event that a sharps container is not
immediately available. Further, particularly for self-injections,
it is highly preferred that the device operates fully
automatically, without intervention by the user, so as wholly to
prevent access to the needle tip after use, other than by a
determined attempt to override the protection. In this way,
protection may be afforded not just to the clinician or other user
of the needle, but also to people who could come into a risky
situation with used needles, such as waste disposal operators,
cleaners, and so on.
[0008] Particularly in the case of a pen injector, it is
advantageous for a passive protection device to have three
positions: an initial or set position where the device is ready for
use preferably with a portion of the needle from its tip exposed
for performing the injection; an injecting position where the full
length of the needle is exposed and fully penetrates the body; and
a locked position where a shield wholly covers the needle and is
locked against movement thereby preventing exposure of at least the
needle tip.
[0009] The present invention aims at providing a safety device
advantageously in the form of an accessory for an injector, which
addresses these issues and which is both relatively simple and
economic to manufacture, especially on a fully automated production
line, and which does not significantly affect a conventional
injection procedure when mounted on an injector.
[0010] According to this invention, there is provided a safety
device for a medical needle having a mount end and a sharp tip,
which device comprises: [0011] a tubular support adapted for direct
or indirect association with the needle mount end; [0012] a tubular
protective shield disposed co-axially on the support for sliding
movement with respect thereto from a set position where the shield
covers a needle with which the support is associated to a retracted
position where a part of the length of an associated needle back
from its tip is exposed, and then to a locked position where the
shield again covers the needle to afford protection thereto, the
shield and support being restrained against significant relative
rotational movement; [0013] a locking member rotationally mounted
on the support within the shield, there being a cam profile on one
of the locking member and support and a cam follower on the other
of the locking member and support whereby forward axial movement of
the support with respect to the locking member causes the locking
member to rotate relative to the support; [0014] a guide extending
generally axially of the shield and defining a shoulder towards the
rearward end thereof; [0015] an abutment on the locking member
engageable with the guide and receivable behind the shoulder when
the shield is in its locked position; [0016] a stop defined by the
shield and arranged for engagement by the abutment to hold the
locking member against rearward movement when the shield is in its
set position; and [0017] resilient means acting between the locking
member and the shield and arranged to urge the locking member
rearwardly with respect to the shield;
[0018] whereby interaction between the cam profile and cam follower
turns the locking member with respect to the support on rearward
movement of the shield from its set position relative to the
support, thereby rotationally shifting the locking member from the
stop, and on subsequent forward movement of the shield to its
locked position, the locking member further turns to allow
engagement of the abutment with the shoulder of the shield, thereby
preventing subsequent rearward movement of the shield from its
locked position.
[0019] It will be appreciated that the device of this invention has
only three components plus the resilient means which conveniently
is in the form of a helical coil spring acting between the locking
member and the shield. Each of the components is essentially
tubular and so is relatively simple to manufacture by a plastics
moulding process. This enables automated and economic manufacture
on a large scale.
[0020] Preferably, the tubular support defines a bore within which
a needle holder may be received, either in a frictionally-engaging
or a mechanically interlocked manner. The needle holder may be
internally screw-threaded or otherwise formed for attachment to a
syringe and may have a hub within which is mounted the needle, so
as to project forwardly from the holder. The tubular support may
include an inwardly directed lip to define a limiting forward
position for a needle holder, with respect to that support.
[0021] The locking member is preferably mounted directly on an
external cylindrical surface of the tubular support, whereby the
locking member may both rotate and slide axially with respect to
that support. That outer support may include at least one
protrusion which limits the forward movement of the locking member
with respect to the tubular support, whereby the locking member is
given a limited degree of axial freedom, irrespective of the
rotational position of the locking member with respect to the
support--that is, there is lost axial motion between the locking
member and the support.
[0022] In a preferred embodiment, the guide comprises one of a
groove formed within the internal surface of the shield, or a slot
formed through the wall of the shield. Such a groove or slot may
have a forward part and a rearward part, the latter being of a
greater circumferential extent than the forward part whereby said
shoulder is defined at the junction between the forward and
rearward parts of the groove or slot. In the case of a groove, the
stop for the abutment may be provided within the groove, such that
the abutment is disposed in the forward part of the groove when the
abutment bears on the stop. If the guide comprises a slot through
the shield wall, the stop may take the form of a further shoulder
provided at the forward end of the slot, by a lateral extension to
the slot. In either case, initial forward movement of the support
from its set position will turn the locking member out of alignment
with the stop by virtue of the interaction of the cam profile and
follower while maintaining the abutment in the forward part of the
groove or slot.
[0023] In an embodiment where the guide comprises a groove in the
shield wall, the circumferential extent of the abutment on the
locking member should be smaller than the circumferential extent of
the projection on the support, such that when the abutment and
projection are in the forward part of the groove, the support is
restrained against rotational movement but the locking member is
permitted limited rotational movement sufficient to allow the
locking member to come out of alignment with the stop of the
groove.
[0024] In an alternative embodiment where the guide comprises a
slot through the shield wall and the stop is defined by a further
shoulder as aforesaid, the circumferential extent of the abutment
in the locking member may be not greater than the width of the
groove in the circumferential direction, so as to be a free sliding
fit therealong.
[0025] A preferred embodiment has the cam profile formed on the
locking member and the cam follower provided on the support.
Preferably, three such cam profiles are provided, spaced around the
locking member and there are three corresponding cam followers
equi-spaced around the support. Equally, the preferred embodiment
has a shield which defines three guides equi-spaced around the
shield and there is a like number of abutments on the locking
member, though other numbers of guides and abutments could be
employed.
[0026] This invention extends to a safety device of this invention
as described above in combination with a medical needle provided
within the tubular support and projecting forwardly therefrom.
Further, this invention also extends to an injector comprising a
syringe having a forwardly projecting needle (which may be
removably mounted thereon) and a safety device of this invention as
described above, with the support thereof mounted on the
syringe.
[0027] By way of example only, one specific embodiment of safety
device of this invention and for a medical needle will now be
described in detail, reference being made to the accompanying
drawings in which:
[0028] FIG. 1 is an exploded isometric view of the safety device
together with a so-called pen injector shown in part and having a
sheathed needle fitted to the forward end thereof;
[0029] FIG. 2 is an isometric view of the safety device disposed
within its container and being offered to a pen injector having a
sheathed needle fitted thereto;
[0030] FIG. 3 is an isometric view of the safety device having the
sheathed needle fully inserted therein;
[0031] FIG. 4 is an isometric view of the pen injector removed from
the container of the safety device, with the needle exposed ready
for performing an injection procedure;
[0032] FIG. 5 shows the safety device in its initial, set
position;
[0033] FIG. 6 shows the safety device with the shield fully
withdrawn from the needle, during the performance of an injection
procedure;
[0034] FIG. 7 shows the safety device with the shield in its locked
position protecting the needle following the performance of an
injection procedure;
[0035] FIG. 8 is a detail view of the support and locking member
fitted to a needle provided on the forward end of a pen injector;
and
[0036] FIG. 9 is a detail view on an enlarged scale of the tubular
shield, locking member and spring but with the other components
removed for clarity, when the locking member is in its initial, set
position.
[0037] Referring initially to FIG. 1 there are shown the components
making up the safety device for use with a medical needle which, in
this case, comprises a needle assembly 10 fitted to a pen injector
11. The needle assembly has an internally threaded holder 12 which
is screw-fitted to an externally threaded boss at the forward end
of the pen injector, the holder 12 supporting a needle which
projects forwardly therefrom and is fitted with a substantially
rigid sheath 13, removable for the performance of an injection.
Typically, the pen injector 11 supports a cartridge of medicament
having a piston at its rearward end and a bung at its forward end,
which bung is penetrated by a rearward extension of the needle
supported by the holder 12, as the holder is threaded to the
injector. The details of the injector form no part of this
invention and will not be discussed further, here.
[0038] The safety device comprises a tubular support 14 having a
bore within which the holder 12 is received, when the device is
fitted to the pen injector 11. As an alternative, the holder 12
could be provided within the tubular support 14 such that the
safety device is fitted to the pen injector by threading the needle
assembly holder 12 to the threaded boss of the injector. The
forward end of the support 14 has an inwardly directed lip 15 to
define a limiting position for the holder 12 within the support. At
the rearward end of the support is an external flange 16 provided
with three outward projections 17.
[0039] Rotatably mounted on the external surface of the support 14
is a locking member 18, as shown in more detail in FIG. 8. That
locking member is restrained on the support 14 by three protrusions
19 over which the locking member is snapped, during assembly of the
device. The locking member 18 has an annular part 20 which supports
three equi-spaced and essentially identical cam profiles 21, each
of which co-operates with a respective cam follower 22 formed on
the support 14 adjacent the external flange 16. Rotation of the
locking member 18 causes the member to move axially with respect to
the support, by virtue of the interaction of the cam profiles 21
with the cam followers 22. For any given rotational position of the
locking member, it has a limited degree of freedom in the axial
direction, defined by the protrusions 19 on the outer surface of
the support 14 and the interaction between the cam profiles and
followers 21,22. Three outwardly projecting abutments 23 are
provided on the external surface of the annular part 20 of the
locking member for a purpose to be described below.
[0040] The safety device further comprises a shield 25 having a
bore which is selected for use with a particular design of
injector, so as to be a sliding fit over the barrel 26 thereof. The
wall of the shield has three equi-spaced axially-extending slots 27
formed therethrough, from the forward end of the shield back
towards the rear end thereof. Each slot has a forward part 28, a
central part 29 and a rearward part 30, the circumferential extent
of the forward and rearward parts being greater than that of the
central part, whereby a first shoulder 31 is defined between the
forward and central parts and a second shoulder 32 is defined
between the central and rearward parts. The external flange 16 of
the support 14 is a free sliding fit within the bore of the shield
25, with the projections 17 received in the slots 27. When the
projections are in the central parts 29 of the slots 27, the
support is held against rotational movement with respect to the
shield, but when the projections are in the rearward parts 30, the
support may rotate through a limited extent defined by the greater
circumferential extent of the rearward parts of the slots (FIG. 7).
As will be described below, the arrangement is such that the
tubular support 14 cannot move sufficiently forwardly with respect
to the shield for the projections 17 to leave the central parts 29
of the slots 27.
[0041] The abutments 23 of the locking member 18 have substantially
the same circumferential extent as the projections 17 and are also
received within the slots 27. Thus, the abutments 23 may locate in
the forward parts 28 of the slots 27 as shown in FIGS. 5, 6 and 9
and also in the rearward part 30 of the slots as shown in FIG. 7.
When located in the forward parts 28, each abutment may engage
behind the respective first shoulder 31 (FIG. 5) by rotation of the
locking member 18 in one sense with respect to the sheath 13 and
support 14. When located in the rearward parts 30, each abutment
may engage behind the respective second shoulder 32 (FIG. 7) by
rotation of the locking member 18 in the opposed sense with respect
to the sheath 13 and support 14.
[0042] At its forward end, the shield 25 has an inwardly projecting
flange 34 with a central hole 35 through which the needle 36 of the
needle assembly 10 may, in use, project. The flange 34 has three
slots 37 formed therein, to permit the insertion of the prongs of
an assembly tool (not shown) for facilitating alignment of the
components described above, during manufacture of the device. A
helical compression spring 38 is disposed between the flange 34 and
the annular part 20 of the locking member 18, so as to urge the
locking member rearwardly with respect to the shield 25. The
support 14 is thus also urged rearwardly by virtue of the
interaction between the cam profiles 21 and cam followers 22 on the
locking member and support respectively, but subject to the limited
axial freedom between those components.
[0043] In the initial, set position of the device, the abutments 23
of the locking member 18 are located in the forward parts 28 of the
slots 27, engaged behind the respective first shoulders 31, so
holding both the locking member 18 and support 14 against rearward
movement with respect to the shield 25. The projections 17 of the
tubular support 14 are disposed in the central parts 29 of the
slots 27, so holding the support 14 against rotation with respect
to the shield. Relative rotation of the locking member with respect
to the shield allows the abutments 23 to come free of the first
shoulders 31 whereafter the locking member and support may move
rearwardly with respect to the shield. Once those components have
moved rearwardly sufficiently to bring the abutments 23 rearwardly
of the second shoulders 32, further rotation of the locking member
with respect to the shield will bring those abutments behind the
second shoulders and so prevent subsequent forward movement of the
locking member and support, with respect to the shield.
[0044] FIGS. 2, 3 and 4 show the initial stages of the use of the
device, prior to the performance of an injection. The assembled
safety device with the abutments 23 engaged behind the first
shoulders 31 of the sheath and held there by the force of spring 38
is disposed within a container 40 having a front wall 41 provided
with a central hole 42 which is a friction fit over the sheath 13
of the needle assembly 10. The rear end of the container 40 is
open, but may be closed by a strippable seal (not shown) and which
is removed immediately prior to use of the device. The injector 11
is prepared by fitting a sheathed needle assembly thereto, in an
entirely conventional manner. The injector and needle assembly are
then offered to the safety device (FIG. 2) and pushed fully into
the container 40 so that the sheath 13 projects through the central
hole 42 in the front wall 41 of the container 40; the holder 12 of
the needle assembly 10 is then fully received within the tubular
support 14, engaged with the lip 15 thereof.
[0045] The injector 11 is then pulled away from the container 40.
This leaves the sheath 13 frictionally engaged with the front wall
41 of the container 40, de-sheathing the needle 36 so as to be
ready for use. A significant length of the needle 36 is exposed
beyond the flange 34 at the forward end of the shield 25, whereby
the user may observe the injection site and use the pen injector in
essentially the same manner as if the safety device were not fitted
thereto. However, on performing the injection by pushing the pen
injector into the injection site, the needle 36, support 14 and
locking member 18 all move forwardly with respect to the shield
25--that is, the shield moves rearwardly with respect to the
injector 11. During the initial stage of this forward movement of
the injector, the pressure on the support 14 is transferred to the
locking member 18 through the interaction of the cam followers 22
bearing on the cam profiles 21, along with the rearward force of
the spring 38 also acting on the locking member. This serves to
rotate the locking member 18 to move the abutments 23 out of
alignment with the first shoulders 31 and into alignment with the
central part 29 of the respective slot 27. The fully forward
position (FIG. 6) is defined by the turns of the spring 38 binding;
in this position, the projections 17 of the support 14 are still
disposed within the central parts 29 of the slots 27.
[0046] On moving the injector 11 away from the injection site, the
support 14 and locking member 18 move rearwardly with respect to
the shield 25 under the action of spring 38. The support 14 moves
rearwardly until the abutments 23 reach the rearward ends of the
slots 27 (FIG. 7) but there is still a rearward spring force acting
on the locking member 18. This force in conjunction with the
interengaged cam profiles 21 and followers 22, serves to rotate the
locking member 18 yet further, to bring the abutments 23 thereof
behind the second shoulders 32 of the slots 27. If now rearward
pressure is applied to the shield 25, the support 14 and locking
member 18 cannot move forwardly within the shield, by virtue of the
interengagement of the abutments 23 with the second shoulders 32.
The shield is thus effectively locked in a protecting position
where the needle 36 is wholly covered by the shield 25.
[0047] Once locked as described above, the entire device may be
rotated to unscrew the holder 12 of the needle assembly 10 from the
injector 11, thus releasing the needle 36 which may remain
protected within the device. The combination of the device and
needle may then be disposed of in a safe manner, for example by
depositing that combination within a sharps container. As an
alternative, the entire device may be reinserted into the container
40 and the injector then unscrewed from the needle assembly, so
leaving the device within the container ready for disposal.
* * * * *