U.S. patent application number 10/164944 was filed with the patent office on 2006-01-19 for safety shield for medical needles.
Invention is credited to F. Mark Ferguson, Kendall P. Thorne.
Application Number | 20060015073 10/164944 |
Document ID | / |
Family ID | 29732048 |
Filed Date | 2006-01-19 |
United States Patent
Application |
20060015073 |
Kind Code |
A9 |
Ferguson; F. Mark ; et
al. |
January 19, 2006 |
SAFETY SHIELD FOR MEDICAL NEEDLES
Abstract
A medical needle shield apparatus is provided which includes an
extensible shield having a first segment and a second segment
extending therefrom. The second segment includes an opening
configured for clearance of a medical needle of a medical needle
device during attachment of the extensible shield to the medical
needle device. The second segment defines a planar surface adjacent
a distal portion thereof. The planar surface is configured to
engage the needle for disposing the shield in an extended position.
In alternate embodiment, the medical needle shield apparatus has a
syringe having a needle hub supporting a needle. The first segment
articulates from a collar disposed about the needle hub. The collar
includes a pair of latches. The opening is configured for travel
about the needle to facilitate extension of the shield from a
retracted position to an extended position. The second segment
further includes a proximal fulcrum that engages the needle to
facilitate extension of the shield. The second segment also has a
pair of catches. The catches are engageable with the latches to
maintain the shield in the retracted position. The second segment
has a nose portion defining a planar surface configured to engage
the needle to facilitate fixing the shield in the extended
position.
Inventors: |
Ferguson; F. Mark; (Salt
Lake City, UT) ; Thorne; Kendall P.; (Layton,
UT) |
Correspondence
Address: |
MARK S. LEONARDO, ESQ.;BROWN RUDNICK BERLACK ISRAELS LLP
ONE FINANCIAL CENTER
BOSTON
MA
02111
US
|
Prior
Publication: |
|
Document Identifier |
Publication Date |
|
US 20030004465 A1 |
January 2, 2003 |
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Family ID: |
29732048 |
Appl. No.: |
10/164944 |
Filed: |
June 6, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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09892593 |
Jun 27, 2001 |
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10164944 |
Jun 6, 2002 |
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09433449 |
Nov 4, 1999 |
6280420 |
|
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09892593 |
Jun 27, 2001 |
|
|
|
09434036 |
Nov 4, 1999 |
6254575 |
|
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09892593 |
Jun 27, 2001 |
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09619190 |
Jul 19, 2000 |
6592556 |
|
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09892593 |
Jun 27, 2001 |
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60254506 |
Dec 8, 2000 |
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|
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60275810 |
Mar 14, 2001 |
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60275886 |
Mar 14, 2001 |
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60296968 |
Jun 8, 2001 |
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Current U.S.
Class: |
604/198 |
Current CPC
Class: |
A61B 5/150244 20130101;
A61B 5/150809 20130101; A61B 5/150389 20130101; A61B 5/150816
20130101; A61B 5/150236 20130101; A61B 5/153 20130101; A61M 25/0625
20130101; A61B 5/15003 20130101; A61M 5/3202 20130101; A61B
5/150824 20130101; A61B 5/150503 20130101; A61M 5/3216 20130101;
A61J 1/2096 20130101; A61B 5/150717 20130101; A61J 1/2055 20150501;
A61M 5/3275 20130101; A61M 2005/3247 20130101; Y10S 128/919
20130101; A61M 5/158 20130101; A61M 2005/1581 20130101; A61J 1/201
20150501; A61B 5/150671 20130101 |
Class at
Publication: |
604/198 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A medical needle shield apparatus comprising: an extensible
shield including a first segment and a second segment extending
therefrom, the second segment including an opening configured for
clearance of a medical needle of a medical needle device during
attachment of the shield to the medical needle device; and the
second segment defining a planar surface adjacent a distal portion
thereof, the planar surface being configured to engage the needle
for disposing the shield in an extended position.
2. A medical needle shield apparatus as recited in claim 1, wherein
the apparatus is monolithically formed.
3. A medical needle shield apparatus as recited in claim 1, wherein
the first segment is articulated to a collar mounted to a device
supporting the needle.
4. A medical needle shield apparatus as recited in claim 1, wherein
the first segment has a pair of arms articulated to a collar
mounted to a device supporting the needle.
5. A medical needle shield apparatus as recited in claim 3, wherein
the collar is configured for mounting to a syringe.
6. A medical needle shield apparatus as recited in claim 3, wherein
the collar includes a latch that engages the extensible shield to
releasably lock the extensible shield in a retracted position.
7. A medical needle shield apparatus as recited in claim 6, wherein
the latch engages a catch on the second segment to releasably lock
the extensible shield in a retracted position.
8. A medical needle shield apparatus as recited in claim 3, wherein
the collar includes a pair of latches disposed for engagement with
a pair of catches of the second segment to releasably lock the
extensible shield in a retracted position.
9. A medical needle shield apparatus as recited in claim 1, wherein
the opening is configured for travel about the needle during
extension of the shield.
10. A medical needle shield apparatus as recited in claim 1,
wherein the second segment includes a fulcrum disposed adjacent a
proximal portion thereof, the fulcrum configured to engage the
needle to facilitate extension of the shield from a retracted
position to the extended position.
11. A medical needle shield apparatus as recited in claim 10,
wherein the fulcrum includes a slot configured to guide the needle
therein during extension of the shield from the retracted position
to the extended position.
12. A medical needle shield apparatus as recited in claim 1,
wherein the second segment includes a nose portion which includes
at least a portion of the planar surface.
13. A medical needle shield apparatus as recited in claim 12,
wherein the nose portion defines a cavity for disposal of the
needle therein.
14. A medical needle shield apparatus as recited in claim 13,
wherein the cavity is defined by side walls and the planar surface
of the nose portion.
15. A medical needle shield apparatus as recited in claim 1,
wherein the second segment includes a lock that engages the needle
to fix the shield in the extended position.
16. A medical needle shield apparatus as recited in claim 1,
wherein the first segment includes a lock and the second segment
includes a lock which cooperate to fix the shield in the extended
position.
17. A medical needle shield apparatus as recited in claim 1,
wherein the first segment includes a manual actuator configured to
provide an engagement surface for manipulating the shield to the
extended position.
18. A medical needle shield apparatus comprising: an extensible
shield including a first segment and a second segment extending
therefrom, the second segment having extending means for
facilitating extension of the shield between a retracted position
to an extended position about a needle.
19. A medical needle shield apparatus as recited in claim 18,
wherein the second segment has a barbed flap lock that engages the
needle and fixes the shield in the extended position.
20. A medical needle shield apparatus comprising: a syringe having
a needle hub supporting a needle; and an extensible shield
including a first segment and a second segment articulating
therefrom, the first segment articulating from a collar disposed
about the needle hub, the collar including a pair of latches; and
the second segment defining an opening configured for travel about
the needle to facilitate extension of the shield between a
retracted position to an extended position the second segment
further including a proximal fulcrum having a slot that engageably
receives the needle to facilitate extension of the shield and a
pair of catches; the catches being engageable with the latches to
maintain the shield in the retracted position, the second segment
having a nose portion defining a planar surface configured to
engage the needle to facilitate disposing the shield in the
extended position; the second segment further including a barbed
flap lock that engages the needle and fixes the shield in the
extended position.
21. A method of assembling a medical needle shield with a medical
needle device, the method comprising the steps of: providing a
medical needle device having a medical needle extending therefrom;
providing a medical needle shield including: an extensible shield
including a first segment and a second segment extending therefrom,
the second segment including an opening configured for clearance of
the medical needle during attachment of the medical needle shield
to the medical needle device, the opening being transversely
oriented relative to the distal segment; positioning the medical
needle shield for assembly with the medical needle device such that
the needle travels through the opening and the first segment is
disposed for mounting with the medical needle device; and mounting
the first segment to the medical needle device.
22. A method of assembling as recited in claim 21, the step of
providing a medical needle shield further including the proximal
segment being articulated to a collar and the step of mounting
further includes mounting the first segment to the medical needle
device by attaching the collar to an outer surface of the medical
needle device.
23. A method of assembling as recited in claim 21, wherein the step
of providing a medical needle shield includes a circumferential
wall of the second segment which defines the opening.
24. A method of assembling as recited in claim 21, wherein the step
of providing a medical needle device further includes a needle
cover mounted to the medical needle device and substantially
enclosing the medical needle and the step of positioning further
includes the needle cover traveling through the opening.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This patent application is a continuation-in-part of U.S.
Utility patent application Ser. No. 09/892,593, filed in the U.S.
Patent and Trademark Office on Jun. 27, 2001 by Ferguson et al.,
the entire contents of which being hereby incorporated by reference
herein.
BACKGROUND
[0002] 1. Technical Field
[0003] The present disclosure generally relates to safety shields
for medical needles, and more particularly, to safety shields that
are extensible to prevent hazardous exposure to a needle.
[0004] 2. Description of the Related Art
[0005] Problems associated with inadvertent needle sticks are well
known in the art of blood sampling, percutaneous medication
injection and other medical procedures involving use of medical
needles. Significant attention has been focused on needle stick
problems due to the contemporary sensitivity of exposure to AIDS,
Hepatitis and other serious blood-borne pathogen exposures.
[0006] Procedures for removing a needle from a patient commonly
require a clinician to use one hand to place pressure at the wound
site where a needle is being withdrawn, while removing the needle
device with the other hand. It is also common practice for a
clinician to give higher priority to care for the wound than is
given to disposal of the needle. In the case of typical needle
devices without safety shields, such priority either requires the
convenience of an available sharps container within reach or
another means for safe disposal, without leaving the patient's
side. Thus, the difficulty in providing adequate care while
following safety procedures is often compounded by the patient's
physical condition and mental state, such as in burn units and
psychiatric wards. Under such conditions, proper disposal of a used
needle, while caring for a patient, is a technological challenge to
the state of the art.
[0007] The widespread knowledge and history associated with needle
care and disposal problems have resulted in numerous devices for
preventing accidental needle sticks. Some devices utilize a
separate sheath or cap mounted over the needle after use. These
devices, however, require two handed manipulation from a
practitioner.
[0008] Other known devices employ sheaths that are spring
activated, telescoping, pivoting, etc. These devices, however, may
disadvantageously misfire or be cumbersome to activate. Further
drawbacks of current devices include high manufacturing cost due to
complexity and the number of parts. Thus, these type prior art
devices may not adequately and reliably shield needle infusion
and/or fluid collection apparatus to prevent hazardous
exposure.
[0009] Consequently, there remains a need to provide a more
satisfactory solution for needle safety devices by overcoming the
disadvantages and drawbacks of the prior art. Therefore, it would
be desirable to provide a more adequate and reliable medical needle
shield apparatus which employs an extensible safety shield to
prevent hazardous exposure to a needle. Such a needle shield
apparatus should be easily and reliably extendable to shield a
needle tip of a needle cannula. It would be desirable if the needle
shield apparatus was actuated via one handed operation. It would be
highly desirable if the medical needle shield apparatus facilitates
efficient assembly and manufacture thereof.
SUMMARY
[0010] Accordingly, the present disclosure addresses a need for a
medical needle shield apparatus which effectively and inexpensively
protects a medical needle of a syringe and/or fluid collection
device after use. The present disclosure resolves related
disadvantages and drawbacks experienced in the art. More
specifically, the apparatus and method of this invention constitute
an important advance in the art of safety needle devices.
[0011] In one particular embodiment, a prefilled medical needle
shield apparatus is provided in accordance with the principles of
the present disclosure. The prefilled medical needle shield
apparatus includes a collar and hingedly connected segments
extensible from the collar. The shield is extensible from a
retracted position to an extended position. The collar is
configured to attach to a distal end of a prefilled syringe.
[0012] The shield may be locked in the extended position. The
shield may also be irreversibly locked in the extended position.
The shield may be locked in the extended position via engagement
with the needle. The lock may include a portion configured to
flexibly engage the needle and bias to lockably retain the needle.
Alternatively, the shield includes locking means to lock the shield
in the extended position. In another embodiment, the distal end of
the shield includes a surface configured to enclose at least a
portion of the distal end of the needle. The distal end of the
shield may have a surface configured to align the shield with the
needle.
[0013] In another embodiment, the shield includes a catch that
engages a corresponding latch to releasably dispose the shield in
the retracted position. In another alternate embodiment, the shield
has a manipulating actuator configured to urge the shield towards
the extended position. The shield segments may be connected via
living hinges. The shield may include a needle flap lock that
engages the needle in the extended position.
[0014] In another embodiment, the distal segment has an underside
including a surface extending over at least a portion of the distal
segment for retaining the distal end of the needle. The shield may
include at least one flap lock associated with the distal segment
and/or proximal segment for securing the shield in the extended
position. The medical needle shield apparatus may include a
retainer for holding the segments in a retracted position. The
retainer can include a retainer arm disposed on the needle hub and
extending to a corresponding catch disposed on the shield in the
retracted position.
[0015] In another embodiment, at least one segment includes at
least one needle guide for facilitating extension of the segments
when extending the shield over the needle. The shield may further
include a raised surface for aid in urging the shield to the
extended position.
[0016] In another particular embodiment, in accordance with the
principles of the present disclosure, the medical needle shield
apparatus includes an extensible shield having a first segment and
a second segment extending therefrom. The second segment includes
an opening configured for clearance of a medical needle of a
medical needle device during attachment of the extensible shield to
the medical needle device. The second segment defines a planar
surface adjacent a distal portion thereof. The planar surface is
configured to engage the needle for disposing the shield in an
extended position. In another alternate embodiment, the second
segment has extending means for facilitating extension of the
shield from a retracted position to an extended position about a
needle.
[0017] In yet another alternate embodiment, the medical needle
shield apparatus has a syringe having a needle hub supporting a
needle. An extensible shield includes a first segment and a second
segment articulating therefrom. The first segment articulates from
a collar disposed about the needle hub. The collar includes a pair
of latches. The opening is configured for travel about the needle
to facilitate extension of the shield from a retracted position to
an extended position. The second segment further includes a
proximal fulcrum that engages the needle to facilitate extension of
the shield. The second segment also has a pair of catches. The
catches are engageable with the latches to maintain the shield in
the retracted position. The second segment has a nose portion
defining a planar surface configured to engage the needle to
facilitate fixing the shield in the extended position.
[0018] A method of assembling a medical needle shield with a
medical needle device is disclosed, in accordance with the
principles of the present disclosure. The method includes the steps
of: providing a medical needle device having a medical needle
extending therefrom; providing a medical needle shield including:
an extensible shield including a first segment and a second segment
extending therefrom, the second segment including an opening
configured for clearance of the medical needle during attachment of
the medical needle shield to the medical needle device, the opening
being transversely oriented relative to the distal segment;
positioning the medical needle shield for assembly with the medical
needle device such that the needle travels through the opening and
the first segment is disposed for mounting with the medical needle
device; and mounting the first segment to the medical needle
device.
[0019] The step of providing a medical needle shield may further
include the proximal segment being articulated to a collar and the
step of mounting further including mounting the first segment to
the medical needle device by attaching the collar to an outer
surface of the medical needle device.
[0020] The step of providing a medical needle shield may include a
circumferential wall of the second segment which defines the
opening. Alternatively, the step of providing a medical needle
device further includes a needle cover mounted to the medical
needle device and substantially enclosing the medical needle and
the step of manipulation further includes manipulation such that
the needle cover travels through the opening.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] The foregoing and other features and advantages of the
present disclosure will be more fully understood from the following
detailed description of the exemplary embodiments, taken in
conjunction with the accompanying drawings in which:
[0022] FIG. 1 is a perspective view of a medical needle safety
shield apparatus in accordance with the principles of the present
disclosure;
[0023] FIG. 2 is a cross-sectional view of the safety shield
apparatus shown in FIG. 1;
[0024] FIG. 3 is a perspective view of the safety shield apparatus
shown in FIG. 1 during extension;
[0025] FIG. 4 is a cross-sectional view of the safety shield
apparatus shown in FIG. 3;
[0026] FIG. 5 is a perspective view of the safety shield apparatus
shown in FIG. 1 in the extended position;
[0027] FIG. 6 is a cross-sectional view of the safety shield
apparatus shown in FIG. 4;
[0028] FIG. 7 is a top view of the safety shield apparatus shown in
FIG. 5;
[0029] FIG. 8 is a bottom view of the safety shield apparatus shown
in FIG. 5;
[0030] FIG. 8A is a cutaway perspective view of the safety shield
apparatus shown in FIG. 1;
[0031] FIG. 9 is a perspective view of the safety shield apparatus
shown in FIG. 1 separate from a prefilled syringe with a needle
cover;
[0032] FIG. 10 is a perspective view of the safety shield apparatus
attached to the prefilled syringe and the needle cover shown in
FIG. 9; and
[0033] FIG. 11 is a cutaway perspective view of an alternate
embodiment of a locking arrangement for the safety shield apparatus
shown in FIG. 1.
DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
[0034] The exemplary embodiments of the medical needle shield
apparatus and methods of operation disclosed are discussed in terms
of medical needles for infusion of intravenous fluids, medication
infusion or fluid collection, and more particularly, in terms of
needle shield apparatus employed with a needle cannula that prevent
hazardous exposure to the needle cannula, including, for example,
inadvertent needle stick. It is contemplated that the needle
cannula may be shielded during use including storage, transport,
fluid infusion and/or collection, subsequent thereto, etc. It is
envisioned that the present disclosure, however, finds application
to a wide variety of cannula needles and devices for the infusion
of preventive medications, medicaments, therapeutics, etc. to a
subject. It is also envisioned that the present disclosure may be
employed for collection of body fluids including those employed
during procedures relating to phlebotomy, digestive, intestinal,
urinary, veterinary, etc. It is contemplated that the medical
needle shield apparatus may be utilized with other medical needle
applications including phlebotomy devices, catheters, catheter
introducers, guide wire introducers, spinal and epidural, biopsy,
aphaeresis, dialysis, blood donor, Veress needles, Huber needles,
etc.
[0035] In the discussion that follows, the term "proximal" refers
to a portion of a structure that is closer to a clinician, and the
term "distal" refers to a portion that is further from the
clinician. As used herein, the term "subject" refers to a patient
that receives infusions or has blood and/or fluid collected
therefrom using the medical needle shield apparatus. According to
the present disclosure, the term "clinician" refers to an
individual administering an infusion, performing fluid collection,
installing or removing a needle cannula from a medical needle
shield apparatus and may include support personnel.
[0036] The following discussion includes a description of the
medical needle shield apparatus, followed by a description of the
method of operating the medical needle shield apparatus in
accordance with the present disclosure. Reference will now be made
in detail to the exemplary embodiments of the disclosure, which are
illustrated in the accompanying figures.
[0037] Turning now to the figures, wherein like components are
designated by like reference numerals throughout the several views.
Referring initially to FIGS. 1-8, there is illustrated a medical
needle shield apparatus including an extensible shield, such as,
for example, safety shield 10, constructed in accordance with the
principals of the present disclosure. Safety shield 10 is
advantageously configured to prevent hazardous exposure to a needle
cannula 15 by providing an adequate and reliable medical needle
shield apparatus for a needle infusion and/or fluid collection
device which shields a needle via one handed operation, as will be
discussed below.
[0038] Safety shield 10 is attached to a medical needle device,
such as, for example, prefilled syringe 11 to facilitate safe
infusion of fluids to a subject (not shown) from a sterile
cartridge or the like. Safety shield 10 may be attached to
prefilled syringe 11 via spin welding, adhesive, other welding
methods, etc. Alternatively, safety shield 10 may be
monolithically, integrally connected, etc. with the distal end of
prefilled syringe 11. Safety shield 10 is employed with a needle
cannula 15 supported by a needle hub 50 of prefilled syringe 11. It
is contemplated that a syringe employed may be prefilled with a
fluid, such as a pharmaceutical medication or may be a prefillable
syringe which is subsequently filled with a medication. It is
further contemplated that safety shield 10 may be used with other
fluid infusion, fluid collection, catheters, introducers, etc.,
similar to those described above.
[0039] Safety shield 10 includes a first segment, such as, for
example, proximal segment 14 and a second segment, such as, for
example, distal segment 16 extending therefrom. Distal segment 16
includes a circumferential wall, such as, for example, a cylinder
24. Cylinder 24 is disposed about needle cannula 15 and configured
to facilitate extension of safety shield 10 between a retracted
position (FIG. 1) and an extended position (FIG. 5), as will be
discussed.
[0040] Distal segment 16 defines a planar surface, such as, for
example, a base 32, discussed in more detail below, adjacent a
distal portion 52 thereof. Base 32 is configured to engage needle
cannula 15 for disposing safety shield 10 in the extended
position.
[0041] Thus, another advantage of the present disclosure is that
safety shield 10 is easily extendable via one handed activation,
resulting in a higher degree of safety to the clinician and
subject. Further, this configuration of safety shield 10
advantageously provides guided extension of the shield to reliably
prevent hazardous exposure to needle cannula 15 during
manipulation.
[0042] Safety shield 10 is desirably contemplated for use in the
field of medical fluid infusion and/or collection. More
particularly, safety shield apparatus 10 is envisioned to be a
disposable needle device employing, among other things, safety
features having shielding capabilities to prevent inadvertent
sticking or punctures of clinicians and subjects, as well as
uniform and dependable movement during a procedure and a locking
mechanism for reliable use. The above advantages, among others,
realized from the present disclosure are attained through the
disclosed safety shield 10, which is extensible to a protective
configuration, as discussed hereinbelow. These features of the
present disclosure advantageously facilitate a safe infusion and/or
collection of fluids and prevent inadvertent needle stick of a
clinician and subject.
[0043] Safety shield 10 is monolithically formed. It is
contemplated, however, that the component parts of safety shield 10
may be integrally assembled. Safety shield 10 can be fabricated
from a material suitable for medical applications, such as, for
example, polymerics or metals, such as stainless steel, depending
on the particular medical application and/or preference of a
clinician. Semi-rigid and rigid polymerics are contemplated for
fabrication, as well as resilient materials, such as molded medical
grade polypropylene. However, one skilled in the art will realize
that other materials and fabrication methods suitable for assembly
and manufacture, in accordance with the present disclosure, also
would be appropriate. Alternatively, portions of safety shield 10
can be monolithically formed and assembled therewith.
[0044] Proximal segment 14 is articulated to a collar 12 via a
hinged connection. It is contemplated that the hinged connection of
proximal segment 14 to collar 12 may be living hinges, pinned
hinges, etc., or alternatively, may be movably connected by other
structure, such as, ball joint, etc. As shown in FIGS. 5-8, a pair
of arms 54 extend to collar 12 and connect thereto via living
hinges 19. This configuration provides movement of proximal segment
14 relative to collar 12, facilitating extension of safety shield
10. It is envisioned that one or a plurality of hinged connections
may be used. Collar 12 is fixedly mounted to an outer surface of a
distal end of prefilled syringe 11, such as, for example, a luer
lock collar 38. Luer lock collar 38 is disposed about needle hub
50. Collar 12 may also be mounted directly to needle hub 50 or
various portions of prefilled syringe 11.
[0045] Referring to FIGS. 1, 2 and 5, collar 12 includes a pair of
latches 20 disposed for engagement with a corresponding pair of
catches 22 formed with distal segment 16. Cooperative engagement of
latches 20 and catches 22 releasably locks safety shield 10 in the
retracted position. Latches 20 have a female-type configuration for
releasably receiving catches 22 male-type component part in a snap
fit engagement. The releasable locking engagement provides a
tactile feel and audible signal that safety shield 10 is in the
retracted position.
[0046] To release safety shield 10 from the retracted position, a
manual actuator 18 provides an engagement surface for urging safety
shield 10 to the extended position and consequently disengaging
catches 22 from latches 20. It is envisioned that other releasable
engagements may be employed such as, for example, friction fit,
interference fit, etc., that the male/female components are
reversed, or, alternatively that no such releasable engagement is
used.
[0047] Distal segment 16 articulates from proximal segment 14 in a
hinged connection. It is contemplated that the hinged connection of
proximal segment 14 and distal segment 16 may be living hinges,
pinned hinges, etc., or alternatively, may be movably connected by
other structure, such as ball joint, etc. A pair of arms 56 extend
from proximal segment 14 to distal segment 16 for corresponding
connection via living hinges 19. This configuration provides
movement of distal segment 16 relative to proximal segment 14
facilitating extension of safety shield 10. It is envisioned that
one or a plurality of hinged connections may be used. Upon
engagement of manual actuator 18 with a clinician's hand, finger,
etc., or a table top, etc., safety shield 10 is urged from the
retracted position to the extended position for protecting a
sharpened tip 17 of needle cannula 15 after a medical
procedure.
[0048] Distal segment 16 includes cylinder 24 which defines an
opening 58. Opening 58 is transversely oriented relative to the
body of distal segment 16. Opening 58 is configured such that
cylinder 24 travels about needle cannula 15 to facilitate extension
of safety shield 10. Cylinder 24 and opening 58 provide a cavity to
accommodate needle cannula 15 such that segments 14, 16 uniformly
extend from the retracted position to the extended position via one
handed operation. This configuration advantageously maintains
safety shield 10 in alignment with needle cannula 15 during
extension thereof. It is contemplated that cylinder 24 may have
alternative configurations, such as, for example, rectangular,
elliptical, polygonal, etc., or cylinder 24 may have various
dimensions, according to the requirements of a particular medical
needle application.
[0049] Distal segment 16 includes a fulcrum 60, as shown in FIGS. 8
and 8A, disposed adjacent a proximal portion thereof to facilitate
extension of safety shield 10. Fulcrum 60 is configured to engage
needle cannula 15 to facilitate extension of segments 14, 16 from
the retracted position to the extended position. Fulcrum 60
includes a slot 62 configured to guide needle cannula 15 therein
during extension of safety shield 10. Slot 62 defines an opening
with walls 64, 65 which receive needle cannula 15 to maintain
safety shield 10 in alignment therewith. Walls 64, 65 are oriented
in a plane substantially transverse to longitudinal axis x. Wall 64
is oriented substantially orthogonal to walls 65. It is envisioned
that walls 64, 65 may be at various angular orientations relative
to longitudinal axis x. It is further envisioned that walls 64, 65
may be disposed at various angular orientations relative to each
other.
[0050] Needle cannula 15 engages wall 64 and wall 65 which serve as
a fulcrum and a guide to extend safety shield 10 into alignment
with longitudinal axis x of needle cannula 15. The resistive forces
created via engagement of wall 64 and needle cannula 15, and
continued manipulation of manipulable actuator 18 force such
extension of segments 14, 16. This configuration facilitates
extension of safety shield 10 via one handed operation. It is
contemplated that slot 62 may have other configurations such as,
for example, arcuate walls 64, 65, etc., or alternatively, may
define a larger or smaller opening, according to the requirements
of a particular medical needle application. It is further
contemplated that needle cannula 15 may engage only wall 64 or
walls 65.
[0051] A nose portion 28 of distal segment 16 projects from opening
58 of cylinder 24 and is in communication therewith via channel 36.
Nose portion 28 includes side walls 30 and base 32 that define a
cavity 34. Cavity 34 is configured for disposal of needle cannula
15 when safety shield 10 is in the extended position. Base 32
extends from cylinder 24 to the distal end of nose portion 28.
Channel 36 connects opening 58 and cavity 34 facilitating extension
of safety shield 10.
[0052] As segments 14, 16 extend about needle cannula 15, cylinder
24 travels about needle cannula 15. Needle cannula 15 is caused to
travel through cavity 34. As safety shield 10 approaches the
extended position, needle cannula 15 engages base 32. Base 32
forces segments 14, 16 to further extend and align with needle
cannula 15 along longitudinal axis x thereof to dispose safety
shield 10 in the extended position. In this position, needle
cannula 15 is protectively shielded by nose portion 28 and safety
shield 10 is disposed in the extended position. Safety shield 10
thereby prevents hazardous exposure to needle cannula 15 and needle
tip 17 thereof. This configuration advantageously protects a
clinician and subject from accidental needlestick via one handed
operation of safety shield 10. Base 32 may cover all or a portion
of the underside surface of nose portion 28.
[0053] Distal segment 16 includes a barbed flap lock 26 that
engages needle cannula 15 to fix safety shield 10 in the extend
position. As safety shield 10 approaches the extended position,
needle cannula 15 engages base 32. Needle cannula 15 is thereby
caused to engage lock 26 whereby lock 26 deflects about needle
cannula 15. Continued manipulation of safety shield 10, via manual
actuator 18, and corresponding engagement of needle cannula 15 and
base 32, causes needle cannula 15 to travel over a barbed portion
of lock 26 and come to rest on an opposite side thereof. Lock 26
returns to an undeflected position to non-releasably fix safety
shield 10 in the extended position. This provides an added degree
of security to the clinician and subject from accidental needle
stick. Alternatively, as shown in FIG. 11, proximal segment 14 has
a barbed flap lock 126, similar to lock 26, formed on an inner
surface thereof. Lock 126, either alone or in cooperation with lock
26, non-releasably fixes safety shield 10 in the extended position.
Other lock configurations are also envisioned.
[0054] In preparation for use of a medical needle shield apparatus,
similar to that described above, a medical needle shield, such as,
for example, safety shield 10 is assembled with a medical needle
device, such as, for example, prefilled syringe 11. The method of
assembly includes the steps of providing prefilled syringe 11 and
safety shield 10. Needle cannula 15 extends from prefilled syringe
11. A needle cover 40 is mounted to prefilled syringe 11 and
substantially encloses needle cannula 15. Opening 58 of safety
shield 10 is configured for clearance of needle cannula 15 during
attachment of safety shield 10 with prefilled syringe 11. As
discussed above, opening 58 is transversely oriented relative to
distal segment 16. It is envisioned that safety shield 10 is
provided for assembly with prefilled syringe 11 at the end of a
manufacturing process for syringe 11. Others arrangements are
contemplated such as introducing safety shield 10 at various stages
of manufacture of syringe 11.
[0055] Safety shield 10 is positioned for assembly with prefilled
syringe 11 such that needle cover 40 (FIGS. 9 and 10) and needle
cannula 15, substantially enclosed therein, travel through opening
58. It is contemplated that the component parts of the medical
needle shield apparatus may be manipulated for assembly by
personnel, mechanical devices, etc. It is further contemplated that
the inner surface of cylinder 24 may or may not engage needle cover
40 during positioning. Prefilled syringe 11 may or may not include
the needle cover.
[0056] Proximal segment 14 is disposed for mounting with prefilled
syringe 11. As discussed, proximal segment 14 includes collar 12.
Proximal segment 14 is mounted to an outer surface of prefilled
syringe 11, via collar 12, by way of the several mounting and
connection methods discussed above. This method of assembly for a
medical shield apparatus prevents disturbance of its component
parts and advantageously avoids contamination thereof, particularly
needle cannula 15, during manufacture.
[0057] In use, a medical needle shield apparatus similar to that
described above, employing safety shield 10 and prefilled syringe
11, is properly sterilized and otherwise prepared for storage,
shipment and use. As shown in FIGS. 9 and 10, a needle cover 40 is
used to protect needle cannula 15. Needle cover 40 shields, prior
to use and to prevent inadvertent unfolding or actuation, safety
shield 10.
[0058] Safety shield 10 is in the retracted position. After
completion of a medical procedure employing prefilled syringe 11,
actuator 18 is manipulated such that latches 20 and catches 22
disengage. As safety shield 10 is urged from the retracted position
to the extended position via one handed exertion on actuator 18,
opening 58 of cylinder 24 travels about needle cannula 15. Wall 64
of fulcrum 60 engages needle cannula 15 to extend segments 14,16
and guide movement thereof, as discussed.
[0059] Needle cannula 15 becomes positioned within cavity 34
through channel 36 to engage base 32. Continued pressure exerted on
actuator 18 and corresponding engagement of needle cannula 15 and
base 32 disposes safety shield 10 in the extended position. In the
extended position, nose portion 28 shields needle tip 17 in a
protective configuration to prevent hazardous exposure thereto,
providing security for a clinician and subject from accidental
needle stick. As safety shield 10 is disposed in the extended
position and needle cannula 15 and base 32 engage, lock 26 engages
needle cannula 15 to non-releasably fix safety shield 10 in the
protective configuration, as discussed.
[0060] The invention of the present disclosure may be embodied in
other specific forms without departing from the spirit or essential
characteristics thereof. The present embodiments are therefore to
be considered in all respects as illustrative and not restrictive,
the scope of the invention being indicated by the appended claims
rather than by the foregoing description, and all changes which
come within the meaning and range of equivalency of the claims are
therefore intended to be embraced therein.
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