U.S. patent application number 14/584145 was filed with the patent office on 2015-06-25 for syringe safety assembly.
The applicant listed for this patent is UCB Pharma S.A.. Invention is credited to Alistair Bramley, Daniel Formosa, Eric Freitag, Anthony Torris.
Application Number | 20150174340 14/584145 |
Document ID | / |
Family ID | 46466930 |
Filed Date | 2015-06-25 |
United States Patent
Application |
20150174340 |
Kind Code |
A1 |
Torris; Anthony ; et
al. |
June 25, 2015 |
SYRINGE SAFETY ASSEMBLY
Abstract
Systems, devices, and methods are provided for providing safe
syringe assemblies for injections. The syringe assemblies include a
shielding mechanism that covers a syringe needle after an injection
is delivered, thereby reducing the risk of a subsequent accidental
stab from the needle. The shielding mechanism has a pre-injection
configuration in which the needle extends beyond the housing and a
post-injection configuration in which at least one component of the
syringe assembly covers the needle. In some implementations, the
syringe assembly includes a lock that inhibits the assembly from
returning to the pre-injection configuration once an injection is
delivered. The syringe assemblies may also include a bevel
orientation mechanism that allows a user to align a needle bevel to
accurately insert a needle for injection.
Inventors: |
Torris; Anthony; (Montclair,
NJ) ; Bramley; Alistair; (Brooklyn, NY) ;
Formosa; Daniel; (Piermont, NY) ; Freitag; Eric;
(Brooklyn, NY) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
UCB Pharma S.A. |
Brussels |
|
BE |
|
|
Family ID: |
46466930 |
Appl. No.: |
14/584145 |
Filed: |
December 29, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
13532382 |
Jun 25, 2012 |
8945065 |
|
|
14584145 |
|
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|
61500822 |
Jun 24, 2011 |
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Current U.S.
Class: |
604/110 ; 29/428;
604/198 |
Current CPC
Class: |
A61M 5/3137 20130101;
A61M 2005/3289 20130101; A61M 5/3232 20130101; A61M 2005/3264
20130101; A61M 5/3134 20130101; A61M 5/34 20130101; A61M 5/5066
20130101; A61M 5/3204 20130101; Y10T 29/49826 20150115; A61M 5/326
20130101; A61M 5/321 20130101; A61M 5/31573 20130101; A61M 2207/00
20130101 |
International
Class: |
A61M 5/32 20060101
A61M005/32; A61M 5/315 20060101 A61M005/315; A61M 5/31 20060101
A61M005/31; A61M 5/50 20060101 A61M005/50 |
Claims
1. A syringe assembly, comprising: a housing having a retaining
clip and an inner chamber with a first opening for receiving a
syringe and a second opening to allow a needle of the syringe to
extend beyond the housing; a first sheath positioned within the
housing; a spring that exerts a force biasing the housing in a
direction towards the second opening of the housing and biasing the
first sheath in a direction towards the first opening of the
housing; and a retainer that moves in a direction perpendicular to
the spring force to release the retaining clip upon actuation of
the syringe assembly.
2. The syringe assembly of claim 1, wherein the retaining clip is
static and does not move relative to the housing when the syringe
assembly is actuated.
3. The syringe assembly of claim 1, wherein the syringe assembly is
actuated by the depression of a plunger into the syringe.
4. The syringe assembly of claim 3, wherein the plunger contacts
the retainer and exerts a force that causes the retainer to move
perpendicular to the spring force.
5. The syringe assembly of claim 3, wherein: the plunger contacts
an intermediate actuator; and the intermediate actuator contacts
the retainer and exerts a force that causes the retainer to move
perpendicular to the spring force.
6. The syringe assembly of claim 1, wherein the syringe assembly
moves from an unshielded configuration to a shielded configuration
upon actuation of the syringe assembly and the first sheath
includes a locking mechanism that locks the housing and first
sheath in the shielded configuration and prevents the syringe
assembly from returning to the unshielded configuration.
7. The syringe assembly of claim 6, wherein the locking mechanism
comprises a shelf on the housing that contacts legs on the first
sheath.
8. The syringe assembly of claim 1, further comprising an outer top
at the first opening of the housing, wherein the first sheath is
held within the housing by the outer top.
9. The syringe assembly of claim 8, wherein the outer top is
configured to receive a syringe inserted into the syringe
assembly.
10. The syringe assembly of claim 9, wherein an opening of the
outer top is shaped to match a shape of a collar of an inserted
syringe.
11. The syringe assembly of claim 1, further comprising a second
sheath positioned within the housing.
12. The syringe assembly of claim 11, wherein the first sheath
includes a locking mechanism comprising legs on the first sheath
that contact a shelf on the second sheath.
13. The syringe assembly of claim 12, wherein the legs are angled
to allow the legs to deflect as the shelf passes the legs when the
first sheath and second sheath move from an unshielded
configuration to a shielded configuration and prevent subsequent
deflection, blocking the shelf from moving back past the legs once
the syringe assembly is in the shielded configuration.
14. The syringe assembly of claim 11, wherein the spring is
positioned at a top opening of the second sheath.
15. The syringe assembly of claim 11, wherein the spring contacts
the second sheath directly to exert a biasing force on the second
sheath.
16. The syringe assembly of claim 1, wherein the spring surrounds
at least a portion of a syringe inserted into the syringe
assembly.
17. The syringe assembly of claim 1, further comprising a top cover
coupled to the housing.
18. The syringe assembly of claim 1, wherein the syringe is
pre-filled with a dosage of medication.
19. The syringe assembly of claim 1, wherein the syringe is empty
and configured to be filled with medication by a user prior to
injection.
20. A method of making a syringe assembly, comprising: providing a
housing having a retaining clip, said housing having an inner
chamber with a first opening for receiving a syringe and a second
opening to allow a needle of the syringe to extend beyond the
housing; positioning a retainer to interact with the retaining
clip, wherein the retainer moves in a direction perpendicular to a
spring force to release the retaining clip upon actuation of a
syringe; placing a sheath within the housing; and positioning a
spring to exert a force biasing the housing in a direction towards
the second opening of the housing and biasing the sheath in a
direction towards the first opening of the housing.
21-38. (canceled)
39. A syringe assembly, comprising: a housing having an inner
chamber with a first opening for receiving a syringe and a second
opening to allow a needle of the syringe to extend beyond the
housing; a sheath positioned within the housing; a spring that
exerts a force biasing the housing in a direction towards the
second opening of the housing and biasing the sheath in a direction
towards the first opening of the housing; a locking mechanism that
resists the biasing force of the spring; and a plate that rotates
to release the locking mechanism upon actuation of the syringe
assembly.
Description
CROSS-REFERENCE TO RELATED APPLICATION
[0001] This application claims the benefit of U.S. Provisional
Application No. 61/500,822, filed Jun. 24, 2011, which is hereby
incorporated by reference herein in its entirety.
BACKGROUND
[0002] Many medical conditions require treatment that includes
medication administered through injections or infusions. Injections
are often administered on a regular schedule, and patients needing
regular injections often inject the medication themselves. Patients
may use conventional, single-use hypodermic syringes filled
manually using medication ampoules for injections, or medication
may be provided to a patient in single-use syringes that are
pre-filled with a correct dosage of the medication. In both
approaches, the syringes and needles used are disposed following a
single injection for safety and health concerns.
[0003] Handling and disposal of syringes is a safety concern for
both patients and medical professionals. Accidental stabs from
handling syringes and needles are a common problem and can cause
serious concerns for disease transmission. Typical syringes include
a sheath on the needle that a user must remove prior to an
injection and replace after the injection for disposal. Removal and
replacement of the sheath requires a user to place his or her
fingers in close proximity to an unshielded needle and can often
lead to an accidental stab. In addition, a sheath is often attached
to a syringe such that it will not fall off without a significant
amount of force applied by a user, and the force required may lead
to a slip and an accidental stab. After an injection is
administered, a user handling a syringe may accidentally stab
themselves while trying to re-shield or dispose of the used syringe
and needle.
[0004] In addition to the risk of accidental stabs, conventional
syringes may cause difficulties in inserting a needle at the
correct location and minimizing the amount of pain caused by
injections. Needles are provided with a bevel on the end of the
needle that creates a sharp pointed tip to increase the ease with
which the needle can be inserted into the skin. The sharp pointed
bevel allows a user to accurately target an injection site and
insert the needle in a way that reduces pain caused by the
insertion. Typical syringes include a needle that is attached to
the barrel of the syringe by a threaded attachment that does not
allow the needle to rotate. To orient the bevel of the needle, a
user may have to hold the syringe at an awkward angle and may have
difficulty effectively controlling the syringe and needle.
[0005] Elderly patients and patients afflicted with rheumatoid
arthritis may have difficulty safely handling and disposing of
syringes and needles. The small size of needle covers and the force
required to remove them can cause problems for patients who may be
weaker or may not have a level of dexterity necessary to safely
handle a syringe. In addition to creating an increased risk of
accidental stabs from needles, a patient's age or medical condition
may also make it more difficult to align a needle for an injection.
Patients suffering from arthritis or other joint afflictions may
find it painful or even impossible to orient the bevel of a syringe
properly for an injection.
[0006] More effective syringe systems are needed to address these
and other problems posed by currently available syringe systems.
There is a need for a syringe system that shields syringe needles
and protects a user after an injection is administered without
requiring a user to carefully replace a small cap on the needle.
There is also a need for syringe systems that facilitate
orientation of the needle bevel of a syringe to give accurate
injections and reduce patient pain.
SUMMARY
[0007] Described herein are systems, devices, and methods for
providing a syringe assembly that automatically shields a needle of
the syringe assembly after an injection is delivered. Also
disclosed herein are systems, devices, and methods for providing a
syringe assembly that allows a user to easily orient a needle and
needle bevel prior to delivery of an injection.
[0008] Systems, methods, and devices for a syringe safety assembly
are provided. An assembly contains a syringe for delivery of a
medication dose via injection. A shielding mechanism is included
that shields a syringe needle after an injection is delivered. A
syringe assembly has an unshielded configuration in which a needle
extends from the assembly and a shielded configuration in which a
needle does not extend from the assembly. A transition from an
unshielded configuration to a shielded configuration occurs when
the syringe assembly is actuated during delivery of an injection. A
locking mechanism locks the syringe assembly in the shielded
configuration and prevents the needle from being re-exposed from
the assembly.
[0009] Systems, methods, and devices for a syringe safety assembly
are provided. An assembly contains a syringe for delivery of a
medication dose via injection. A bevel orientation mechanism allows
a user to fully rotate the syringe and orient the bevel of a
syringe needle prior to injection. An assembly includes a bevel
orientation collar that can be actuated and rotated by a user. The
bevel orientation collar is coupled to a syringe within the
assembly either directly or indirectly, and rotation of the bevel
orientation collar rotates the syringe.
[0010] The systems, devices, and methods described herein provide
syringe assemblies that allow a user to administer a more efficient
and safe injection. In certain implementations, the syringe
assemblies accommodate a variety of different syringes, including
standard hypodermic syringes that may be filled from medication
ampoules by a user as well as pre-filled syringes that are provided
with a set dosage of medication already loaded into the syringe. A
syringe assembly may be provided with a syringe already included in
the assembly, or may be provided as a shell into which a syringe
can be placed by a user.
[0011] The syringe assemblies described herein include a shielding
mechanism that shields a syringe needle after an injection is
delivered to a patient. The shielding mechanism is triggered when a
patient delivers an injection and deploys a shield that covers the
needle as it is removed from the injection site. The mechanism may
lock the assembly in the shielded configuration with the needle
covered so that further pressure applied by a user does not
re-expose the needle. With the needle shielded, the syringe
assembly may be safely handled until the syringe and needle are
carefully disposed. The entire assembly may also be disposable.
[0012] In certain embodiments, a syringe assembly includes a
housing with one or more retaining clips and a retainer. The
housing includes an inner chamber with an opening for receiving a
syringe and an opening for allowing a needle of the syringe to
extend beyond the housing. A syringe placed into the housing may be
pre-filled with a set dosage of medication or may be empty and
filled with medication by a user prior to injection. A sheath is
positioned within the housing, along with a spring that biases the
housing towards one opening of the housing and biases the sheath
towards another opening of the housing. The syringe assembly may be
in an unshielded configuration with a needle exposed or a shielded
configuration with the needle guarded within the housing. Actuation
of the syringe assembly, for example, by delivery of an injection,
causes the retainer to move in a direction perpendicular to the
biasing spring force and release the retaining clips. The
components of the assembly move from an unshielded configuration to
a shielded configuration upon release of the retaining clips. In
certain embodiments, a syringe assembly includes a top cover
coupled to the housing.
[0013] In certain embodiments, retaining clips of a syringe
assembly are provided as static components. The retaining clips
extend from a housing and do not move relative to the housing
during activation of the syringe assembly or during movement of
components from an unshielded configuration to a shielded
configuration. The movement from an unshielded to a shielded
configuration may occur during delivery of an injection, and may be
caused by the depression of a plunger into the syringe assembly.
The plunger interacts with internal components of the syringe
assembly to trigger the transition, and exerts force on a retainer
that causes the retainer to move perpendicular to a longitudinal
axis of an inner chamber of a housing to release the shielding
mechanism. In certain embodiments, the plunger does not contact the
retainer directly but contacts an intermediate actuator, which
contacts and exerts a force on the retainer to cause the retainer
to move perpendicular to a longitudinal axis of an inner chamber of
a housing.
[0014] In certain embodiments, a syringe assembly includes a
locking mechanism that prevents a syringe assembly from returning
to an unshielded configuration once it has transitioned to a
shielded configuration. A sheath is positioned within the housing
of a syringe assembly and includes a locking mechanism that locks
the housing and sheath in the shielded position. The locking
mechanism may include a shelf on the housing that contacts legs on
the sheath. In some embodiments, a syringe assembly includes first
and second sheaths held within a housing. A lockout mechanism may
include legs on the first sheath that contact a shelf on the second
sheath. The legs may be compliant to allow the shelf to pass the
legs when the first sheath and second sheath move from an
unshielded configuration to a shielded configuration, and may be
rigid to prevent the shelf from moving back past the legs once the
assembly is in the shielded configuration.
[0015] In certain embodiments, a syringe assembly includes an outer
top at a first opening of a housing, with a sheath held within the
housing by the outer top. The outer top may be configured to
receive a syringe inserted into the syringe assembly, and may have
an opening shaped to match a shape of a collar on an inserted
syringe.
[0016] In certain embodiments, the spring of a syringe assembly is
positioned at a top opening of a sheath of the assembly. The spring
may contact an interior sheath of the assembly directly to exert a
biasing force on the sheath. The spring may be positioned around an
interior chamber of a syringe assembly housing, and may surround a
portion of a syringe inserted into the syringe assembly.
[0017] The syringe assemblies described herein may include a
mechanism that facilitates orientation of a needle bevel for an
injection. In certain implementations, internal components of a
syringe assembly and a syringe held by the syringe assembly are
configured to rotate independent of the outer housing. A
user-actuatable component provides an easy way for a user to turn
the needle and orient the syringe within the syringe assembly and
the bevel of the needle extending from the syringe assembly.
[0018] In certain embodiments, a syringe assembly with a bevel
orientation mechanism includes a housing having an inner chamber
with a first opening for receiving a syringe and a second opening
to allow a needle of a syringe to extend beyond the housing. The
assembly includes a collar coupled to the second opening of the
housing. Rotation of the collar relative to the housing drives
rotation of a syringe inserted into the syringe assembly. In
certain implementations, the collar is an independent component
that can be separated from the housing. A user rotates the collar,
for example, in a 360 degree rotation, to orient a needle bevel for
an injection. In some embodiments, the collar directly contacts a
syringe held within the syringe assembly and causes the syringe to
rotate when the collar is rotated. In some embodiments, a holding
component is positioned within the collar to operatively couple the
collar to a syringe inserted into the syringe assembly. In certain
embodiments, a collar is releasably coupled to a pull cap that
covers a needle of a syringe assembly.
[0019] In certain embodiments, a syringe assembly with a bevel
orientation mechanism includes a first sheath positioned within a
housing. The first sheath may be coupled to a collar attached to
the housing. The first sheath may include clips that are configured
to mate with pockets on the collar to operatively couple the first
sheath and the collar. The clips may be configured to be releasable
to allow the sheath to move along a longitudinal axis of the inner
chamber of the housing.
[0020] In certain embodiments, a syringe assembly with a bevel
orientation mechanism includes a first sheath and a second sheath
operatively coupled to the first sheath. The second sheath is
configured to receive a syringe inserted into the syringe assembly.
The syringe assembly may also include an outer top coupled to the
second sheath, and the outer top may be shaped to match a shape of
a collar of an inserted syringe. The syringe assembly may also
include an inner housing that holds the second sheath within the
housing of the syringe assembly. The inner housing preferably does
not rotate relative to the housing, but may allow the second sheath
and outer top to rotate relative to the housing. The inner housing
may have at least one cutout that holds the outer top and allows
rotation of the outer top while the inner housing remains static.
Rotation of the collar may cause rotation of the inner sheath,
outer sheath, and a syringe inserted into the syringe assembly
relative to the housing.
[0021] In certain embodiments, a syringe assembly includes a
housing having an inner chamber with a first opening for receiving
a syringe and a second opening to allow a needle of the syringe to
extend beyond the housing, with a sheath positioned within the
housing. A spring exerts a force biasing the housing in a direction
towards the second opening of the housing and biasing the sheath in
a direction towards the first opening of the housing. A locking
mechanism resists the biasing force of the spring, and a plate
rotates to release the locking mechanism upon actuation of the
syringe assembly.
[0022] In certain embodiments, a syringe assembly includes an inner
sheath having a first opening and an inner chamber for receiving a
syringe, and an outer housing having a second opening to allow a
needle of the syringe to extend beyond the housing. A spring exerts
a force biasing the sheath in a direction towards the first opening
and biasing the housing in a direction towards the second opening.
A locking mechanism resists the biasing force of the spring, and an
activating member moves in a direction towards the second opening
to release the locking mechanism upon actuation of the syringe
assembly.
BRIEF DESCRIPTION OF THE DRAWINGS
[0023] The foregoing and other objects and advantages will be
appreciated more fully from the following further description
thereof, with reference to the accompanying drawings. These
depicted embodiments are to be understood as illustrative and not
as limiting in any way:
[0024] FIG. 1 shows a perspective view of an illustrative syringe
assembly;
[0025] FIG. 2 shows a front view of an illustrative syringe
assembly in an unshielded configuration;
[0026] FIG. 3 shows a front view of an illustrative syringe
assembly in a shielded configuration;
[0027] FIG. 4 shows a cross-section of an illustrative syringe
assembly;
[0028] FIG. 5 shows a cross-section of an illustrative syringe
assembly during delivery of an injection:
[0029] FIG. 6 shows a cross-section of an illustrative syringe
assembly after an injection has been delivered;
[0030] FIGS. 7 and 8 show a cross-sections of an illustrative
syringe assembly in a shielded configuration;
[0031] FIGS. 9-11 show internal lockout components of an
illustrative syringe assembly;
[0032] FIG. 12 shows a perspective view of internal bevel
orientation components of an illustrative syringe assembly;
[0033] FIG. 13 shows a cross section of bevel orientation
components of an illustrative syringe assembly;
[0034] FIG. 14 shows a perspective view of an illustrative syringe
assembly;
[0035] FIGS. 15 and 16 show perspective views of internal
components of an illustrative syringe assembly;
[0036] FIGS. 17-23 show illustrative steps of an assembly process
for a syringe assembly;
[0037] FIG. 24 shows an illustrative syringe assembly;
[0038] FIG. 25 shows engaging and rotating plates of the syringe
assembly shown in FIG. 24:
[0039] FIG. 26 shows a release slot of the syringe assembly shown
in FIG. 25;
[0040] FIG. 27 shows a portion of the syringe assembly shown in
FIG. 24 during an injection;
[0041] FIG. 28 shows the engaging and rotating plates shown in FIG.
25 during an injection;
[0042] FIG. 29 shows the release slot shown in FIG. 26 during an
injection;
[0043] FIG. 30 shows the syringe assembly shown in FIG. 24 after an
injection;
[0044] FIG. 31 shows an illustrative syringe assembly;
[0045] FIG. 32 shows a triggering mechanism of the syringe assembly
shown in FIG. 31;
[0046] FIG. 33 shows the syringe assembly shown in FIG. 31 after an
injection;
[0047] FIG. 34 shows an illustrative triggering mechanism;
[0048] FIG. 35 shows the triggering mechanism shown in FIG. 34
after an injection;
[0049] FIG. 36 shows an illustrative triggering mechanism; and
[0050] FIG. 37 shows the triggering mechanism shown in FIG. 36
after an injection.
DETAILED DESCRIPTION
[0051] To provide an overall understanding of the systems, devices,
and methods described herein, certain illustrative embodiments will
now be described. For the purpose of clarity and illustration, the
systems and methods will be described with respect to a shielding
assembly for pre-filled syringe cartridges. It will be understood
by one of ordinary skill in the art that the systems and methods
described herein may be adapted and modified as is appropriate, and
that the systems and methods described herein may be employed in
other suitable applications, such as for other types of syringes or
injectors, and that such other additions and modifications will not
depart from the scope hereof.
[0052] FIGS. 1 and 2 show a syringe assembly 100 according to
certain embodiments. The syringe assembly 100 includes a plunger
102, a housing 104 with a top cover 106, a bevel orientation collar
108, and a pull cap 110. The housing 104 has an inner chamber
configured to receive a pre-filled syringe that contains a set
dosage of a medication. To deliver an injection using the syringe
assembly 100, a user can grab the handles 112 of the housing 104,
remove the pull cap 110, turn the bevel orientation collar 108 to
orient the bevel of the syringe needle 114, insert the needle 114
into an arm or any other location, and deliver the injection by
depressing the plunger 102 down toward the housing 104.
[0053] The syringe assembly 100 is configured to allow a syringe to
rotate freely within the housing 104. This full rotation allows the
user to orient the bevel of the needle 114 in any desired
orientation, which can increase the convenience of use and allow
the user to deliver a more painless injection. To orient the bevel,
a user rotates the bevel orientation collar 108 while holding on to
the handles 112 of the syringe assembly 100. The bevel orientation
collar 108 is coupled to the syringe contained within the housing
104, either directly or indirectly, via internal components of the
syringe assembly 100. Rotation of the bevel orientation collar 108
causes the syringe held within the housing 104 to rotate and allows
the user to orient the bevel in any desired orientation.
[0054] The syringe assembly 100 also contains a shielding mechanism
that shields the needle 114 and protects the user after an
injection is delivered. When the plunger 102 is fully depressed to
deliver the injection, it activates the internal shielding
mechanism of the syringe assembly 100. In certain embodiments, the
shielding mechanism causes internal components of the housing 104
and a syringe held within the housing 104 to move upward,
withdrawing the needle 114 into the housing 104. With the needle
114 withdrawn into the housing 104, the user is shielded from the
needle 114 as shown in FIG. 3. The shielding mechanism may also
include a lock that locks the syringe assembly 100 in the shielded
configuration and prevents the needle 114 from being pushed back
out of the housing 104. With the syringe assembly 100 in this
shielded configuration, the syringe can be handled and disposed
without risking a second stick of the needle 114 to the
patient.
[0055] The transition from the unshielded configuration to the
shielded configuration of the syringe assembly 100 begins when a
user administers an injection. During the injection, the plunger
102 interacts with internal components of the syringe assembly 100
to unlock and trigger the needle shielding mechanism. FIG. 4 shows
a cross-section of an upper portion of the syringe assembly 100
revealing internal triggering components that hold the syringe
assembly 100 in the unshielded configuration. This view shows the
housing 104, top cover 106, and plunger 102, as well as internal
components that are part of the needle shielding mechanism. The
interior components include a retainer 116, a spring 118, an inner
sheath 120, an outer sheath 122, a syringe barrel 124, an inner
housing 126, and an outer top 128. When the interior components are
configured as shown in FIG. 4, the syringe is in the unshielded
configuration, and the needle 114 at the lower end of the syringe
barrel 124 is exposed from the housing 104 for an injection.
[0056] When the syringe assembly 100 is in the unshielded
configuration shown in FIG. 4, the spring 118 is in a compressed
state. The compressed spring 118 exerts a force on the outer top
128, biasing the outer top 128 upward in the direction of arrows
176, and exerts a force on the inner sheath 120, biasing the inner
sheath 120 downward in the direction of arrows 178. Shoulders 130
on the upper end of the inner sheath 120 contact shoulders 132 on
the housing 104 and prevent the force of the spring 118 from moving
the inner sheath 120 downward. Clips 134 on the outer top 128
contact shoulders 136 on the outer sheath 122 and prevent the force
of the spring 118 from moving the outer top 128 upward.
[0057] The retainer 116 and retaining clips 138 hold the syringe
assembly 100 in the unshielded configuration. In particular, the
retaining clips 138 extend upward from an inner surface of the
housing 104 and, as shown in FIGS. 4-6, latch on to the retainer
116 and resist the force of the spring 118. A platform section 180,
shown in FIG. 6, on each of the lateral ends 140 of the retainer
116 fits under and interacts with an undercut portion 182 of each
retaining clip 138. This interaction between the platform sections
180 on the retainer 116 and the undercut portions 182 on the
retaining clips 138 prevents the spring 118 from forcing the inner
sheath 120 and housing 104 downward and from forcing the outer
sheath 122, inner housing 126, outer top 128, retainer 116 and top
cover 106 upward. In certain embodiments, the retaining clips 138
are static and are not deflected by interaction with the retainer
116 or any other interior components of the syringe assembly 100.
The retaining clips 138 may remain static and undeflected
throughout delivery of an injection, triggering of the shielding
mechanism, and movement of the assembly components during the
transition from an unshielded configuration to a shielded
configuration.
[0058] When the plunger 102 is depressed to deliver an injection,
the downward driving motion of the plunger 102 releases the
resistance provided by the interaction between the retainer 116 and
the retaining clips 138, triggering the needle shielding mechanism.
More particularly, as shown in FIG. 5, the head 142 of the plunger
102 has a curved undersurface 144 that contacts the retainer 116,
indirectly or directly, and exerts a downward force on the retainer
116 in the direction of arrows 166. As the plunger 102 is depressed
into the syringe barrel 124, bent portions 146 of the retainer
straighten, thereby flattening retainer 116 and pushing the ends
140 of the retainer 116 laterally in the direction shown by arrows
164. The force exerted by the depressed plunger head 142 during
injection thus causes the ends 140 of the retainer 116 to move
laterally due to the geometry of the retainer 116, releasing the
hold on the retaining clips 138 and allowing the inner syringe
assembly components to spring into the shielded configuration.
[0059] An intermediate actuator, such as actuator 238 discussed
below with respect to FIG. 23, may be used in the syringe assembly
100 to trigger the release of the retaining clips 138 when the
plunger 102 is depressed. The actuator would interact with both the
plunger 102 and a retaining member that holds onto the retaining
clips 138. When the plunger 102 is depressed, it exerts a force on
the actuator that is transferred to the retaining member and causes
the retaining member to release the retaining clips 138. Depending
on the inner configuration and geometry of a syringe assembly, an
intermediate actuator may be preferred and may simplify the
manufacturing process for the syringe assembly by allowing a
retainer to be easily positioned to hold the retaining clips 138
before the actuator is inserted into the assembly and covered.
[0060] The release of retaining clips 138 by retainer 116 is shown
in FIG. 6, which shows the retainer 116 and retaining clips 138
after the plunger 102 has been fully depressed, the retainer 116
has flattened, and the ends 140 of the retainer 116 have moved
laterally. Once the retainer 116 and retaining clips 138 are in
this configuration, there is no longer adequate resistance to
overcome the forces of the spring 118. As a result, once the user
releases pressure on the head 142 of the plunger 102, the spring
118 will extend, forcing the housing 104 and inner sheath 120 in a
downward direction and forcing the top cover 106, retainer 116,
inner housing 126, outer top 128 and outer sheath 122, along with
the syringe barrel 124, in an upward direction.
[0061] The upward movement of the syringe barrel 124 caused by the
force exerted by the spring 118 withdraws the needle 114 into the
housing 104. When the spring 118 is fully extended, the syringe
assembly 100 is in the completely shielded configuration shown in
FIG. 7. In this configuration, the needle 114 is now covered by the
housing 104, the inner sheath 120, and the bevel orientation collar
108. For safety, the user may not be able to push the needle 114
back out of the syringe assembly 100. This covering helps ensure
that the user does not accidentally stab herself a second time
after an injection is given. The shield also protects others, such
as medical professionals, from accidental stabs and reduces the
risk of disease transmission from the used needle 114.
[0062] The relative movement of the exterior housing 104 of the
syringe assembly 100 with respect to the internal components
shields the needle 114. FIG. 8 shows a cross-section of the syringe
assembly 100 in the shielded configuration. The outer sheath 122,
outer top 128, and inner housing 126 have moved upward away from
the housing 104 and the inner sheath 120, pulling with them the
syringe barrel 124 and attached needle 114. In this configuration,
the user is now protected from the shielded needle 114.
[0063] Following an injection, a lockout mechanism of the syringe
assembly 100 prevents the needle 114 from being re-exposed once the
syringe assembly 100 is in the shielded configuration shown in
FIGS. 7 and 8. In certain embodiments, the lockout may be caused by
interaction between at least two of the components of the syringe
assembly 100. For example, the lockout mechanism may be an
interaction by the outer sheath 122 and the housing 104 or an
interaction between the inner sheath 120 and the outer sheath
122.
[0064] According to certain embodiments, the syringe assembly 100
is locked in the shielded configuration by an interaction between
the inner sheath 120 and outer sheath 122 components as they move
relative to each other when the spring 118 extends. FIG. 9
illustrates an example of a lockout mechanism of this type. As
shown, the syringe assembly 100 is in the unshielded configuration,
with the housing 104 removed. The lockout mechanism includes the
shelf 148 of the inner sheath 120 and the legs 150 of the outer
sheath 122. When an injection is delivered and the shielding
mechanism is triggered, the force of the spring 118 causes the
inner sheath 120 to move downward and the outer sheath 122 to move
upward, thus causing the shelf 148 to move towards the legs 150. As
the injection is delivered, the shelf 148 and legs 150 come into
contact as shown in FIG. 10. The inner surfaces of the legs 150
contact the sloped outer surfaces of the shelf 148. In certain
implementations, the legs 150 are made of a compliant plastic, such
as a polyethylene material. Due to their geometry and the compliant
material, the legs 150 of the outer sheath 122 deflect as the shelf
148 of the inner sheath 120 passes the legs 150. The deflection
occurs, for example, in the direction of arrow 160.
[0065] As shown in FIG. 11, after the shelf 148 passes the legs 150
as the spring 118 continues to extend, the legs 150 return to their
original configuration, completing the lockout mechanism. In
particular, the lower face of each leg 150 rests on top of the top
surface of the shelf 148 after returning to their original
configuration. The interaction between the legs 150 and the shelf
148 in the shielded configuration of the syringe assembly 100
prevents the shelf 148 from moving back towards the upper end of
the syringe assembly 100 and therefore prevents movement of the
outer sheath 122 downward past the shelf 148 and the inner sheath
120. Because the legs 150 are angled, they do not deflect further
as would be needed for the legs 150 to pass back over the shelf
148. The interaction between the outer sheath 122, inner housing
126, outer top 128, and the upper end of the syringe barrel 124,
shown in FIG. 4, pulls the needle 114 into the housing 104 as the
legs 150 of the outer sheath 122 brace against the shelf 148 of the
inner sheath 120 prevents the syringe from moving downward back
through the inner sheath 120 and housing 104. With the components
of the syringe assembly 100 locked in this configuration, the
needle 114 is shielded from the patient and cannot be pushed back
out beyond the housing 104 by further pressure on the plunger 102
applied by the user.
[0066] The needle shielding and locking mechanisms discussed above
with respect to FIGS. 1-11 are merely illustrative, and alternative
triggering and shielding mechanisms may be employed in some
embodiments. For example, FIG. 24 shows an embodiment of a syringe
assembly with a needle shielding mechanism that employs a
triggering and shielding feature that differs from the syringe
assemblies shown in FIGS. 1-11. In FIG. 24, a syringe assembly 300
is shown in a pre-injection configuration. An outer housing 302
holds a syringe 313 adapted to deliver an injection through needle
314. The syringe assembly 300 includes an inner housing 304 that is
biased in a proximate direction from the outer housing 302 by two
springs 306a and 306b. When an injection is delivered by depression
of the plunger 316, an engaging plate 308 causes a rotating plate
308 to turn and triggers a shielding mechanism that retracts the
syringe 313 and inner housing 304 proximately so that needle 314 is
covered by a distal end 318 of the outer housing 302.
[0067] In the pre-injection configuration shown in FIG. 24, the
springs 306a and 306b are compressed. The compressed springs exert
a proximal force on the inner housing 304 and a distal force on the
outer housing 302, thus biasing the two housings apart from each
other. Spring 306a contacts the inner housing 304 at surface 322a,
while spring 306b contacts the inner housing 304 at surface 322b.
Likewise, the spring 306a contacts the outer housing 302 at surface
324a, and the spring 306b contacts the outer housing 302 at surface
324b. The contact between the springs and these surfaces produces
the biasing force on the inner housing 304 and outer housing 302.
The biasing forces from the springs are resisted in the
pre-injection configuration by a locking mechanism on the engaging
plate 308 and the rotating plate 308. The engaging plate 308 has
two locking tabs 326a and 326b, while the rotating plate 308 has
two locking tabs 328a and 328b. Before an injection is delivered,
the locking tabs are disposed in a release slot that is disposed in
walls 330a and 330b of the inner housing and walls 332a and 332b of
the outer housing. The interaction between the locking tabs and the
release slots, discussed below with respect to FIGS. 25 and 26,
creates the triggering mechanism that releases the inner housing
304 and outer housing 302 to shield the needle 314 after an
injection is delivered.
[0068] FIG. 25 shows the engaging plate 308 and the rotating plate
310 in the pre-injection configuration shown in FIG. 24. In this
configuration, the two plates are separated by a distance D, and
the locking tab 326a is offset from the locking tab 328a in the
direction shown by arrow 340. The locking tabs 326a and 328a extend
radially outward from the plates and into release slots in the
inner housing 304 and outer housing 302. FIG. 26 shows the release
slot 334 in which the locking tabs 326a and 328a are disposed.
[0069] As shown in FIG. 26, the offset between the locking tabs
326a and 328a is caused by the position of the locking tabs into
two different arms 342 and 346 of the release slot 334. The arm 342
forms a corner 344 that contacts the locking tab 328a to resist the
biasing forces of the springs 306a and 306b. The proximal biasing
force of the springs pushes the inner housing 304 and the rotating
plate 308 upwards in the direction of arrow 348 in FIG. 26, but the
locking tab 328 contacts the corner 344 of the outer housing 302
and resists the proximal biasing force of the springs.
[0070] From the pre-injection configuration shown in FIG. 24, an
injection is delivered by depressing the plunger 316 in the distal
direction shown by arrow 350. As the plunger is depressed, a lower
surface 320 of the plunger head 352 enters the outer housing 302
and contacts the engaging plate 308, as shown in FIG. 27. The
contact between the surface 320 and the engaging plate 308 pushes
the engaging plate distally until it contacts the rotating plate
310. When the engaging plate 308 moves to close the distance D
between the plates, a sloped surface 356 of the engaging plate 308
contacts a corresponding sloped surface 354 of the rotating plate
310. The distal force applied to the plunger head 352 in the
direction of arrow 350 causes the rotating plate 310 to turn in the
direction of arrow 340 shown in FIG. 25. The rotation is created by
the interaction between the sloped surface 356 of the engaging
plate 308 and the sloped surface 354 of the rotating plate 310. The
rotating plate 310 continues to turn until a corner 358 contacts a
corresponding corner 360 on the engaging plate 308. When the
injection is delivered and the rotation is complete, the locking
tabs 326a and 328A are aligned in the post-injection configuration
shown in FIG. 28.
[0071] In the post-injection configuration, the locking tabs 326a
and 328a are aligned in the release slot 334 in the configuration
shown in FIG. 29. In this configuration, the locking tab 328a of
the rotating plate 310 has moved down arm 342 in the direction of
arrow 366 and slightly past the corner 364 that connects the arms
342 and 346. From this position, the locking tab 328a is positioned
to move up the second arm 346 in the direction of arrow 362 when
the distal injection force is released from the plunger head 352.
Thus, the force that delivers an injection from the syringe 313
also unlocks the shield locking mechanism of the syringe assembly
300.
[0072] With the tab 328a positioned to move up the second arm 346
of the release slot 334, the contact between the tab 328a and the
corner 344 that holds the springs 306a and 306b in their compressed
state is released. As a result, after the injection, the two
springs extend and separate the inner house 304 and outer housing
302, as shown in FIG. 30. In this shielded configuration, the
delivery of the injection is complete and the springs 306a and 306b
have fully extended. This extension pushes the inner housing 304
proximally out of the outer housing 302 in the direction shown by
arrow 368. As a result, the needle 314 connected to the syringe is
withdrawn into the outer housing 302. The lower end 318 of the
outer housing 302 now shields the needle and decreases the risk of
accidental stab from the needle 314. The assembly 300 may include a
locking mechanism, such as the locking mechanism discussed above
with respect to FIGS. 1-11, that locks the inner housing 304 and
outer housing 302 in the shielded configuration and prevents the
needle 314 from being pushed distally past the lower end 318 of the
housing.
[0073] The syringe shields shown in FIGS. 1-30 employ a retraction
shielding mechanism that withdraws a syringe proximately into a
syringe housing when the mechanism is triggered. When the syringe
is retracted proximately, the needle is withdrawn into the housing,
which remains stationary and shields the needle after injection. In
addition to these retraction shielding mechanisms, certain syringes
may employ a forward shielding that extends a shield forward past
the housing and over a needle rather than withdrawing the syringe
and needle into the housing.
[0074] A forward shielding syringe assembly 400 is shown in FIG.
31. The assembly 400 includes a housing 402 that receives a syringe
404 adapted to deliver an injection. Within the housing 402 is an
inner sheath 410 that interacts with an outer sheath 412 to form
the mechanism that shields the needle 406 after the plunger 408 is
depressed in the direction shown by arrow 420 to deliver an
injection from the syringe 404. Two springs 414a and 414b bias the
inner sheath 410 and outer sheath 412 in opposite directions. The
compressed springs exert a proximal force on the inner sheath 410
that pushes the inner sheath towards the plunger 408 and exerts a
distal force on the outer sheath 412 that biases the outer sheath
toward the needle 406. To resist these biasing forces, platforms
422a and 422b of the inner sheath 410 contact clips 424a and 424b
of the outer sheath 412. The contact between the platforms and
clips resists the force exerted on the inner sheath 410 and the
outer sheath 412 by the compressed springs 414a and 414b when the
assembly 400 is in the pre-injection configuration shown in FIG.
31.
[0075] When an injection is delivered, the interaction between the
platforms 422a and 422b and the clips 424a and 424b is interrupted
by activating members 416a and 416b of the syringe assembly 400.
When the plunger 408 is depressed to deliver an injection, a lower
surface 418 of the plunger contacts the activating members 416a and
416b and transfers the distal force of the injection to the
activating members. Each of the activating members 416a and 416b
then contacts one of the clips 424a and 424b, respectively, and
pushes the clips outwards in the directions shown by arrow 426 and
428. A close-up view of this activation is shown in FIG. 32. When
the activating member 416b is pressed downward by the plunger 408,
a lower end 432 of the activating member 416b contacts the clip
424b and causes the clip to move outward in the direction of arrow
428. A sloped surface 434 on the end 432 contacts a corresponding
sloped surface 436 on the clip 424b such that the downward motion
of the activating member 416b pushes the clip 424b outwards. When
the clip is pushed outwards to the position shown in FIG. 32, there
is no longer an interaction between the platform 422b and clip 424b
to resist the biasing forces of the spring 414b. Thus, in this
configuration, the outer sheath 412 is free to move distally in the
direction of arrow 430 as the spring 414b extends.
[0076] The distal movement of the outer sheath 412 shields the
needle 406 in the post-injection configuration of the assembly 400,
shown in FIG. 33. After the injection is delivered, the triggering
mechanism is released, and the springs 414a and 414b extend. The
outer sheath 412 is pushed distally until platforms 423a and 423b
of the outer sheath contact distal clips 438a and 438b of the inner
sheath 410. The contact between the platforms and the distal clips
resists any further movement of the outer sheath 412. In this
configuration, the needle 416 is covered by a distal end 440 of the
outer sheath 412. In addition to the triggering and forward
shielding mechanism of the assembly 400, the assembly may include a
locking mechanism that locks the outer sheath 412 in the position
shown in FIG. 33 and resists movement of the outer sheath back in
the proximal direction. Such a locking mechanism reduces the risk
of an accidental stab of needle 406 by preventing the needle from
being pushed back out past the lower end 440 of the outer sheath
412 from the shielded configuration.
[0077] In addition to the platform and clip interaction shown in
assembly 400, other triggering mechanisms may be employed in a
forward shielding syringe assembly. For example, FIG. 34 shows a
triggering mechanism that uses an over center cam 448 and an
activating member 444.
[0078] In the pre-injection state shown in FIG. 34, an outer sheath
442 is biased distally by a compressed spring 446. The biasing
force of the spring 446 is resisted by the interaction between a
corner 452 of the cam 448 and a corner 454 of the outer sheath 442.
In this pre-injection configuration, the interaction between the
two corners prevents the outer sheath 442 from moving distally
under the force of the spring 446. When an injection is delivered,
the activating member 444, similar to activating members 416a and
416b shown in FIG. 31, moves distally and contacts the cam 448.
This contact causes the cam to rotate to the orientation shown in
FIG. 35.
[0079] In the post-injection configuration shown in FIG. 35, cam
448 is rotated in a counterclockwise direction relative to the
pre-injection configuration. After rotation the corner 452 of the
cam 448 is clear of the corner 454 of the outer sheath 442. Thus,
the two corners no longer interact to resist the biasing force of
spring 446. The outer sheath 442 is free to move distally in the
direction of arrow 450 under the force applied by the spring 446.
As a result of this distal movement, the outer sheath 442 is able
to move and cover a distal needle, similar to the needle 406 shown
in FIG. 33.
[0080] Another embodiment of a forward shielding triggering
mechanism is shown in FIGS. 36 and 37. In FIG. 36, an outer sheath
460 is under a biasing force from a compressed spring 462. The
distal biasing force is resisted by a head 476 of an inner sheath
458. The head 476 is larger than the width of the rest of the inner
sheath 458 and includes a back portion 478 that extends into a
pocket 474 of the outer sheath 460. In this position, a surface 466
of the inner sheath contacts a corresponding surface 464 of the
outer sheath and prevents the outer sheath from traveling past the
head 476, thus resisting the biasing force of the spring 462. The
interaction of the two sloped surfaces 464 and 466 pushes the head
476 forward in the direction of arrow 480. Movement in this
direction, however, is restricted by the interaction between
surface 468 of an activating member 456 and a front surface 470 of
the head 476. During an injection, the activating member 456 moves
distally, similar to the activating members 416a and 416b,
discussed above with respect to FIG. 31. The movement of the
activating member 456 aligns the pocket 472 of the activating
member in position to receive the head 476. As shown in FIG. 37,
once the pocket 472 reaches the head 476, the forward force created
by the interaction of surfaces 464 and 466 pushes the head 476 into
the pocket 472. In this configuration, the outer sheath 460 is free
to move distally in the direction of arrow 482. The spring 462 is
able to extend, moving the outer sheath 460 distally and covering a
distal needle, as discussed above with respect to FIG. 33.
[0081] As described in the above embodiments, a syringe assembly
that includes a needle shielding mechanism can provide for safer
handling of used needles. A shielding mechanism can trigger
automatically when an injection is delivered and shield a needle
after injection to protect a user against accidental stabs with a
used needle. Additional features may also be provided to enhance
the ease of use and convenience of the syringe assembly for a user.
One such feature is a bevel orientation mechanism that allows a
user to orient a needle bevel prior to delivering an injection
using the syringe assembly.
[0082] In certain embodiments, a bevel orientation mechanism is
included with the syringe assembly 100. As shown in FIGS. 12-16,
the bevel orientation collar 108 rotates around the syringe barrel
124 of the syringe to allow the user to adjust the angle at which
the bevel of the syringe needle is oriented prior to injection. The
interaction between the bevel orientation collar 108 and the
syringe barrel 124 may be either direct or indirect, through one or
more other intermediate components of the syringe assembly 100. In
some embodiments, an inner surface of the bevel orientation collar
108 contacts the syringe barrel 124 and causes it to rotate. In
some embodiments, intermediate interactions between internal
components of the syringe assembly 100 may translate rotation of
the bevel orientation collar 108 into rotation of the syringe
barrel 124. For example, a holding component, such as a rubber ring
gasket, may be positioned between the bevel orientation collar 108
and the syringe barrel 124. Rotation of the bevel orientation
collar 108 would rotate the gasket and syringe barrel 124 held
within the syringe assembly 100.
[0083] FIGS. 12-16 show an indirect rotational coupling between
components of syringe assembly 100 that are configured to provide a
bevel orientation mechanism, according to certain embodiments. In
the interaction depicted in FIGS. 12-16, the bevel orientation
collar 108 does not directly contact or rotate the syringe barrel
124. Rather, the rotation of the bevel orientation collar 108
rotates other internal components of the syringe assembly 100,
including the inner sheath 120, the outer sheath 122, and the outer
top 128, through internal connections and couplings between the
components. The internal components hold a syringe barrel in the
syringe assembly, and rotation of these components causes the
barrel to rotate. When the syringe barrel is rotated, the needle
attached to the barrel can be oriented by a user at any desired
angle.
[0084] FIG. 12 shows the lower end of the syringe assembly 100 with
the pull cap 110, bevel orientation collar 108, and housing 104
removed, exposing the inner sheath 120 and outer sheath 122. A
portion of the inner sheath 120, including clips 152, is not
covered by the outer sheath 122. The clips 152 are configured to
snap into notches on the bevel orientation collar of the syringe
assembly 100 when the bevel orientation collar is placed onto the
syringe assembly 100.
[0085] FIG. 13 shows a cross-section of the lower end of the
syringe assembly 100 with the bevel orientation collar 108
attached. The clips 152 of the inner sheath 120 snap into the
notches 154 of the bevel orientation collar 108 and thus couple the
inner sheath 120 to the bevel orientation collar 108. As a result
of this coupling, the inner sheath 120 rotates whenever a user
manually rotates bevel orientation collar 108.
[0086] FIGS. 14 and 15 depict one way that rotation of components
of the syringe assembly 100 occurs when a user manually rotates the
bevel orientation collar 108. As shown, the shelf 148 of the inner
sheath 120 extends outward through a slot 156 in the outer sheath
122. The shelf 148 creates a rotational coupling between the inner
sheath 120 and the outer sheath 122 by exerting a force on edges
158 of the slot 156 in the outer sheath 122 whenever the inner
sheath 120 is rotated. The force exerted on edges 158 by the shelf
148 pushes the outer sheath 122 so it rotates along with the inner
sheath 120. Therefore, when the bevel orientation collar 108 is
rotated, for example in the direction shown by arrow 168, both the
inner sheath 120 and the outer sheath 122 rotate together, for
example in the direction shown by arrow 170.
[0087] FIGS. 14 and 15 illustrate how rotation of the bevel
orientation collar 108 translates into rotation of internal
components of the syringe assembly 100 and, ultimately, rotation of
the needle 114. When rotation of the bevel orientation collar 108
causes the inner sheath 120 and outer sheath 122 to rotate as shown
in FIG. 14, the rotation is also transferred to the outer top 128
as shown in FIG. 15. The clips 134 of the outer top 128 extend
outward into the slot 156 in the outer sheath 122 and lock between
edges 158 of the slot 156. When the outer sheath 122 rotates, for
example in the direction shown by arrow 172, the edges 158 between
which clip 134 is locked force the outer top 128 to rotate as well,
for example, in the direction shown by arrow 174.
[0088] When the syringe assembly 100 is made, the outer top 128 is
dropped into the inner housing 126 to hold the outer top 128, inner
sheath 120, and outer sheath 122 within the syringe assembly 100
and create the inner chamber that receives the syringe. The inner
housing 126 does not rotate within the syringe assembly 100. To
allow for unrestrained rotation of the outer top 128, the inner
housing 126 has cutouts on either side to accommodate the geometry
of the rim of the outer top 128, and allow a portion of the rim of
the outer top 128 to extend beyond the sides of the inner housing
126. The accommodating cutouts thus allow the outer top 128 to
rotate within the inner housing 126, while the inner housing 126
remains static. In certain embodiments, the inner housing 126 has a
different geometry than the outer top 128 that could interfere with
rotation of the outer top 128. For example, in the embodiment shown
in FIG. 16, the inner housing 126 has a substantially oval shape,
while the outer top 128 has a substantially circular shape. Cutouts
in the inner housing 126 avoid interference from the sides of the
oval-shaped inner housing 126 on the rotation of the circular outer
top 128.
[0089] The outer top 128 has an opening 162 that receives a collar
of a syringe barrel inserted into the syringe assembly 100. The
shape of the opening is shaped to match the shape of the syringe
barrel collar. As shown in FIG. 15, the shape of this opening and
of the syringe barrel collar is preferably non-circular, thus
causing a syringe barrel inserted into the syringe assembly 100 to
rotate when the outer top 128 rotates as a result of the
interaction between the outer top 128 and the collar of the syringe
barrel. When the outer top 128 is rotated, the full barrel of the
syringe will also rotate, thus causing the needle that extends from
the lower end of the syringe assembly 100 to rotate.
[0090] During operation of the bevel orientation mechanisms shown
herein, rotation of the bevel orientation collar 108 is transferred
to rotation of the needle 114, allowing the user to orient and
position the needle bevel. To operate the bevel orientation
mechanism, a user first manually rotates the bevel orientation
collar 108. The notches 154 in the bevel orientation collar 108
hold the clips 152 of the inner sheath 120 and force the clips 152
and inner sheath 120 to rotate along with the bevel orientation
collar 108. When inner sheath 120 rotates, the shelf 148 of inner
sheath 120 exerts a force on the edges 158 of the slot 156 in the
outer sheath 122, which causes the outer sheath 122 to rotate along
with the inner sheath 120. The edges 158 of the slot 156 transfer
the rotation force of the outer sheath 122 to the outer top 128,
which is locked into the slot 156 by clips 134 on the outer top
128. The outer top 128 holds a collar of a syringe barrel in its
opening, and the rotation of the outer top 128 causes the barrel
124 of the syringe held within the syringe assembly 100, along with
the needle 114 extending from the housing 104 of the syringe
assembly 100, to rotate.
[0091] FIGS. 17-23 show an illustrative process for making a
syringe assembly. Notably, the process shown is a continuous
process that allows all components of the syringe assembly to be
manufactured at a single manufacturing site. This may be preferable
if, for example, special approval or certification is needed for a
manufacturing site to be able to place a syringe with medication
into the syringe assembly. If such certification is required, the
full manufacturing process can be carried out at a single
manufacturing site that has such clearance in order to streamline
the assembly process.
[0092] As shown in FIG. 17, the assembly process includes coupling
the inner sheath 200 and outer sheath 202. The inner sheath 200 is
passed into the top 244 of the outer sheath 202, and clips 204 of
the inner sheath 200 contact the outer sheath 202 and deflect
inward in the direction shown by arrows 246 due to the slot 206 cut
in the inner sheath 200, as the inner sheath 200 passes through the
outer sheath 202. These clips 204 then reflect to their original
configuration when they pass through the bottom of the outer sheath
202. The inner sheath 200 and outer sheath 202 are aligned such
that the shelf 208 of the inner sheath 200 extends laterally
outward from the slot 248 in the outer sheath 202 when the two
components are assembled together.
[0093] As shown in FIG. 18, the assembly process also includes
coupling the outer top 210 and inner housing 212. The outer top 210
is dropped into the top opening of the inner housing 212 and the
rim 216 of the outer top 210, which is wider than the bottom edge
250 of the inner housing 212, keeps the outer top 210 from passing
through the bottom opening of the inner housing 212. The cutouts
214 on the side of the inner housing 212 receive the rim 216 of the
outer top 210. Because the inner housing 212 and outer top 210 have
different geometries, the cutouts 218 allow the rim 216 to extend
beyond the sides of the inner housing 212. This allows the outer
top 210 to rotate independently of the inner housing 212, as the
sides of the inner housing 210 do not inhibit the rotation of the
outer top 210.
[0094] A retainer 218 is placed into the assembly of the inner
housing 212 and outer top 210, as shown in FIG. 19. Once the
retainer 218 is dropped into the assembly, openings 252 on the
lateral ends 226 of the retainer 218 align with corresponding
openings 254 in the inner housing 212 to create spaces that will
later receive the retaining clips 224 of a housing 220. The
retainer 218 shown in FIG. 19 is not configured to contact an
injection plunger in the finished syringe assembly, and thus
requires an actuator that triggers the shield mechanism to be
subsequently added to the assembly later. In certain embodiments, a
retainer that includes a collar or some other mechanism for
contacting a syringe plunger and does not require an intermediate
actuator may be added at this step instead of retainer 218.
[0095] As shown in FIG. 20, the sheath assembly 256, the inner
housing assembly 258, and a housing 220 are coupled with a spring
222 to create the spring-loaded needle shielding mechanism of the
syringe assembly. To assemble the components, the assembly 256 of
the inner sheath 200 and outer sheath 202 is placed into the
housing 220, and the lower end 260 of the inner sheath 200 extends
beyond the lower opening 262 of the housing 220. The spring 222 is
placed within the outer sheath 202 and rests on the upper end of
the inner sheath 200. The assembly of the retainer 218, inner
housing 212 and outer top 210 is then placed on the top end of the
spring 222 such that the spring 222 contacts a portion of the outer
top 210. The outer top 210 and inner housing 212 assembly 258 is
then pressed downward toward the sheath assembly, compressing the
spring 222 and spring-loading the shielding-firing mechanism. The
spring-loaded mechanism is locked in place after the retainer 218,
inner housing 212 and outer top 210 are pressed into the housing
220 and the retaining clips 224 on the housing 220 engage the
lateral ends 226 of the retainer 218.
[0096] As shown in FIG. 21, a bevel orientation collar 228 is
placed onto the lower end of the syringe assembly. Once the
components of the needle shielding mechanism are locked in place,
the bevel orientation collar 228 is placed over the outer and inner
sheath 200 and contacts the housing 220. The clips 204 of the inner
sheath 200 engage the notches 230 on the bevel orientation collar
228 to couple the two components, as discussed above with respect
to FIGS. 12 and 13. At this point in the assembly process, the
needle-shielding mechanism is spring-loaded, and the bevel
orientation collar 228 is rotated so as to rotate the inner sheath
200 and outer sheath 202, which in turn causes rotation of the
outer top 210. With the bevel orientation mechanism and shielding
mechanism assembled, the syringe assembly is ready to receive a
syringe.
[0097] A syringe 232 is placed into the assembly as shown in FIG.
22. The syringe may be pre-filled with a certain dosage of
medication, or may be an empty standard hypodermic syringe that can
be filled with medication by a user prior to injection. As shown,
the top collar 234 of the syringe 232 is a non-circular shape that
matches the shaped opening of the outer top 210. The non-circular
shape of the top collar 234 and the opening of the outer top 210
rotatably couples the two components.
[0098] The top cover 236 and an actuator 238 are placed onto the
assembly as shown in FIG. 23. The actuator 238 is configured to
interact with retainer 218 in the finished assembly. The actuator
238 is positioned and shaped such that a force will be exerted on
the actuator 238 by a plunger when an injection is given, and the
force will be transferred to the retainer 218 to trigger the needle
shielding mechanism. In certain embodiments, a retainer may be used
that interacts with a plunger directly, and only a top cover
without any actuator is placed on the assembly in this step. The
round pegs 240 on the underside of the top cover 236 are placed
into the receiving holes 242 in the inner housing 212 shown in FIG.
22. When the top cover 236 and actuator 238 are placed onto the
assembly, the ends 226 of the actuator 238 contact the retainer
218. This contact creates the mechanism that moves the retainer 218
laterally and triggers the needle shielding mechanism when a
plunger is depressed into the syringe assembly. Finally, to
complete the assembly, a plunger is placed into the syringe
assembly and a pull cap is placed over the needle.
[0099] It is to be understood that the foregoing description is
merely illustrative and is not to be limited to the details given
herein. While several embodiments have been provided in the present
disclosure, it should be understood that the disclosed systems,
devices, and methods, and their components, may be embodied in many
other specific forms without departing from the scope of the
disclosure.
[0100] Variations and modifications will occur to those of skill in
the art after reviewing this disclosure. The disclosed features may
be implemented, in any combination and subcombinations (including
multiple dependent combinations and subcombinations), with one or
more other features described herein. The various features
described or illustrated above, including any components thereof,
may be combined or integrated in other systems. Moreover, certain
features may be omitted or not implemented.
[0101] Examples of changes, substitutions, and alterations are
ascertainable by one skilled in the art and could be made without
departing from the scope of the information disclosed herein. All
references cited herein are incorporated by reference in their
entirety and made part of this application.
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