U.S. patent application number 10/173928 was filed with the patent office on 2003-11-06 for needle assembly.
This patent application is currently assigned to Becton, Dickinson and Company. Invention is credited to Crawford, Jamieson William Maclean.
Application Number | 20030208160 10/173928 |
Document ID | / |
Family ID | 29215910 |
Filed Date | 2003-11-06 |
United States Patent
Application |
20030208160 |
Kind Code |
A1 |
Crawford, Jamieson William
Maclean |
November 6, 2003 |
Needle assembly
Abstract
A non-patient safety needle assembly for mounting with a
conventional intravenous blood collection set is provided. The
non-patient needle assembly includes a hub assembly adapted for
mounting with a blood collection set, and an internal blunting
member including a blunted tip. The non-patient needle assembly
further includes an external cannula concentric with the internal
blunting member and including a non-patient puncture tip adjacent
the blunted tip. The external cannula is axially displaceable with
respect to the hub assembly between a first retracted position in
which the non-patient puncture tip extends beyond the blunted tip
and a second activated position in which blunted tip extends beyond
the non-patient puncture tip. A blood collection set including such
a non-patient needle assembly interconnected with an intravenous
needle assembly through tubing is also provided.
Inventors: |
Crawford, Jamieson William
Maclean; (New York, NY) |
Correspondence
Address: |
CASELLA & HESPOS LLP
274 MADISON AVENUE
SUITE 1703
NEW YORK
NY
10016-0701
US
|
Assignee: |
Becton, Dickinson and
Company
Franklin Lakes
NJ
|
Family ID: |
29215910 |
Appl. No.: |
10/173928 |
Filed: |
June 17, 2002 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
|
|
60377399 |
May 2, 2002 |
|
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|
Current U.S.
Class: |
604/164.08 ;
600/576; 604/263 |
Current CPC
Class: |
A61B 5/15074 20130101;
A61B 5/150809 20130101; A61B 5/150641 20130101; A61M 2005/3212
20130101; A61B 5/150389 20130101; A61B 5/150816 20130101; A61B
5/15003 20130101; A61B 5/150717 20130101; A61B 5/154 20130101; A61B
5/150519 20130101; A61B 5/150572 20130101; A61B 5/150732 20130101;
A61B 5/150916 20130101 |
Class at
Publication: |
604/164.08 ;
600/576; 604/263 |
International
Class: |
A61M 005/178 |
Claims
What is claimed:
1. A non-patient safety needle assembly for mounting with a
conventional intravenous blood collection set comprising: a hub
assembly having opposing first and second ends, said first end
adapted for mounting with a blood collection set; an internal
blunting member in fixed engagement with said hub assembly, said
internal blunting member having a first end concentric with said
hub assembly, a second end having a blunted tip and an internal
lumen extending through said internal blunting member from said
first end to said blunted tip; and an external cannula concentric
with said internal blunting member and axially displaceable with
respect to said hub assembly, said external cannula including a
non-patient puncture tip adjacent said blunted tip of said internal
blunting member, said external cannula adapted for axial
displacement with respect to said hub assembly between a first
retracted position in which said non-patient puncture tip extends
beyond said blunted tip of said internal blunting member and a
second activated position in which said blunted tip of said
internal blunting member extends beyond said non-patient puncture
tip of said external cannula.
2. A safety needle assembly as in claim 1, further comprising a
carriage assembly integral with said external cannula and
concentric with said internal blunting member, said carriage
assembly provided for slidable engagement with said hub
assembly.
3. A safety needle assembly as in claim 1, further comprising a
sleeve extending about said non-patient puncture tip.
4. A safety needle assembly as in claim 1, further comprising a
fitting for engagement with a blood collection set.
5. A safety needle assembly as in claim 4, wherein said fitting
comprises a luer fitting.
6. A safety needle assembly as in claim 1, further comprising means
for attaching said needle assembly to a holder capable of holding
blood collection tubes.
7. A safety needle assembly as in claim 6, wherein said attaching
means comprises threads extending circumferentially about said hub
assembly.
8. A safety needle assembly as in claim 1, wherein said external
cannula is axially displaceable between said first retracted
position and said second activated position in a single axial
direction.
9. A safety needle assembly as in claim 8, further comprising a
locking mechanism for preventing axial displacement of said
external cannula from said second activated position to said first
retracted position.
10. A blood collection set comprising: a) in intravenous needle
assembly including a needle having an intravenous puncture tip; b)
a tubing in fluid communication with said intravenous needle
assembly; and c) a non-patient needle assembly in fluid
communication with said tubing, said non-patient needle assembly
comprising: i) a hub assembly having opposing first and second
ends, said first end in engagement with said tubing, ii) an
internal blunting member in fixed engagement with said hub
assembly, said internal blunting member having a first end
concentric with said hub assembly, a second end having a blunted
tip and an internal lumen extending through said internal blunting
member from said first end to said blunted tip, and iii) an
external cannula concentric with said internal blunting member and
axially displaceable with respect to said hub assembly, said
external cannula including a non-patient puncture tip adjacent said
blunted tip of said internal blunting member, said external cannula
adapted for axial displacement with respect to said hub assembly
between a first retracted position in which said non-patient
puncture tip extends beyond said blunted tip of said internal
blunting member and a second activated position in which said
blunted tip of said internal blunting member extends beyond said
non-patient puncture tip of said external cannula.
11. A blood collection set as in claim 10, further comprising a
carriage assembly integral with said external cannula and
concentric with said internal blunting member, said carriage
assembly provided for slidable engagement with said hub
assembly.
12. A blood collection set as in claim 10, further comprising a
sleeve extending about said non-patient puncture tip.
13. A blood collection set as in claim 10, wherein said hub
assembly is removably attached to said tubing.
14. A blood collection set as in claim 13, further comprising a
luer fitting between said tubing and said hub assembly.
15. A blood collection set as in claim 10, wherein said non-patient
needle assembly further comprises means for attaching said blood
collection set to a holder capable of holding blood collection
tubes.
16. A blood collection set as in claim 15, wherein said attaching
means comprises threads extending circumferentially about said hub
assembly.
17. A blood collection set as in claim 10, wherein said external
cannula is axially displaceable between said first retracted
position and said second activated position in a single axial
direction.
18. A blood collection set as in claim 17, further comprising a
locking mechanism for preventing axial displacement of said
external cannula from said second activated position to said first
retracted position.
19. A blood collection set comprising: a) in intravenous needle
assembly including a needle having an intravenous puncture tip; b)
a tubing in fluid communication with said intravenous needle
assembly; and c) a non-patient needle assembly in fluid
communication with said tubing, said non-patient needle assembly
comprising: i) a hub assembly having a first end, an opposing
second end, and a central opening extending through said hub
assembly from said first end to said second end, said first end in
engagement with said tubing, ii) an internal blunting member having
a first end, an opposing second end, and an internal lumen
extending through said internal blunting member from said first end
to said second end, said first end positioned concentrically within
said central opening of said hub assembly, said second end having a
blunted tip, iii) a carriage assembly having a first end and an
opposed second end, said first end of said carriage assembly
extending through said second end of said hub assembly into said
central opening of said hub assembly and in sliding engagement with
said hub assembly, and iv) an external cannula extending from said
second end of said carriage assembly and concentric with said
internal blunting member, said external cannula including a
non-patient puncture tip adjacent said blunted tip of said internal
blunting member, wherein sliding of said carriage assembly within
said hub assembly causes axial movement of said external cannula
about said internal blunting member between a first retracted
position in which said non-patient puncture tip extends beyond said
blunted tip of said internal blunting member and a second activated
position in which said blunted tip of said internal blunting member
extends beyond said non-patient puncture tip of said external
cannula.
Description
RELATED APPLICATION
[0001] This application is a non-provisional of Appl. No.
60/377,399 filed on May 2, 2002.
BACKGROUND OF THE INVENTION
[0002] 1. Field of the Invention
[0003] The present invention relates to needle assemblies having a
blunting element for safe and convenient handling. More
particularly, the present invention relates to a non-patient needle
assembly which includes a blunting element for the non-patient
needle for use in connection with a blood collection set.
[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 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. Consequently, existing blood
collection systems, for example, 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.
[0006] Conventional intravenous tubing sets are commonly employed
for use in connection with blood collection. A particularly useful
intravenous tubing set for such application is the VACUTAINER.RTM.
Brand Safety-Lok.TM. Blood Collection Set, available from Becton
Dickinson and Company of Franklin Lakes, N.J. Such a Blood
Collection Set includes an intravenous needle assembly attached to
one end of a tube, with the other end of the tube connected to a
blood collection needle assembly including a stopper puncture
needle, or a "non-patient" puncture needle. In use, the intravenous
needle assembly is inserted into the vein of a patient, and a tube
holder is attached to the blood collection needle assembly. An
evacuated tube is inserted into the tube holder, and the stopper
puncture needle or non-patient puncture needle punctures the
stopper of the tube, allowing blood to flow into the tube.
[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. Many arrangements
have been designed for protecting used needle tips. For example,
U.S. Pat. No. 5,120,320 to Fayngold and U.S. Pat. No. 5,192,275 to
Burns disclose safety shields for use in connection with the
intravenous needle assembly of such blood collection assemblies.
The safety shield covers and protects the intravenous needle
assembly after use. Also, PCT International Publication No. WO
98/42393 discloses a parenteral fluid transfer apparatus useful as
a blood collection assembly, which includes an intravenous needle
assembly having a rod or probe-like blunting member which is
extendable beyond the tip of the intravenous needle tip to prevent
accidental needle-stick wounds from occurring after use of the
device. Such a device, however, does not provide protection for the
second end of the needle at the non-patient end of the
assembly.
[0008] Accordingly, a need exists for a blood collection set with a
non-patient needle assembly which provides for safety blunting of
the non-patient needle tip and which is simple to manufacture and
easy to operate.
SUMMARY OF THE INVENTION
[0009] The present invention is directed to a non-patient safety
needle assembly for mounting with a conventional intravenous blood
collection set. The non-patient needle assembly includes a hub
assembly having opposing first and second ends, with the first end
being adapted for mounting with a blood collection set. An internal
blunting member is in fixed engagement with the hub assembly. The
internal blunting member includes a first end which is concentric
with the hub assembly, a second end having a blunted tip, and an
internal lumen which extends through the internal blunting member
from the first end to the blunted tip. The needle assembly also
includes an external cannula concentric with the internal blunting
member and axially displaceable with respect to the hub assembly.
The external cannula includes a non-patient puncture tip at one end
thereof adjacent the blunted tip of the internal blunting member.
The external cannula is adapted for axial displacement with respect
to the hub assembly between a first retracted position, in which
the non-patient puncture tip extends beyond the blunted tip, and a
second activated position in which the blunted tip extends beyond
the non-patient puncture tip.
[0010] The non-patient needle assembly preferably includes a
carriage assembly which is integral with the external cannula and
concentric with the internal blunting member, and which is in
slidable engagement with the hub assembly. Also, a sleeve
preferably extends about the non-patient puncture tip.
[0011] The needle assembly also includes a fitting, such as a luer
fitting, for engagement with a blood collection set. Additionally,
the needle assembly includes means for attaching the needle
assembly to a holder capable of holding blood collection tubes,
such as threads extending circumferentially about the hub
assembly.
[0012] Preferably, the external cannula is axially displaceable
between the first retracted position and the second activated
position in a single axial direction. The needle assembly may also
include a locking mechanism for preventing axial displacement of
the external cannula from the second activated position to the
first retracted position.
[0013] The present invention is also directed to a blood collection
set which includes such a non-patient needle assembly in fluid
communication with a tubing, which tubing is in fluid communication
with an intravenous needle assembly including a needle having an
intravenous puncture tip. Preferably, the non-patient needle
assembly includes a hub assembly which is removably attached to the
tubing, such as through a luer fitting.
DESCRIPTION OF THE DRAWINGS
[0014] FIG. 1 is a perspective view of a blood collection set in
accordance with the present invention, including a non-patient
safety needle assembly attached to an intravenous needle assembly
through tubing.
[0015] FIG. 2 is a perspective view of a non-patient safety needle
assembly in accordance with the present invention shown in a
retracted position.
[0016] FIG. 3 is a side cross-sectional view of the non-patient
safety needle assembly of FIG. 2 shown in a retracted position.
[0017] FIG. 4 is a perspective view of the non-patient safety
needle assembly of FIG. 2 shown in an activated blunted
position.
[0018] FIG. 5 is a side cross-sectional view of the non-patient
safety needle assembly of FIG. 4 in an activated blunted
position.
DETAILED DESCRIPTION
[0019] While the present invention is satisfied by embodiments in
many different forms, there is shown in the drawings and will
herein be described in detail, the preferred embodiments of the
invention, with the understanding that the present disclosure is to
be considered as examplary 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.
[0020] Referring to the drawings in which like reference characters
refer to like parts throughout the several views thereof, FIG. 1
illustrates a blood collection set in accordance with the present
invention and the related features. The present invention is
generally described in terms of a blood collection set, and
encompasses such a blood collection set as well as a non-patient
safety needle assembly for use in such a blood collection set.
[0021] Blood collection set 10 is depicted generally including
non-patient needle assembly 12 in engagement with a conventional
intravenous blood collection assembly. Non-patient needle assembly
12 and the intravenous blood collection assembly include
interrelating elements to provide for engagement therebetween. In
particular, non-patient needle assembly 12 is interconnected with
intravenous needle assembly 90 through tubing 84. Such
interconnection may be provided through any method as is known in
the art, such as through a luer fitting.
[0022] Intravenous needle assembly 90 includes an intravenous
cannula 92 having an intravenous puncture tip 94, for insertion
into the vein of a patient, for example, during a blood collection
procedure. Intravenous needle assembly 90 further includes a
butterfly-type wing assembly 96, for use in connection with
positioning and placement of intravenous needle assembly 90 during
a blood collection procedure, as is known in the art.
[0023] As noted, intravenous needle assembly 90 is interconnected
through tubing 84 to non-patient needle assembly 12. In addition,
non-patient needle assembly 12 may be provided with means for
attachment to a separate holder (not shown) for use in connection
with blood collection tubes, such as a snap fit attachment, or,
more desirably, attachment threads 14 which engage a threaded
section of the holder.
[0024] Non-patient needle assembly 12 of the present invention is
shown more particularly at FIGS. 2-5. Non-patient needle assembly
12 includes hub assembly 20 having first end 22 and second end 24,
with an internal opening 26 extending therethrough from first end
22 to second end 24. First end 22 of hub assembly 20 is adapted for
mounting with tubing 84 of blood collection set 10. For example,
hub assembly 20 may further include ferrule 30 extending from first
end 22. Ferrule 30 may be integrally formed with hub assembly 20,
or may be a separate member attached to hub assembly 20. Desirably,
hub assembly 20 includes shoulder 34 at an internal opening within
first end 22 for engagement with ferrule 30 such that ferrule 30
interfits within first end 22 and rests against shoulder 34 of hub
assembly 20. Ferrule 30 includes an internal opening 36 extending
therethrough, which is in fluid communication with internal opening
26 of hub assembly 20.
[0025] Non-patient needle assembly 12 further includes internal
blunting member 40 in fixed engagement with hub assembly 20.
Internal blunting member 40 is a generally tubular hollow structure
which includes first end 42 and second end 44 with a central bore
or internal lumen 48 extending through the length thereof. Internal
lumen 48 allows fluid flow through needle assembly 12 during use.
Second end 44 is blunted to form blunt tip 46 as an end portion,
such that, under ordinary hand pressure, blunt tip 46 will not
easily puncture human skin or other biological tissue.
[0026] Internal blunting member 40 is provided in concentric
relation with hub assembly 20. More particularly, first end 42 of
internal blunting member 40 is positioned concentrically within
internal opening 26 of hub assembly 20, while second end 44 of
internal blunting member 40 extends axially from second end 22 of
hub assembly 20. Internal lumen 48 is in fluid communication with
internal opening 26 of hub assembly 20 and, in turn, internal
opening 36 of ferrule 30. Internal blunting member 40 may be
integrally formed with hub assembly 20, but is more desirably a
separate member which is fixedly attached to hub assembly 20. In
particular, as depicted in FIG. 3, first end 42 of internal
blunting member 40 is provided within internal opening 26 of hub
assembly 20 and abuts lip 38 of ferrule 30, which extends within
first end 22 of hub assembly 20. In this manner, hub assembly 20,
ferrule 30 and internal blunting member 40 form a single unitary
structure.
[0027] Non-patient needle assembly 12 further includes external
cannula 50 extending concentrically about internal blunting member
40. External cannula 50 is adapted for axial movement with respect
to hub assembly 20, as will be described in more detail herein.
External cannula 50 includes a first end 52 and a second end 54,
with a central bore or internal lumen 58 extending through the
length thereof. Second end 54 includes non-patient puncture tip 56,
which is provided in the form of a needle tip for puncturing a
stopper such as is used in an evacuated tube, for example, during a
blood collection procedure. External cannula 50 is further provided
with an elastomeric sleeve 80 extending about second end 44 and
covering non-patient puncture tip 56, as is generally known in the
art.
[0028] As best depicted in FIGS. 2 and 3, second end 54 of external
cannula 50 is adjacent second end 44 of internal blunting member
40. External cannula 50 is axially slidable along second end 44 of
internal blunting member 40 within the internal lumen 58 of
external cannula 50. As such, external cannula 50 is axially
displaceable with respect to hub assembly 20, since internal
blunting member 40 is in fixed engagement with hub assembly 20. The
inner diameter of external cannula 50 is substantially the same as
the outer diameter of second end 44 of internal blunting member 40.
As such, external cannula 50 and internal blunting member 40 are
dimensioned and configured for a close fit so that blunt tip 46 of
internal blunting member 40 lies flat against the internal surface
of second end 54 of external cannula 50 within internal lumen 58
when non-patient needle assembly 12 is in a retracted position, as
shown in FIGS. 2 and 3, and so that non-patient puncture tip 56
lies flat against the external surface of second end 44 of internal
blunting member 40 when non-patient needle assembly 12 is in an
activated position, as shown in FIGS. 4 and 5.
[0029] It may be desirable to lubricate the mating surfaces of
external cannula 50 and internal blunting member 40, as well as to
provide a seal between them to prevent the unwanted flow of air
bubbles. Accordingly, a drop of viscous sealant-lubricant, such as
petroleum jelly, may be provided about the mating surfaces
thereof.
[0030] As noted, external cannula 50 is adapted for axial movement
with respect to hub assembly 20. For example, external cannula 50
may be axially slidable within internal opening 26 of hub assembly
20 between a first retracted position in which non-patient puncture
tip 56 extends beyond blunt tip 46, and a second activated position
in which blunt tip 46 extends beyond non-patient puncture tip 56.
More particularly, axial movement of external cannula 50 within
internal opening 26 of hub assembly 20 in a direction of arrow 100
causes external cannula 50 to axially displace with respect to hub
assembly 20. Since internal blunting member 40 is fixedly attached
to hub assembly 20, such axial displacement causes external cannula
50 to axially slide along second end 44 of internal blunting member
40. Since second end 54 of external cannula 50 is adjacent second
end 44 of internal blunting member 40 and non-patient puncture tip
56 extends beyond blunt tip 46, such axial movement causes second
end 54 of external cannula 50 to axially displace with respect to
second end 44 of internal blunting member 40, which causes
non-patient puncture tip 56 to slide about internal blunting member
40 such that blunt tip 46 extends beyond non-patient puncture tip
56, as depicted in FIGS. 4 and 5. As such, non-patient puncture tip
56 is blunted.
[0031] Slidable engagement of external cannula 50 and hub assembly
20 may be effected through carriage assembly 60. Carriage assembly
60 is concentric with external cannula 50, and is provided for
slidable engagement within internal opening 26 of hub assembly 20.
Carriage assembly 60 may be integral with external cannula 50, or
may be a separate member which is fixedly adhered to external
cannula 50 such as through the use of an adhesive. Carriage
assembly 60 is defined by a generally tubular body, although other
shapes or configurations may be apparent to those skilled in the
art.
[0032] Carriage assembly 60 includes a central nub portion 62, a
forward portion 64 and a rear portion 66. As shown in FIGS. 2 and
3, forward portion 64 of carriage assembly 60 is positioned within
internal opening 26 of hub assembly 20 when non-patient needle
assembly 12 is assembled and in the retracted position. Forward
portion 64 of carriage assembly 60 includes a surface 70 for
interference engagement with shoulder 28 of hub assembly 20. Such
interference engagement prevents carriage assembly 60, and
therefore external cannula 50 which is attached thereto, from being
easily removed or disassembled from hub assembly 20 after assembly
thereof.
[0033] Central nub portion 62 includes a tapered surface 68
extending circumferentially thereabout. Tapered surface 68 provides
an interference engagement with face 32 at second end 24 of hub
assembly 20, preventing axial displacement of carriage assembly 60
with respect to hub assembly 20 without a force exerted thereon, as
will be described in more detail herein.
[0034] Carriage assembly 60 further includes rear face 72 which is
adapted for engagement with the top surface of a blood collection
tube during use. As will be discussed with respect to the use and
operation of non-patient needle assembly 12, rear face 72 provides
a mechanism for activating non-patient needle assembly 12, thereby
axially displacing external cannula 50 with respect to hub assembly
20 between a first retracted position and a second activated
position.
[0035] External cannula 50 and hub assembly 20 may be reversibly
axially displaceable with respect to each other, such that external
cannula 50 may displace with respect to hub assembly 20 from either
the first retracted position to the second activated position or
from the second activated position to the first retracted position.
In preferred embodiments, external cannula 50 is axially
displaceable with respect to hub assembly 20 in only a single
direction from the first retracted position to the second activated
position. As such, non-patient needle assembly 12 may be provided
with means for preventing axial displacement of external cannula 50
from the second activated position to the first retracted position
once it has been activated, such as a locking mechanism. For
example, central nub portion 62 may further include a surface 76
which extends circumferentially about central nub portion 62 for
interference engagement with shoulder 28 of hub assembly 20 after
activation of non-patient needle assembly 12 from the first
retracted position to the second activated position. Such
interference engagement prevents axial movement of carriage
assembly 60 with respect to hub assembly 20 in a direction opposite
arrow 100 after movement from the first retracted position to the
second activated position.
[0036] Non-patient needle assembly 12 may be provided with means
for indicating movement of external cannula 50 with respect to hub
assembly 20 between the first retracted position and the second
activated position. Such means may be a visible, audible and/or
tactile indicator, identifying movement between the first retracted
position and the second extended position. For example, in one
particular embodiment, a tactile indication is accomplished through
the interference engagement of tapered surface 68 with face 32 of
hub assembly 20, as well as the interference engagement of front
face 74 of carriage assembly 60 with face 32 of hub assembly 20.
For example, when carriage assembly 60 is axially displaced in a
direction of arrow 100, the user will detect an audible and/or
tactile detection through the forcing of tapered surface 68 of
carriage assembly 60 past face 32 of hub assembly 20. When carriage
assembly 60 is completely displaced to the second activated
position, a further audible and/or tactile detection will be
detected by front face 74 of carriage assembly 60 abutting with
face 32 of hub assembly 20.
[0037] Non-patient needle assembly 12 may be provided with a needle
cover (not shown) for covering non-patient puncture tip 56 of
external cannula 50 prior to assembling of non-patient needle
assembly 12 with a needle holder. Such a needle cover may be
constructed of rigid polymeric material. This needle cover may be
attached to non-patient needle holder 12, for example, by threaded
engagement with external threads 14 extending about hub assembly
20. In this manner, this needle cover can be removed from
non-patient needle assembly 12 prior to assembly with a needle
holder by unthreading the needle cover from external threads 14,
and then threading external threads 14 into an internal thread of
such a needle holder, as is known in the art.
[0038] Operation and use of the blood collection set including the
non-patient needle assembly will now be described with reference to
FIGS. 1-5. In use, blood collection set 10 is provided including
intravenous needle assembly 90 and non-patient needle assembly 12
attached through tubing 84. Alternatively, non-patient needle
assembly 12 may be provided as separate from a blood collection
assembly including intravenous needle assembly 90 and tubing 84
interconnected. In such a case, non-patient needle assembly 12 is
first attached to tubing 84, for example through connector 86 which
is desirably a luer fitting for connection with ferrule 30.
[0039] Non-patient needle assembly 12 is provided including a
needle cover (not shown) extending over external cannula 50. When
preparing the blood collection set for use in a sampling procedure,
the needle cover is removed from external cannula 50, and
non-patient needle assembly 12 is then attached to a needle holder,
such as by threading external threads 14 with internal threads
provided on a standard needle holder.
[0040] Moreover, a further needle cover (not shown) may extend over
intravenous cannula 92 encompassing intravenous puncture tip 94.
This needle cover is also removed. Venipuncture is then conducted
in known manner, whereby intravenous puncture tip 94 is inserted
into a vein of a patient, and an evacuated tube having a pierceable
closure is inserted into the needle holder, such that the
pierceable closure of the evacuated tube contacts sleeve 80
extending about external cannula 50. When slight pressure is
exerted on the evacuated tube, the piercable closure contacting
sleeve 80 causes sleeve 80 to displace, thereby causing non-patient
puncture tip 56 to puncture sleeve 80 and, in turn, the piercable
closure of the evacuated tube. At such time, the interior of the
evacuated tube and internal lumen 58 of external cannula 50 are in
fluid communication. Since the interior of the evacuated tube is at
a negative pressure, blood is drawn from the vein of the patient,
through intravenous needle assembly 90, through tubing 84 and
connector 86, through internal opening 36 of ferrule 30, through
internal lumen 48 of internal blunting member 40, through internal
lumen 58 of external cannula 50, and into the evacuated tube.
[0041] When all desired samples have been drawn, activation of the
non-patient needle assembly is accomplished. Activation of the
non-patient needle assembly is desirably accomplished while
venipuncture is maintained, that is while intravenous puncture tip
94 of intravenous needle assembly 90 is maintained within the vein
of the patient. It is noted that intravenous needle assembly 90 may
include a blunting member for blunting of the intravenous needle,
which blunting operation is separate from blunting of the
non-patient needle.
[0042] Blunting of the non-patient needle assembly 12 is
accomplished by exerting pressure in a direction of arrow 100 on
rear face 72 of carriage assembly 60. In particular, during
sampling, the top surface of the pierceable closure of the
evacuated tube contacts rear face 72 of carriage assembly 60 within
the holder. When additional force is exerted against the evacuated
tube in a direction of arrow 100, rear face 72 is forced in the
direction of arrow 100. Such force causes interference engagement
between tapered surface 68 of central nub portion 62 of carriage
assembly 60 against face 32 of hub assembly 20. As such, central
nub portion 62 of carriage 60 is forced within internal opening 26
of hub assembly 20 due to the configuration of tapered surface 82,
thereby causing axial movement of carriage assembly 60 with respect
to hub assembly 20.
[0043] Since carriage assembly 60 is attached to external cannula
50, axial displacement of carriage assembly 60 with respect to hub
assembly 20 causes axial displacement of external cannula 50 with
respect to hub assembly 20. Moreover, since internal blunting
member 40 is attached to hub assembly 20, axial displacement of
external cannula 50 with respect to hub assembly 20 causes second
end 54 of external cannula 50 to axially displace with respect to
second end 44 of internal blunting member 40. Since blunted tip 44
is positioned short of non-patient puncture tip 56 such that
non-patient puncture tip 56 extends beyond blunted tip 44, axial
displacement of second end 54 of external cannula 50 with respect
to second end 44 of internal blunting member 40 causes relative
axial displacement of non-patient puncture tip 56 with respect to
blunted tip 46. More particularly, when external cannula 50 is
axially displaced in the direction of arrow 100, non-patient
puncture tip 56 slides about internal blunting member 40 such that
blunted tip 46 is exposed and extends beyond non-patient puncture
tip 56, as depicted in FIGS. 4 and 5. As such, non-patient puncture
tip 56 is effectively blunted. Non-patient needle assembly 12 can
then be appropriately discarded.
[0044] As noted, the needle assembly of the present invention may
be used in conjunction with a standard needle holder known for use
in blood collection. It is also contemplated that the needle
assembly of the present invention may be used with a needle holder
which includes a mechanism for causing axial displacement of
carriage assembly 60 with respect to hub assembly 20 to effect
blunting of non-patient puncture tip 56. For example, as opposed to
exerting pressure on an evacuated tube extending within the needle
holder, a mechanism on or within the needle holder may be activated
which causes carriage assembly 60 to axially displace.
[0045] The needle assembly of the present invention may be
comprised of moldable e parts which can be mass produced from a
variety of materials including, for example, polyethylene,
polyvinyl chloride, polystyrene or the like. Materials will be
selected which will provide the proper support for the structure of
the invention in its use, but which will also provide a degree of
resiliency for the purpose or providing the cooperative relative
movement.
[0046] While the needle assembly of the present invention has been
described in terms of one 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, as which
are well known in the art for use with conventional needle
assemblies.
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