U.S. patent application number 12/821822 was filed with the patent office on 2010-10-14 for pre-filled syringe having internal guard.
Invention is credited to Don Millerd.
Application Number | 20100262122 12/821822 |
Document ID | / |
Family ID | 37772053 |
Filed Date | 2010-10-14 |
United States Patent
Application |
20100262122 |
Kind Code |
A1 |
Millerd; Don |
October 14, 2010 |
Pre-Filled Syringe Having Internal Guard
Abstract
A method involving a syringe, a plunger, a needle, and a guard
is described. The method may comprise the guard moving and/or
translating within the syringe. In some versions, the plunger may
be inserted into a syringe body of the syringe. The plunger may be
moved within the syringe body. In some versions, the guard may have
a retracted position, and the guard may travel axially within the
syringe body. In some versions, the guard may translate within the
syringe body such that it touches the skin of the patient. In some
versions, the guard may cover the needle by axial translation
within the syringe body.
Inventors: |
Millerd; Don; (San Diego,
CA) |
Correspondence
Address: |
FROST BROWN TODD, LLC
2200 PNC CENTER, 201 E. FIFTH STREET
CINCINNATI
OH
45202
US
|
Family ID: |
37772053 |
Appl. No.: |
12/821822 |
Filed: |
June 23, 2010 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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12256139 |
Oct 22, 2008 |
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12821822 |
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11211336 |
Aug 25, 2005 |
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12256139 |
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Current U.S.
Class: |
604/506 ;
29/428 |
Current CPC
Class: |
A61M 5/283 20130101;
A61M 5/2429 20130101; A61M 2005/3261 20130101; A61M 2005/3247
20130101; A61M 5/326 20130101; Y10T 29/49826 20150115 |
Class at
Publication: |
604/506 ;
29/428 |
International
Class: |
A61M 5/32 20060101
A61M005/32; B23P 11/00 20060101 B23P011/00 |
Claims
1. A method comprising the steps of: providing a syringe having a
plunger, a needle in communication with the syringe, and a
cylindrical guard, the syringe having a syringe body comprising a
proximal portion, a distal portion, and a body lumen, the guard
being in communication with the syringe body and being configured
to extend distally from the syringe body; inserting the needle into
a patient; retaining the guard in a retracted position; actuating
the plunger of the syringe; releasing the guard in response to
actuation of the plunger such that the guard is released to travel
axially within the syringe body; biasing the guard in a distal
direction; removing the needle from the patient; and locking the
guard in an extended position, wherein the guard covers a distal
end of the needle in the extended position to prevent accidental
needlesticks.
2. The method of claim 1, wherein the step of locking the guard in
the extended position comprises preventing the guard from being
retracted proximally.
3. The method of claim 1, wherein the step of biasing the guard in
the distal direction comprises providing a spring to bias the guard
distally.
4. The method of claim 1, wherein the step of releasing the guard
in response to action of the plunger comprises releasing a flexible
hinge positioned within the syringe body.
5. The method of claim 4, wherein the flexible hinge is released by
the distal actuation of the plunger.
6. The method of claim 1, wherein the step of releasing the guard
comprises passively releasing the guard.
7. The method of claim 1, wherein the plunger is a pre-filled
medicament cartridge that is distally advanced to release the
guard.
8. A method comprising the steps of: providing a distally biased
guard configured to cover a tip of a needle, the guard being
positioned within a syringe body having a proximal portion and a
distal portion, the syringe being in communication with the needle;
inserting a plunger into the proximal portion of the syringe body;
piercing the skin of a patient with the needle; advancing the
plunger within the syringe body; releasing the guard; translating
the guard distally within the syringe body such that the guard
contacts the skin of the patient; and removing the needle from the
patient; and locking the guard in a distal position, wherein the
guard covers the tip of the needle in the distal position.
9. The method of claim 8, wherein the step of releasing the guard
comprises actuating a flexible hinge configured to release the
guard.
10. The method of claim 8, wherein the plunger is a pre-filled
cartridge.
11. The method of claim 8, further comprising locking the guard in
the extended position such that the guard may not be retracted
proximally.
12. The method of claim 8, wherein the step of translating the
guard comprises the guard translating proximally and distally
within the syringe body in response to the position of the syringe
body relative to the patient's skin.
13. The method of claim 12, wherein the step of translating the
guard comprises the guard translating proximally and distally
within the syringe body until the guard is locked into the distal
position.
14. The method of claim 8, wherein the guard is locked into the
distal position immediately upon removal of the needle from the
patient.
15. The method of claim 14, wherein the syringe body and plunger
are configured for single use.
16. A method comprising the steps of: providing a guard to cover a
tip of a needle, the guard being positioned internally within a
syringe body, the guard being in communication with a biasing
member operable to bias the guard in a distal direction, the guard
further comprising a retracted position, a released position, and a
locked position, the needle being axially mounted to the syringe
body; inserting a plunger into the syringe body, wherein the
plunger is in communication with a pre-filled cartridge; piercing
the pre-filled cartridge with a proximal portion of the needle,
thereby establishing fluid communication between the needle and the
pre-filled cartridge; urging the plunger in the distal direction;
releasing the guard from the retracted position, wherein the tip of
the needle is exposed, to the released position wherein the guard
is configured to axially translate within the syringe body; and
extending the guard from the released position to the locked
position, wherein the guard is fixed in the locked position such
that it may not be axially translated.
17. The method of claim 16, wherein the plunger is a pre-filled
cartridge.
18. The method of claim 16, wherein the step of releasing the guard
from the retracted position comprises releasing a flexible
hinge.
19. The method of claim 16, wherein the step of releasing the guard
from the retracted position comprises releasing the guard by distal
actuation of the plunger.
20. The method of claim 16, wherein the steps of releasing the
guard from the retracted position and extending the guard from the
released position to the locked position are configured to occur
with the passive operation of the syringe body and the plunger.
Description
PRIORITY
[0001] This application claims priority to U.S. Nonprovisional
patent application Ser. No. 12/256,139, filed Oct. 22, 2008,
entitled "Syringe Guard for Pre-Filled Medicament Vial" and U.S.
Nonprovisional patent application Ser. No. 11/211,336, filed Aug.
25, 2005, entitled "Syringe Guard for Pre-Filled Medicament Vial,"
the disclosures of which are herein incorporated by reference in
their entirety.
FIELD OF THE INVENTION
[0002] The present invention pertains generally to fluid infusion
devices. More particularly, the present invention pertains to fluid
infusion devices that include an automatically activated guard for
covering and protecting the needle of the device after its use. The
present invention is particularly, but not exclusively, useful as a
syringe, with a needle guard, where the syringe is engageable with
a pre-filled fluid vial to establish a fluid infusion device.
BACKGROUND OF THE INVENTION
[0003] Fluid medicaments, as well as other commercially available
fluids, can be purchased in a variety of different type containers.
The container of particular interest here, however, is the
pre-filled vial. Typically, such a container/vial is made of glass,
and is formed as a hollow cylindrical tube that has two open ends.
One end can then be closed with a plug, and a stopper can be
inserted through the opposite end to create a fluid chamber in the
vial between the plug and the stopper. Thus, the chamber of the
container/vial can then be filled with a predetermined amount of a
desired fluid (e.g. a fluid medicament).
[0004] For the context wherein a container, such as the pre-filled
fluid vial described above, is to be used for an infusion of fluid,
the fluid must somehow be brought into fluid communication with a
needle. Heretofore, a typical procedure for accomplishing this
purpose has been to penetrate the stopper of the container/vial
with a hypodermic needle. Fluid in the vial is then evacuated from
the fluid chamber of the vial. In this example, the fluid is caused
to flow through the needle and into the fluid chamber of a syringe.
The now-filled syringe can then be disengaged from the vial and
used for an infusion. The procedure just described, however, is
somewhat cumbersome. In particular, this is so because the filling
of the syringe, and the infusion of the fluid are performed as two
separate and distinct operations. And, as such, each has its own
attendant hazards. Further, with the increased awareness of
communicable diseases (e.g. AIDS), the protection of the user from
unwanted needle sticks has become of paramount importance. The
consequence here is that the commercial potential for using
pre-filled fluid vials may be enhanced by reducing the number of
required manipulations in a procedure, and by directly
incorporating pre-filled fluid vials into systems/devices that
automatically protect the user from unwanted or inadvertent needle
sticks.
[0005] In light of the above, it is an object of the present
invention to provide a device which can be engaged with a
pre-filled fluid vial for infusing fluid directly from the vial.
Another object of the present invention is to provide a device for
infusing a fluid medicament that automatically protects the user
from unwanted or inadvertent needle sticks after the fluid from a
pre-filled fluid vial has been infused. Yet another object of the
present invention is to provide a device for infusing fluid from a
pre-filled vial that is easy to use, is relatively simple to
manufacture, and is comparatively cost effective.
SUMMARY OF THE INVENTION
[0006] In accordance with the present invention, a device is
provided for expelling fluid from a pre-filled vial, through a
needle. As envisioned for the present invention, the pre-filled
fluid vial will have a hollow, cylindrical-shaped, glass wall, with
a plug covering one of its open ends. A stopper will be inserted
into the other open end of the cylindrical wall to thereby create a
fluid chamber in the vial for holding fluid therein between the
plug and the stopper.
[0007] Structurally, the device of the present invention includes a
hollow, cylindrical-shaped syringe body that is formed with a lumen
and has an open proximal end, and an open distal end. Thus, the
syringe body defines a longitudinal axis that extends between the
two ends. Further, an elongated adapter is axially aligned within
the syringe body, and it is fixedly mounted in the lumen of the
syringe body. As so mounted, a space is created between the adapter
and the syringe body.
[0008] For the device of the present invention, the adapter is
substantially cylindrical in shape, and it is formed with a lumen.
Additionally, a hollow needle is mounted in the lumen of the
adapter such that the needle extends along the longitudinal axis of
the syringe body. Importantly, the adapter is formed with both a
proximal hinge, and a distal hinge. Both of these hinges are
so-called "living" hinges, and they are longitudinally aligned with
each other. The adapter is also formed with at least one slot that
extends along its length.
[0009] In addition to the needle, a guard is also mounted in the
lumen of the adapter. Specifically, the guard is cylindrical shaped
and it is positioned within the lumen of the adapter for axial
movement over the needle between a first position and a second
position. In its first position, the guard is held within the
syringe body to expose a distal portion of the needle as it extends
beyond the distal end of the syringe body. Structurally, the guard
is held in the first position by a flexible hinge lock on the guard
that engages with the adapter. Upon release of the hinge lock,
however, the guard moves distally into its second position. In its
second position, the guard extends beyond the distal end of the
syringe body, to cover the distal portion of the needle. For the
device of the present invention, this distal movement of the guard
in the axial direction is caused by a spring that is located
between the adapter and the guard to push distally against the
guard. This movement, however, is limited by a tab on the guard
that extends into the slot of the adapter.
[0010] In operation, the fluid vial is first engaged with the
proximal end of the syringe body. With this engagement, the
proximal end of the needle pierces the stopper in the vial. This
then establishes fluid communication between the fluid chamber of
the vial and the needle. Also, during this engagement, the wall of
the vial is introduced into the space between the syringe body and
the adapter. Subsequently, as the wall of the vial is advanced
distally into the space between the syringe body and the adapter,
it activates the proximal hinge of the adapter. When activated, the
proximal hinge of the adapter releases the hinge lock of the guard
for movement of the guard in the distal direction. As indicated
above, this causes the guard to extend beyond the distal end of the
syringe body to cover and protect the distal end of the needle. It
is to be noted here, however, that if the needle is being used for
an infusion, the body into which the infusion is being made may
prevent the guard from making its full distal movement. Next, as
further distal movement of the wall of the vial is made during the
infusion, the wall repositions the distal hinge of the adapter to
prevent a subsequent proximal movement of the guard. Thus,
subsequent to an infusion, and after the needle has been withdrawn
from the body being infused, the guard remains extended beyond the
distal end of the syringe body. This causes the guard to cover the
needle and to thereby protect against accidental of inadvertent
sticks by the needle.
BRIEF DESCRIPTION OF THE DRAWINGS
[0011] The novel features of this invention, as well as the
invention itself, both as to its structure and its operation, will
be best understood from the accompanying drawings, taken in
conjunction with the accompanying description, in which similar
reference characters refer to similar parts, and in which:
[0012] FIG. 1 is a view of an assembled device for infusing fluids
from a pre-filled vial, in accordance with the present
invention;
[0013] FIG. 2 is an exploded perspective view of the component
elements of the device;
[0014] FIG. 3 is a cross section view of a pre-filled vial for use
with the device of the present invention as seen along the line 3-3
in FIG. 1;
[0015] FIG. 4 is an elevation view of the device of the present
invention ready for use with a pre-filled vial, and with portions
broken away for clarity;
[0016] FIG. 5A is an elevation view of a device in accordance with
the present invention when it is engaged with a pre-filled vial and
ready for use in an infusion procedure, again, with portions of the
device broken away for clarity;
[0017] FIG. 5B is a view of the device shown in FIG. 5A during an
infusion procedure, when configured with the vial engaging the
adapter of the device to release the guard of the device for its
distal movement; and
[0018] FIG. 5C is a view of the device shown in FIGS. 5A and 5B,
after an infusion procedure.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0019] Referring initially to FIG. 1, a device for expelling fluid
from a pre-filled vial is shown and is generally designated 10. As
shown, the device 10 includes a syringe body 12 that is engaged
with a pre-filled vial/container 14. In accordance with the
discussion below, it will be appreciated that the device 10 is
useful for expelling fluid from the vial 14, and through a hollow
needle 16, during an infusion procedure. Further, it will also be
appreciated that the device 10 provides structure for covering the
needle 16 after the infusion procedure has been completed. The
purpose here is to prevent accidental or inadvertent sticks with
the needle 16 that might otherwise occur after using the device 10.
Preferably, the needle 16 is made of a stainless steel type
material.
[0020] The various structural components of the device 10 will,
perhaps, be best appreciated with reference to FIG. 2. There it can
be seen that the pre-filled vial 14 includes a hollow cylindrical
wall 18 that has both an open proximal end 20 and an open distal
end 22. Further, the vial 14 includes a plug 24 and a stopper 26.
When the vial 14 is assembled, as shown in FIG. 3, the plug 24 is
positioned to cover the proximal end 20, and the stopper 26 is
inserted through the distal end 22. Thus, a fluid chamber 28 is
created for the vial 14. A fluid (e.g. a fluid medicament) can then
be held inside the fluid chamber 28 that is surrounded by the wall
18 and enclosed by the plug 24 and the stopper 26. As intended for
the device 10, the stopper 26 is moveable within the vial 14, and
the wall 18 is preferably made of a rigid transparent material,
such as glass.
[0021] Still referring to FIG. 2, it will be seen that the device
10 includes an adapter 30. As shown, the adapter 30 is elongated
and is substantially cylindrical in shape. It is also shown in FIG.
2 that the adapter 30 is formed with a proximal hinge 32 and a
distal hinge 34. For purposes of the present invention, both of the
hinges 32 and 34 are so-called "living" hinges, in that they are
integral with the adapter 30. It is also seen in FIG. 2 that the
adapter 30 is formed with a slot 36 that extends longitudinally
along the adapter 30. Actually, the adapter 30 can have two such
slots that are diametrically opposite each other (one such slot,
however, is not shown in FIG. 2). Further, the adapter 30 is formed
with a series of circumferentially oriented structural detents 38.
Also, in conjunction with the proximal hinge 32, the adapter 30 is
formed with a slit 40 into which the hinge 32 can be deflected. As
shown, the slit 40 creates an abutment 42 at its distal end.
[0022] To best appreciate how the needle 16 and the adapter 30 are
mounted on the syringe body 12, it is necessary to cross reference
FIG. 2 with FIG. 4. With this cross-reference, it can be seen that
the needle 16 is fixedly held at the proximal end 44 of the adapter
30 (see FIG. 4). Also, it can be seen that the detents 38 at the
distal end 46 of the adapter 30 are fixedly engaged with the
syringe body 12 (see FIG. 2). A consequence of this arrangement is
that a space 48 is created between the adapter 30 and the syringe
body 12.
[0023] FIG. 2 also shows that the device 10 includes a guard 50.
Specifically, the guard 50 is a hollow, substantially
cylindrical-shaped structure that defines a lumen 52, and that has
diametrically opposed tabs 54 (one such tab 54 is not shown).
Additionally, and importantly, the guard 50 is formed with a hinge
lock 56. In its cooperation with the adapter 30, the guard 50 is
inserted into the lumen 58 of the adapter 30, over the needle 16.
More specifically, the guard 50 inserted into the lumen 58 until
the hinge lock 56 of guard 50 extends through the slit 40 of
adapter 30, for engagement of the hinge lock 56 with the abutment
42. In this combination, a spring 60 (see FIG. 4) is positioned
between the guard 50 and the proximal end 44 of the adapter 30 to
urge the guard 50 in a distal direction. This, of course, also
urges the hinge lock 56 against the abutment 42 to hold the guard
50 in the position shown in FIG. 4.
[0024] With the guard 50 engaged to the adapter 30 as described
above, and with the adapter 30 mounted on the syringe body 12 as
also described above, the needle 16 will be longitudinally aligned
along the axis 61 that is defined by the syringe body 12 (see FIG.
2). A proximal shield 62 can then be engaged with the syringe body
12 to cover and protect the proximal end 64 of the needle 16.
Similarly, a distal shield 66 can be engaged with the syringe body
12 to cover and protect the distal end 68 of the needle 16. The
result is a combination of components as shown in FIG. 4.
[0025] In the operation of the device 10 of the present invention,
the proximal shield 62 is removed from the syringe body 12 to
expose the proximal end 64 of the needle 16. The pre-filled vial 14
is then engaged with the syringe body 12. Specifically, with this
engagement, the proximal end 64 of the needle 16 penetrates through
the stopper 26 to establish fluid communication between the needle
16 and fluid in the chamber 28 of vial 14. Also, with this
engagement, the end 22 of wall 18 of the vial 14 is positioned in
the space 48 between the syringe body 12 and the adapter 30. The
distal shield 66 can then be removed from the syringe body 12 to
expose a distal portion of the needle 16, as shown in FIG. 5A. The
device 10 is now ready for an infusion procedure.
[0026] To perform an infusion procedure, with the device 10 in the
configuration shown in FIG. 5A, the distal end 68 of the needle 16
is penetrated into the body that is to be infused (not shown). The
pre-filled fluid vial 14 is then advanced distally along the axis
61, and into the syringe body 12. With this advancement, the end 22
of wall 18 comes into contact with the proximal hinge 32 of adapter
30 (see FIG. 5B). This contact then causes the proximal hinge 32 to
deflect into the slit 40 of the adapter 30, and against the hinge
lock 56 of the guard 50. In turn, this deflection moves the hinge
lock 56 from its position against the abutment 42 of adapter 30.
This frees the guard 50 for distal movement along the axis 61 under
the influence of spring 60. As stated above, a full distal movement
of the guard 50 may not occur at this time due to contact between
the guard 50 and the body (not shown) into which the needle 16 may
be penetrated.
[0027] As the pre-filled vial 14 is further advanced from its
position in FIG. 5B to the position shown in FIG. 5C, the end 22 of
wall 18 comes into contact with the distal hinge 34 of the adapter
30. This contact then causes the distal hinge 34 to be deflected
and held in a position wherein it, the hinge 34, will block any
return movement of the guard 50 in a proximal direction.
Consequently, when the device 10 is configured as shown in FIG. 5C,
and the guard 50 is no longer constrained to move distally, the
hinge 34 and syringe body 12 cooperate to block a proximal movement
of the guard 50. This causes the guard 50 to remain in place over
the distal end 68 of the needle 16, to thereby prevent accidental
or inadvertent "sticks".
[0028] While the particular Syringe Guard for Pre-Filled Medicament
Vial as herein shown and disclosed in detail is fully capable of
obtaining the objects and providing the advantages herein before
stated, it is to be understood that it is merely illustrative of
the presently preferred embodiments of the invention and that no
limitations are intended to the details of construction or design
herein shown other than as described in the appended claims.
* * * * *