U.S. patent application number 11/194870 was filed with the patent office on 2005-12-01 for blood collection assembly.
This patent application is currently assigned to Becton, Dickinson and Company. Invention is credited to Swenson, Kirk D., Wilkinson, Bradley M..
Application Number | 20050267412 11/194870 |
Document ID | / |
Family ID | 23214143 |
Filed Date | 2005-12-01 |
United States Patent
Application |
20050267412 |
Kind Code |
A1 |
Wilkinson, Bradley M. ; et
al. |
December 1, 2005 |
Blood collection assembly
Abstract
A low cost shieldable safety needle assembly. The assembly
includes a needle cannula and a tip guard axially movable along the
needle cannula through a drive mechanism. The drive mechanism may
be interconnected between the tip guard and the needle cannula
through a hub. The tip guard is axially movable along the needle
cannula from a proximal position substantially adjacent a proximal
end of the needle cannula at the hub, to a distal position in which
the tip guard protectively surrounds the distal end of the needle
cannula, thus effectively shielding the puncture tip of the needle.
The drive mechanism is a unitary structure which is capable of
maintaining a first self-supporting shape for maintaining the tip
guard in the proximal position and is deflectable from the first
self-supporting shape to a second extended shape in which the tip
guard is moved to the distal position. The drive mechanism may be a
rigid flexible planar sheet material which includes a plurality of
folds for defining the self-supporting shape. The needle assembly
may include structure for mating with a hypodermic syringe, a blood
collection set, or other medical device.
Inventors: |
Wilkinson, Bradley M.;
(North Haledon, NJ) ; Swenson, Kirk D.; (North
Caldwell, NJ) |
Correspondence
Address: |
DAVID W. HIGHET, VP AND CHIEF IP COUNSEL
BECTON DICKINSON AND COMPANY
[THE WEBB LAW FIRM]
FRANKLIN LAKES
NJ
07414-1880
US
|
Assignee: |
Becton, Dickinson and
Company
|
Family ID: |
23214143 |
Appl. No.: |
11/194870 |
Filed: |
August 1, 2005 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
11194870 |
Aug 1, 2005 |
|
|
|
10219372 |
Aug 15, 2002 |
|
|
|
6936036 |
|
|
|
|
60313047 |
Aug 17, 2001 |
|
|
|
Current U.S.
Class: |
604/110 ;
128/919; 604/263 |
Current CPC
Class: |
A61B 5/150564 20130101;
A61B 5/150717 20130101; A61B 5/150587 20130101; A61B 5/150519
20130101; A61B 5/15003 20130101; A61B 5/15074 20130101; A61B
5/150656 20130101; A61B 5/153 20130101; A61B 5/150732 20130101;
A61M 2005/325 20130101; A61B 5/150389 20130101; A61M 5/3275
20130101 |
Class at
Publication: |
604/110 ;
128/919; 604/263 |
International
Class: |
A61M 005/00 |
Claims
What is claimed:
1. A shieldable needle device comprising: a needle cannula having
opposed proximal and distal ends; a tip guard axially movable along
said needle cannula from a proximal position substantially adjacent
said proximal end of said needle cannula to a distal position where
said tip guard protects said distal end of said needle cannula from
exposure; and a drive mechanism connected to said tip guard for
moving said tip guard from said proximal position to said distal
position, said drive mechanism comprising a unitary structure
capable of maintaining a first self-supporting shape in which said
unitary structure includes a plurality of folds with at least two
of said folds intersecting each other to form a trigger, said drive
mechanism maintaining said tip guard in said proximal position when
said unitary structure is in said first self-supporting shape, said
unitary structure being deflectable from said first self-supporting
shape to a second extended shape in which said tip guard is moved
to said distal position when a force is applied to said trigger,
thereby causing said plurality of folds to at least partially
unfold.
2. A needle device as in claim 1, wherein said unitary structure
comprises a rigid flexible planar sheet material including a
plurality of folds.
3. A needle device as in claim 1, further comprising a hub mounted
to said proximal end of said needle cannula, said drive mechanism
interconnecting said hub and said tip guard.
4. A needle device as in claim 1, wherein said drive mechanism is
in the form of a dorsal fin extending along said needle device when
said unitary structure is in said first self-supporting shape.
5. A shieldable needle device comprising: a) a needle cannula
having opposed proximal and distal ends; b) a hub mounted adjacent
said proximal end of said needle cannula; c) a tip guard axially
movable along said needle cannula from a proximal position
substantially adjacent said hub to a distal position where said tip
guard protects said distal end of said needle cannula from
exposure; and d) a drive mechanism for moving said tip guard from
said proximal position to said distal position, said drive
mechanism comprising a planar material interconnected between said
hub and said tip guard, said planar material including a plurality
of folds defining a dorsal fin structure with at least two of said
folds intersecting each other to form a trigger point, said trigger
point and said plurality of folds interrelating for movement of
said tip guard from said proximal position to said distal position
upon activation of said at least one trigger point.
6. A needle device as in claim 5, wherein said planar material
comprises a rigid flexible material.
7. A needle device as in claim 6, wherein said planar material
comprises paper.
8. A needle device as in claim 6, wherein said planar material
comprises a plastic material.
9. A needle device as in claim 8, wherein said plastic material is
polypropylene.
10. A needle device as in claim 5, wherein said dorsal fin
structure is a self-supporting structure.
11. A needle device as in claim 5, wherein external pressure
exerted on said trigger point causes at least one of said plurality
of folds to unfold and act as a hinge, thereby activating said
drive mechanism and causing said tip guard to move to said distal
position.
12. A needle device as in claim 5, wherein said tip guard comprises
a tip guard housing formed from a plastic material, a metallic
spring clip being mounted to said housing, said spring clip being
biased against said needle cannula when said tip guard is in said
proximal position and being resiliently moved over said distal end
of said needle cannula when said tip guard is in said distal
position.
13. A needle device as in claim 5, wherein said hub is adapted for
connection to a flexible tube of a blood collection set.
14. A needle device as in claim 5, wherein said hub further
includes means for attachment with a hypodermic syringe.
15. A shieldable double ended needle assembly comprising: a hub
including a proximal end and a distal end and an internal passage
extending therethrough; a needle cannula extending through the
internal passage of said hub, said needle cannula including a
distal end with an intravenous puncture tip projecting from said
distal end of said hub and a proximal end with a non-patient
puncture tip projecting from said proximal end of said hub; a tip
guard axially movable along said needle cannula from a proximal
position substantially adjacent said hub to a distal position
surrounding said intravenous puncture tip at said distal end of
said needle cannula; and a drive mechanism for moving said tip
guard from said proximal position to said distal position, said
drive mechanism comprising a planar material securely
interconnected between said hub and said tip guard, said planar
material including a plurality of folds with at least two of said
folds intersecting each other to form at least one trigger point
for activation of said drive mechanism, wherein external pressure
exerted on said trigger point causes at least one of said plurality
of folds to unfold and act as a hinge, thereby causing said drive
mechanism to move said tip guard from said proximal position to
said distal position.
16. A needle assembly as in claim 15, wherein said proximal end of
said hub includes means for attachment with a needle holder.
17. A needle assembly as in claim 16, wherein said means comprises
threads.
18. A needle assembly as in claim 15, further comprising a
packaging cover extending over the distal end of the needle
cannula.
19. A needle assembly as in claim 18, further comprising a second
packaging cover extending over the proximal end of the needle
cannula.
Description
CROSS-REFERENCE TO RELATED APPLICATIONS
[0001] This application is a continuation of U.S. application Ser.
No. 10/219,372 filed Aug. 15, 2002, which claims priority to U.S.
Provisional Application Ser. No. 60/313,047 filed Aug. 17, 2001,
entitled "Blood Collection Set" and which are incorporated herein
by reference.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to safety needle assemblies
for safe and convenient handling of needles. More particularly, the
present invention relates to a low cost needle assembly having a
safety shield.
[0004] 2. Description of Related Art
[0005] Disposable medical devices having piercing elements are
typically used for administering a medication or withdrawing a
fluid, such as hypodermic syringes, blood collecting needles, fluid
handling needles and assemblies thereof. Current medical practice
requires that the fluid containers and needle assemblies used in
such systems be inexpensive and readily disposable. Safe and
convenient handling of disposable medical devices results in the
disposal of the medical devices intact.
[0006] For example, existing blood collection systems typically
employ some form of durable, reusable holder on which detachable
and disposable needles and fluid collection tubes may be mounted. A
blood collection system of this nature can be assembled prior to
use and then disassembled after usage. Thus, these blood collection
systems allow repeated use of the relatively expensive holder upon
replacement of the relatively inexpensive needle and/or fluid
collection tube. In addition to reducing the cost of collecting
blood specimens, these blood collection systems also help minimize
the production of hazardous medical waste. A blood collection set
or intravenous (IV) infusion set typically includes a needle
cannula having a proximal end, a pointed distal end and a lumen
extending therebetween. The proximal end of the needle cannula is
securely mounted in a plastic hub with a central passage that
communicates with the lumen through the needle cannula. A thin
flexible thermoplastic tube is connected to the hub and
communicates with the lumen of the needle cannula. The end of the
plastic tube remote from the needle cannula may include a fixture
for connecting the needle cannula to a blood collection tube or
some other receptacle. The specific construction of the fixture
will depend upon the characteristics of the receptacle to which the
fixture will be connected.
[0007] In order to reduce the risk of incurring an accidental
needle-stick wound, protection of used needle tips becomes
important. With concern about infection and transmission of
diseases, methods and devices to enclose the used disposable needle
have become very important and in great demand. For example, needle
assemblies commonly employ a safety shield that can be moved into
shielding engagement with a used needle cannula without risking an
accidental needle stick.
[0008] Some needle shields are referred to as tip guards, and
include a small rigid guard that can be telescoped along the length
of a needle cannula and extended over the puncture tip of the
needle for protection. Such conventional tip guard may include some
form of tether for limiting the travel of the tip guard to the
length of the needle cannula. Additionally, such conventional tip
guard typically includes structure that lockingly engages over the
tip of the used needle cannula to prevent a re-exposure of the
needle. The structure for preventing re-exposure may include a
metallic spring clip or a transverse wall integrally formed with
one end of the tip guard. Needle assemblies including such tip
guards, however, typically include extensive mechanics for
positioning of the tip guard, resulting in complex arrangements
which are costly to manufacture and assembly. Also, operation of
the tip guard can involve substantial manipulation by the user to
extend the tip guard to a shielding position.
[0009] Accordingly, a need exists for a needle assembly for use
with disposable medical devices, such as a blood collection set,
which achieves secure and effective shielding of a used needle tip
and which is simple and inexpensive to manufacture and easy to
operate.
SUMMARY OF THE INVENTION
[0010] The present invention is directed to a shieldable needle
device, particularly useful in connection with a blood collection
set. The needle device includes a needle cannula having opposed
proximal and distal ends and a tip guard axially movable along the
needle cannula from a proximal position substantially adjacent the
proximal end of the needle cannula to a distal position where the
tip guard protectively surrounds the distal end of the needle
cannula. A drive mechanism is connected to the tip guard for moving
the tip guard from the proximal position to the distal position.
The drive mechanism is a unitary structure capable of maintaining a
first self-supporting shape for maintaining the tip guard in the
proximal position, and is deflectable from the first
self-supporting shape to a second extended shape in which the tip
guard is moved to the distal position. Desirably, the drive
mechanism is a unitary structure of a rigid flexible planar sheet
material, such as paper or plastic, which including a plurality of
folds.
[0011] The needle device may include a hub mounted to the proximal
end of the needle cannula, with the drive mechanism interconnecting
the hub and the tip guard. Desirably, the drive mechanism is in the
form of a dorsal fin extending along the needle device.
[0012] The present invention is also directed to a shieldable
needle device which includes a needle cannula having opposed
proximal and distal ends, a hub mounted to the proximal end of the
needle cannula, and a tip guard axially movable along the needle
cannula from a proximal position substantially adjacent the hub to
a distal position, in which the tip guard protectively surrounds
the distal end of the needle cannula, such as a puncture tip. The
needle device further includes a drive mechanism for moving the tip
guard from the proximal position to the distal position. The drive
mechanism includes a planar material interconnected between the hub
and the tip guard, desirably a rigid flexible material such as a
sheet of paper or polypropylene plastic, folded into the form of a
dorsal fin extending along the needle device. The planar material
has a plurality of folds for providing the drive mechanism with at
least one trigger and at least one hinge. The trigger and the
hinges interrelate to deflect the drive mechanism for movement of
the tip guard from the proximal position to the distal position
upon activation of the trigger. For example, external pressure
exerted on the trigger causes at least one of the plurality of
folds to unfold and act as a hinge, thereby activating the drive
mechanism and causing the tip guard to move to the distal
position.
[0013] The tip guard may include a tip guard housing formed from a
plastic material and a metallic spring clip mounted to the housing.
The spring clip may be biased against the needle cannula when the
tip guard is in the proximal position, and may be resiliently moved
over the distal end of the needle cannula when the tip guard is in
the distal position. Moreover, the hub may be adapted for
connection to a flexible tube of a blood collection set.
[0014] In a further embodiment, the present invention is directed
to a shieldable blood collection set which includes a fixture for
connecting the blood collection set to a receptacle; a flexible
tube having opposed first and second ends, with the first end of
the flexible tube being connected to the fixture; a hub mounted to
the second end of the flexible tube; a needle cannula having a
proximal end connected to the hub, a distal end projecting from the
hub and a lumen in fluid communication with the tube and the
fixture; a tip guard axially movable along the needle cannula from
a proximal position substantially adjacent the hub to a distal
position surrounding the distal end of the needle cannula; and a
drive mechanism for moving the tip guard from the proximal position
to the distal position. The drive mechanism includes a planar
material securely interconnected between the hub and the tip guard,
with the planar material including a plurality of folds forming at
least one trigger for activation of the drive mechanism and at
least one hinge capable of moving the tip guard from the proximal
position to the distal position. External pressure exerted on the
trigger causes at least one of the plurality of folds to unfold and
act as a hinge, thereby activating the drive mechanism and causing
the tip guard to move to the distal position.
DESCRIPTION OF THE DRAWINGS
[0015] FIG. 1 is a perspective view of a blood collection set in
accordance with the present invention;
[0016] FIG. 2 is an exploded perspective view of the shieldable
needle assembly of the blood collection set of FIG. 1;
[0017] FIG. 3 is a top plan view of the shieldable needle assembly
in a retracted position;
[0018] FIG. 4 is a cross-sectional view taken along line 4-4 of
FIG. 3;
[0019] FIG. 5 is a perspective view of the fully assembled blood
collection set with a packaging cover thereon;
[0020] FIG. 6 is a top plan view of the shieldable needle assembly
in an extended shielded position;
[0021] FIG. 7 is a cross-sectional view taken along line 7-7 of
FIG. 6;
[0022] FIG. 8 is a top plan view of a planar sheet material
depicting a fold pattern for forming one embodiment of a drive
mechanism for use in the blood collection set of the present
invention;
[0023] FIG. 9 is a perspective view of an alternate tip guard
assembly for use in connection with the present invention;
[0024] FIG. 10 is an exploded perspective view of the shieldable
needle assembly including the alternate tip guard assembly of FIG.
9; and
[0025] FIG. 11 is cross-sectional view of the shieldable needle
assembly of FIG. 10 in an extended shielded position including the
alternate tip guard of FIG. 9;
[0026] FIG. 12 is a perspective view of a needle assembly for
attachment to a syringe in accordance with a further embodiment of
the present invention;
[0027] FIG. 13 is a perspective view of a double ended needle
assembly for attachment to a needle holder in accordance with a
further embodiment of the present invention; and
[0028] FIG. 14 is an exploded perspective view of the double ended
needle assembly of FIG. 13 with the needle covers removed and shown
with a needle holder.
DETAILED DESCRIPTION
[0029] Referring to the drawings in which like reference characters
refer to like parts throughout the several views thereof, FIGS. 1
and 5 illustrate a shieldable needle assembly, for use in
connection with a blood collection set, in accordance with the
present invention and the related features. The present invention
is generally described in terms of a shieldable needle assembly,
and encompasses a shieldable needle assembly as well as such a
shieldable needle assembly for use with a medical device such as a
blood collection set, a hypodermic syringe, a double ended needle
assembly for blood collection, and the like. FIGS. 1 and 5
illustrate the shieldable needle assembly in the form of a blood
collection set 10, including a shieldable needle device 12. While
described in FIGS. 1-5 in terms of one embodiment of a blood
collection set, the shieldable needle device of the present
invention may incorporate other medical devices used in connection
with a needle, such as a hypodermic syringe assembly, a hypodermic
needle, a double ended needle assembly for blood collection, an
intravenous infusion set, or other fluid handling devices or
medical device assemblies that contain piercing elements.
[0030] As shown in FIGS. 1 and 5, blood collection set 10 includes
a shieldable needle device 12, a flexible tube 14 extending from
needle device 12, a fixture 16 mounted to tube 14 and a packaging
cover 18 removably mounted to portions of needle device 12 opposite
tube 14, such as through a frictional engagement. Shieldable needle
device 12 of blood collection set 10 is shown in detail in FIGS.
2-4, and includes a needle cannula 20, a hub 30, a tip guard
assembly 50 and a deflectable drive mechanism 80.
[0031] Needle cannula 20 includes a proximal end 22 and an opposing
distal end 24, with lumen 26 extending through needle cannula 20
from proximal end 22 to distal end 24. Distal end 24 of needle
cannula 20 is beveled to define a sharp puncture tip 28, such as an
intravenous puncture tip. Puncture tip 28 is provided for insertion
into a patient's blood vessel, such as a vein, and is therefore
designed to provide ease of insertion and minimal discomfort during
venipuncture.
[0032] Needle assembly 12 further includes hub 30. Hub 30 is a
unitary structure, desirably molded from a thermoplastic material.
Hub 30 includes a proximal end 32, a distal end 34, and is defined
by a rigid tubular wall 36 extending from proximal end 32 to distal
end 34. Tubular wall 36 is characterized by an internal passage 38
extending therethrough from proximal end 32 to distal end 34 of hub
30. Hub 30 further includes a pair of stabilizers 40 extending
along tubular wall 36 at opposing sides thereof. Stabilizers 40
provide hub 30, and needle assembly 12, as a butterfly-type wing
assembly, assisting in positioning and placement of needle assembly
12 and blood collection set 10 during a blood collection
procedure.
[0033] Needle cannula 20 is positioned within internal passage 38
of hub 30, and extends from distal end 34 of hub 30. Desirably,
needle cannula 20 and hub 30 are separate parts which are fixedly
attached and secured through an appropriate medical grade adhesive
or the like.
[0034] Needle assembly 12 further includes tip guard assembly 50,
which is movable along needle cannula 20 between a first proximal
position adjacent hub 30, and a second distal position adjacent
puncture tip 28, as will be described in more detail herein. Tip
guard assembly 50 includes a housing 52 and a protective clip 60.
Housing 52 is a unitary structure, desirably molded from a
thermoplastic material, including a proximal end 54, a distal end
56, and an internal passage 58 extending between the ends. Portions
of internal passage 58 adjacent distal end 56 define an enlarged
clip receptacle 62, as shown in FIG. 4. A clip mounting post 64
extends downwardly from housing 52 at a location near proximal end
54 of housing 52.
[0035] Clip 60 is unitarily stamped and formed from a resiliently
deflectable metallic material. Clip 60 includes a planar spring leg
66 with a proximal end 68 and an opposed distal end 70. A mounting
aperture 72 extends through spring leg 66 at a location near
proximal end 68. Mounting aperture 72 has a diameter approximately
equal to or slightly less than the diameter of mounting post 64 of
housing 52. As such, mounting post 64 can be forced through
mounting aperture 72 when the axis of mounting post 64 and the axis
of mounting aperture 72 are substantially collinear. A lock out leg
74 extends angularly from distal end 70 of spring leg 66. Lock out
leg 74 is bent back toward proximal end 68 of clip 60. The bends in
lock out leg 74 enable secure protective engagement with puncture
tip 28 of needle cannula 20 and further enable smooth axial sliding
movement of tip guard assembly 50 along needle cannula 20 as
described in further detail herein.
[0036] Hub 30 and tip guard assembly 50 are interconnected through
drive mechanism 80. Drive mechanism 80 provides for axial movement
of tip guard assembly 50 along needle cannula 20 from a first
proximal position adjacent hub 20 to a second distal position
adjacent puncture tip 28, as will be described in more detail
herein. Drive mechanism 80 is a unitary structure of a planar sheet
material 82, as shown in FIG. 8. Planar sheet 82 includes a
plurality of folds 84 in a patterned arrangement to form drive
mechanism 80 in a first shape, which is adapted to maintain tip
guard assembly 50 in the first proximal position adjacent hub 20.
Moreover, folds 84 of planar sheet 82 further provide drive
mechanism 80 with the ability to deflect from such a first shape to
a second extended shape, in which tip guard assembly 50 is moved to
a second distal position adjacent puncture tip 28.
[0037] Planar sheet 82 of drive mechanism 80 is desirably
constructed of a material which is a rigid flexible material. More
particularly, a rigid flexible material is defined in terms of the
present invention as a material which is sufficiently rigid to
maintain a desired self-supporting shape when folded, for example
along folds 84, yet is sufficiently flexible to deflect from such a
desired self-supporting shape with at least some of the folds
unfolding, to provide a second shape different from the first
shape. Examples of materials which are rigid yet flexible in this
manner include paper and plastic, for example, polypropylene,
formed into a planar sheet.
[0038] Planar sheet 82 can be folded along folds 84 as shown in
FIG. 8, to form a shape as shown in FIGS. 1-5. Such a folded
structure is shaped in the form of a dorsal fin extending along the
top of needle device 12 of blood collection set 10. Such a shape
provides drive mechanism 80 with a first portion 88 which is
adapted for attachment to tip guard assembly 50, and a second
portion 90 which is adapted for attachment to hub 30. First portion
88 is desirably a folded portion of planar sheet 82 which is
fixedly adhered to a top portion of housing 52 of tip guard
assembly 50, such as through an adhesive or the like. Similarly,
second portion 90 may be a folded portion of planar sheet 82, such
as flaps 92 depicted in FIG. 8, which are fixedly adhered to
tubular wall 36 of hub 30, desirably at the top portion of tubular
wall 36. As such, drive mechanism 80 interconnects hub 30 and tip
guard assembly 50. Further, the folded structure of drive mechanism
80 provides a first, self-supporting shape, which maintains tip
guard assembly 50 in a first proximal position adjacent hub 20.
[0039] Moreover, the rigid flexible material of planar sheet 82
allows for planar sheet 82 to deflect from this first shape into a
second shape. For example, folds 84 of planar sheet 82, which
define the shape of the folded structure of drive mechanism 80 in
the form of a dorsal fin, also provide drive mechanism 80 with a
juncture of a plurality of folds 84, such as trigger 86 at the top
portion thereof. External pressure exerted on trigger 86 in a
direction of arrow 100, such as through a user's index finger,
activates drive mechanism 80 and causes at least some of folds 84
of drive mechanism 80 to partially or fully unfold, thereby acting
as a hinge. Unfolding of folds 84 in this manner results in a
biasing force exerted between first portion 88 and second portion
90 of drive mechanism 80 in opposing directions with respect to
each other. Since second portion 90 of drive mechanism 80 is
fixedly attached to hub 30 and hub 30 is stationary with respect to
needle device 12 and flexible tube 14, second portion 90 of drive
mechanism 80 remains in a fixed location. Since first portion 88 of
drive mechanism 80 is fixedly attached to tip guard assembly 50 and
since tip guard assembly 50 is axially movable along needle cannula
20, such biasing force of first portion 88 and second portion 90 in
opposing directions causes tip guard assembly to axially move in
the direction of arrow 102 away from hub 30 and toward distal end
24 of needle cannula 20, where tip guard assembly 50 can
effectively shield puncture tip 28.
[0040] Tip guard assembly 50 moves axially along needle cannula 20
toward distal end 24 during the deflection of drive mechanism 80
between the first shape and the second shape. Such deflection of
drive mechanism 80 is provided for through the plurality of folds
84, which form at least one, and more desirably a plurality of
living hinges for drive mechanism 80. These living hinges are
capable of maintaining drive mechanism 80 in the first shape which
is self-supporting, and are capable of unfolding into the second
shape. The unique shape and configuration of drive mechanism 80
also results in drive mechanism 80 being capable of unfolding into
a low profile flat shape, in addition to providing for axial
movement of tip guard assembly 50 upon activation of trigger 86
through exertion of force in a direction of arrow 100.
[0041] Planar sheet 82 of drive mechanism 80 may further include a
material which is capable of adding flexible memory to drive
mechanism 80. In particular, a metallic or plastic portion may be
associated with planar sheet 82, to provide planar sheet 82 with
potential energy to allow for planar sheet 82 to deflect from the
first shape into the second shape. Such a material may desirably be
integral with the entire surface of planar sheet 82, or may be
integral with a portion of planar sheet 82, such as a portion of
planar sheet 82 at one or more folds 84. For example, a metallic or
plastic portion may be laminated to a portion of planar sheet 82,
with the metallic or plastic portion providing the rigid
flexibility to planar sheet 82.
[0042] Assembly of blood collection set 10 is accomplished by
folding planar sheet 82 along folds 84 and forming into the shape
of a dorsal fin to provide drive mechanism 80. First portion 88 of
drive mechanism 80 is fixedly adhered to tip guard housing 52, and
second portion 90 of drive mechanism 80 is fixedly adhered to hub
20. Tip guard assembly 50 is assembled by forcing mounting post 64
of tip guard housing 52 through mounting aperture 72 of clip 60.
Spring leg 66 of clip 60 is then urged downwardly or away from
internal passage 58 through tip guard housing 52. Distal end 22 of
needle cannula 20 is then passed through internal passage 38 of hub
30, and urged into internal passage 58 at proximal end 54 of tip
guard housing 52. The downward deflection of spring leg 66 enables
distal end 24 of needle cannula 20 to be passed entirely through
tip guard housing 52. Spring leg 66 can be released after puncture
tip 28 of needle cannula 20 passes entirely through tip guard
housing 20. Thus, the end of lock out leg 74 will be biased against
and slide along needle cannula 20. Tip guard assembly 50 then is
slid proximally along needle cannula 20 into a position adjacent
hub 22. Packaging cover 18 is then urged over puncture tip 28 and
urged proximally over needle cannula 20, with puncture tip 28
safely maintained and disposed within packaging cover 18.
[0043] Blood collection set 10 can be packaged substantially in the
condition shown in FIG. 5, with drive mechanism 80 in a folded
state. Prior to use, blood collection set 10 is removed from its
package. Fixture 16 then may be connected to an appropriate
receptacle for providing fluid communication with lumen 26 through
needle cannula 20.
[0044] In use, blood collection set 10 is provided with needle
device 12 assembled and including flexible tube 14 extending from
needle device 12 and connected to fixture 16. After removing blood
collection set 10 from its package, it can be assembled with other
appropriate medical equipment for use. For example, a non-patient
needle assembly and a needle holder may be connected to blood
collection set 10 through fixture 16.
[0045] To prepare for use of blood collection set 10, the user
grasps blood collection set 10 at needle device 12, holding drive
mechanism 80 in a folded state to ensure that tip guard assembly 50
is maintained adjacent hub 30. Packaging cover 18 is then grasped
and urged distally to disengage from needle cannula 20, thereby
exposing puncture tip 28 of needle cannula 20.
[0046] The medical practitioner can then urge puncture tip 28 at
distal end 24 of needle cannula 20 into a targeted blood vessel of
a patient, while drive mechanism 80 is maintained in a folded
state, between thumb and forefinger to assist in controlled entry
by the medical practitioner. Stabilizers 40 are maintained flush
against the patient's skin during such procedure, thereby ensuring
that needle device 12 is inserted in the proper orientation within
the vessel. After the targeted blood vessel has been accessed, the
medical practitioner can release the grip on drive mechanism 80.
Drive mechanism 80 maintains its shape, with tip guard assembly 50
held adjacent hub 30.
[0047] An appropriate medical procedure can then be conducted. Upon
completion of the procedure, such as when all desired samples have
been drawn, needle cannula 20 is withdrawn from the patient, and
activation of the safety feature of needle device 12 can be
accomplished.
[0048] To activate the safety feature, trigger 86 of drive
mechanism 80 is activated by exerting pressure in a direction of
arrow 100, such as by pushing on the point at the common juncture
of folds 84 at the top of drive mechanism 80. Such force unfolds
some or all of folds 84, thereby deflecting drive mechanism 80 from
a first folded shape to a second unfolded shape. During such
unfolding of drive mechanism 80, tip guard assembly 50 is forced in
an axial direction of arrow 102 and slides or glides along needle
cannula 20 toward distal end 24.
[0049] After tip guard assembly 50 is moved along needle cannula 20
to the distal end 24, lockout leg 74 of clip 60 will pass distally
beyond puncture tip 28 of needle cannula 20. The inherent
resiliency of spring leg 66 of clip 60 will urge lockout leg 74
over puncture tip 28 of needle cannula 20. Thus, a return movement
of tip guard assembly 50 is prevented. Furthermore, planar sheet 82
of drive mechanism 80 has an overall dimension that will prevent
movement of tip guard assembly 50 distally beyond needle cannula
20. Hence, puncture tip 28 of needle cannula 20 is safely shielded.
Furthermore, inadvertent contact with portions of needle cannula 20
between the opposed ends is substantially prevented by the overall
dimensions of drive mechanism 80 in an unfolded state at least
partially encompassing needle cannula 20. Blood collection set 10
may then be appropriately discarded.
[0050] It is noted that activation of the safety feature may be
accomplished while venipuncture is maintained, that is while
puncture tip 28 of needle cannula 20 is maintained within the blood
vessel of the patient. For example, trigger 86 can be activated
while puncture tip 28 is within the patient's blood vessel, thereby
axially moving tip guard assembly 50 axially along needle cannula
20. Since puncture tip 28 is within the patient's blood vessel,
such distal movement of tip guard assembly 50 will terminate when
tip guard housing 52 contacts the skin of the patient near the
puncture site. Upon removal of puncture tip 28 from the patient's
blood vessel, tip guard assembly 50 will continue in it's axial
movement toward the distal end 24 of needle cannula 20 due to the
bias exerted through folds 84 of drive mechanism 80. Such axial
movement results in lockout leg 74 being urged over puncture tip 28
of needle cannula 20, thereby shielding puncture tip 28 of needle
cannula 20.
[0051] FIGS. 9-14 depict further embodiments of the invention that
includes many components which are substantially identical to the
components of FIGS. 1-8. Accordingly, similar components performing
similar functions will be numbered identically to those components
of FIGS. 1-8, except that a suffix "a" will be used to identify
those similar components in FIGS. 9-11, a suffix "b" will be used
to identify those similar components in FIG. 12, and a suffix "c"
will be used to identify those similar components in FIGS.
13-14.
[0052] In an alternate embodiment of the present invention, tip
guard assembly 50a may be provided as a one component tip guard
assembly, as depicted in FIGS. 9-11. More particularly, as shown in
FIG. 9, alternate tip guard assembly 50a is movable along needle
cannula 20a between a first proximal position adjacent hub 30a, and
a second distal position adjacent puncture tip 28a, in a similar
manner as with tip guard assembly 50 described above in connection
with the embodiments of FIGS. 1-8. Tip guard assembly 50a includes
proximal end 54a and distal end 56a, with top extent 46a defining
the top portion of tip guard assembly 50a and extending
longitudinally along a portion of needle cannula 20a between
proximal end 54a and distal end 56a. Top extent 46a bends
downwardly at distal end 56a to form front end wall 48a. At
proximal end 54a, top extent 46a bends backward to form spring leg
66a which extends back toward the distal end 56a of tip guard
assembly 50a, with lock out leg 74a bending upward and backward to
form an end wall, as seen in FIGS. 9-11. Proximal end 54a of tip
guard assembly 50a includes proximal opening 76a, while distal end
56a of tip guard assembly 50a includes distal opening 78a extending
through front end wall 48a. Proximal opening 76a and distal opening
78a are provided for accommodating needle cannula 20a extending
therethrough.
[0053] As with the embodiment described in connection with FIGS.
1-8, tip guard assembly 50a is interconnected with hub 30a through
drive mechanism 80a, with first portion 88a of drive mechanism 80a
attached to top extent 46a of tip guard assembly 50a. Tip guard
assembly 50a is movable between a proximal position substantially
adjacent hub 30a, and a distal position, in which tip guard
assembly 50a protectively surrounds puncture tip 28a of needle
cannula 20a, as described above. In the proximal position, needle
cannula 20a extends through proximal opening 76a and distal opening
78a, with spring leg 66a biased against needle cannula 20a. During
unfolding of drive mechanism 80a as discussed above, tip guard
assembly 50a slides or glides along needle cannula 20a toward
distal end 24a, in a similar manner as discussed above. As shown in
FIG. 11, distal opening 78a and lock out leg 74a pass distally
beyond puncture tip 28a, and the inherent resiliency of spring leg
66a urges lock out leg 74a over puncture tip 28, preventing a
return movement, and thus preventing re-exposure of puncture tip
28.
[0054] While the needle assembly of the present invention has been
described in terms of an embodiment for use in connection with a
blood collection system, it is further contemplated that the needle
assembly could be used with other medical procedures, such as in
conjunction with a conventional intravenous infusion set, a
hypodermic needle assembly, or a double ended needle assembly for
blood collection, all of which are well known in the art for use
with needle assemblies.
[0055] For example, FIG. 12 depicts safety needle device 12b for
attachment to conventional medical devices, such as conventional
needle holders for blood collection, syringes, and the like. As
shown in FIG. 12, the safety needle device 12b includes a needle
cannula 20b, a hub 30b, and a tip guard assembly 80b, as set forth
in the embodiment described above. In the embodiment of FIG. 12,
the safety needle device 12b is an independent component for
attachment to a medical device. As such, hub 30b acts as a base hub
for providing such attachment.
[0056] Accordingly, hub 30b includes means for attachment with a
medical device, such as a hypodermic syringe, at proximal end 32b.
For example, hub 30b may include a threaded end at the proximal end
thereof. Desirably, as shown in FIG. 12, hub 30b includes a female
luer fitting 104 and a luer flange 106 at the proximal end thereof.
Such an arrangement provides for attachment with a luer fitting,
and may include additional luer lugs for attachment with a luer
collar, such as a syringe luer collar. Such a luer fitting enables
safety needle device 12b to be sold as a sterile needle assembly
for use with a conventional medical device adapted for use with a
luer fitting, such as a hypodermic syringe.
[0057] In a further embodiment depicted in FIGS. 13 and 14, safety
needle device 12c is provided as an independent component in the
form of a double ended needle assembly for attachment to a needle
holder, as is known for use in connection with blood sampling
procedures. In the needle device 12c depicted in FIGS. 13 and 14,
needle cannula 20c is in the form of a double ended needle,
including puncture tip 28c as an intravenous puncture tip at distal
end 24c thereof, and a non-patient puncture tip 110c at proximal
end 22c thereof. Needle cannula 20c extends through hub 30c.
Proximal end 22c of needle cannula 20c desirably includes an
elastomeric sleeve 112c covering non-patient puncture tip 110c.
[0058] Hub 30c desirably includes means for attachment to a needle
holder 118. For example, hub 30c may include a threaded end 114c at
the proximal end 32c thereof. Preferably, threaded end 114c
comprises male threads 116c for mounting needle device 12c on
needle holder 118c. As needle device 12c is provided as an
independent component for attachment to a separate needle holder,
needle device 12c is desirably packaged as shown in FIG. 13,
including packaging cover 18c covering distal end 24c of needle
cannula 20c, and further including a second packaging cover 120c
covering proximal end 22c of needle cannula 20c.
[0059] While the present invention is satisfied by embodiments in
many different forms, there is shown in the drawings and described
herein in detail, the preferred embodiments of the invention, with
the understanding that the present disclosure is to be considered
as exemplary of the principles of the invention and is not intended
to limit the invention to the embodiments illustrated. Various
other embodiments will be apparent to and readily made by those
skilled in the art without departing from the scope and spirit of
the invention. The scope of the invention will be measured by the
appended claims and their equivalents.
* * * * *