U.S. patent number RE36,885 [Application Number 09/345,949] was granted by the patent office on 2000-09-26 for safety needle system assuring hazard-free handling after needle contamination.
This patent grant is currently assigned to MBO Laboratories, Inc.. Invention is credited to Jacob B. Blecher, William McCormick, Miles C. O'Donnell.
United States Patent |
RE36,885 |
Blecher , et al. |
September 26, 2000 |
Safety needle system assuring hazard-free handling after needle
contamination
Abstract
A safety needle and blood collection and sampling system
precluding needlstick injury by contaminated needles wherein a used
needle is captured immediately within its carrier upon retraction
of the needle flush with the carrier. Blood sampling is effected
without reverse flow through the system and without reuse or
exposure of a contaminated needle. Simplified means of assembling
the needle are also set forth to minimize cost with maximum
reliability notwithstanding withstanding a minimum of
components.
Inventors: |
Blecher; Jacob B. (Tampa,
FL), O'Donnell; Miles C. (Andover, MA), McCormick;
William (Carlisle, MA) |
Assignee: |
MBO Laboratories, Inc.
(Carlisle, MA)
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Family
ID: |
24445618 |
Appl.
No.: |
09/345,949 |
Filed: |
July 1, 1999 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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398772 |
Mar 6, 1995 |
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972013 |
Nov 6, 1992 |
5395347 |
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610583 |
Nov 8, 1990 |
5176655 |
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PCTUS9108063 |
Nov 6, 1991 |
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Reissue of: |
745803 |
Nov 8, 1996 |
05755699 |
May 26, 1998 |
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Current U.S.
Class: |
604/198; 604/110;
604/192 |
Current CPC
Class: |
A61M
5/3275 (20130101); A61M 25/0625 (20130101); A61M
25/0637 (20130101); A61M 2025/09116 (20130101); A61M
2005/325 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 5/32 (20060101); A61M
005/32 () |
Field of
Search: |
;604/110,162,167,187,192,195,197,198,203 ;600/578,579 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
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0281421 |
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Sep 1988 |
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EP |
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0314470 |
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Mar 1989 |
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EP |
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3808688 |
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Jan 1989 |
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DE |
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8807387 |
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Oct 1988 |
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WO |
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8904183 |
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May 1989 |
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WO |
|
8910767 |
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Nov 1989 |
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WO |
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9000075 |
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Jan 1990 |
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WO |
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Primary Examiner: Coggins; Wynn Wood
Assistant Examiner: Nguyen; A. T.
Attorney, Agent or Firm: Low and Low
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This is a continuation of Ser. No. 08/398,772 filed Mar. 6, 1995
now abandoned which is a continuation of application Ser. No.
07/972,013, filed Nov. 6, 1992, now U.S. Pat. No. 5,395,347 which
is a continuation-in-part of our application Ser. No. 07/610,583
filed Nov. 8, 1990, now U.S. Pat. No. 5,176,655 and is also a
continuation-in-part of our pending application PCT/US91/08063
filed Nov. 6, 1991 under the Patent Cooperation Treaty.
Claims
What we claim is:
1. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end,
a needle-carrying body having means for receiving the needle for
sliding movement therein and, said body having a front surface
having port means through which the needle distal portion is
initially extended for use outwardly of said front surface, and
retracted rearwardly after use in a direction through said port
means into said body with said needle pointed end no longer
extending through said body front surface, and,
movable safety means cooperatively associated with said needle and
fixedly mounted on said body against axial movement with respect
thereto and for blocking immediately and positively reemergence of
said needle distal portion through said body front surface upon
retraction of the pointed end of said needle in said rearward
direction through said port means to a position no longer extending
through said body front surface, thereby retaining said needle
pointed end within said body with no portion thereof extending or
projecting outwardly from said body through said front surface,
said safety means including
(1) imperforate blocking flange means disposed exteriorly of said
body adjacent said body front surface, and,
(2) spring means for bodily moving said flange means in a
needle-blocking direction transversely of said body into adjacent
and overlying relation to said port means on said body front
surface upon retraction of said needle into said body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed for hazard and injury after initial
retraction thereof into said body.
2. The safety needle system of claim 1 wherein said flange means is
in spring-urged lateral engagement with said needle distal portion
when said needle is in initial extended relation through said port
means.
3. The safety needle system of claim 1 further including means for
limiting bodily movement of said blocking flange means by said
spring means in said needle blocking direction to at all times
maintain said flange means in said adjacent and overlying blocking
relation to said port means on said body front surface when said
needle is retracted.
4. The safety needle system of claim 3 wherein said spring means is
disposed on one side of said body front surface, and wherein said
flange means has no portion thereof extending beyond said body
front surface on any other side thereof, thereby to preclude any
possible movement of said flange means in a direction unblocking
said port means against the force of said spring means.
5. The safety needle system of claim 4 wherein said blocking flange
means overlying said body front surface when the needle is
retracted terminates in an edge spaced inwardly from all sides of
said body front surface.
6. The safety needle system of claim 4 wherein said spring means is
disposed entirely exteriorly of said body in exposed, relation
thereby to facilitate assembly and inspection thereof to insure
proper operation.
7. The safety needle system of claim 4 wherein said spring means is
a leaf spring fixedly secured to said body and wherein said
blocking flange means thereof is a short, integral, and
substantially planar portion of said leaf spring.
8. The safety needle system of claim 7 wherein said blocking flange
means merges into an intermediate leaf spring portion disposed on
one side of said body, said intermediate spring portion being
disposed in spaced stressed relationship to said body when said
blocking flange means is in lateral engagement with said needle
initially extending through said port means.
9. The safety needle system of claim 8 wherein said leaf spring
includes gripping flange means latchingly engaged with said body to
securely mount said spring thereon.
10. The safety needle system of claim 9 wherein said gripping
flange means include spring legs extending along opposite sides of
said body, and said body has lug members respectively engaged with
said spring legs.
11. The safety needle system of claim 10 wherein said body lug
members include a pair of stop lugs adjacent said spring legs and
between said legs and said front surface, thereby to preclude any
forward movement of said legs and said leaf spring which would
cause said blocking flange to become spaced forwardly of said body
front surface.
12. A safety needle system comprising:
a needle having a proximal end and a distal portion terminating in
a pointed end,
a needle-carrying body having a bore for receiving the needle for
sliding movement therein and, said body having a front surface
having a port through which the needle distal portion is initially
extended for use outwardly of said front surface, and retracted
rearwardly after use in a direction through said port into said
body with said needle pointed end no longer extending through said
body front surface, and,
a movable safety flange cooperatively associated with said needle
and said body for blocking immediately and positively reemergence
of said needle distal portion through said body front surface upon
retraction of the pointed end of said needle in said rearward
direction through said port to a position no longer extending
through said body front surface, thereby retaining said needle
pointed end within said body with no portion thereof extending or
projecting outwardly from said body through said front surface,
said safety flange including
(1) an imperforate blocking portion disposed exteriorly of said
body adjacent said body front surface,
(2) a spring for bodily moving said blocking portion in a
needle-blocking direction transversely of said body and into
adjacent and overlying relation to said port on said body front
surface upon retraction of said needle into said body, and,
(3) a mount for said spring fixedly secured to said body to
preclude axial movement of said spring,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed for hazard and injury after initial
retraction thereof into said body.
13. A method of immediately and positively precluding needlestick
injury from a contaminated needle comprising the steps of:
providing an elongated needle having a pointed end,
providing a body slidably receiving the needle and having a front
surface through which the needle extends for use and is retracted
into the body after use,
providing a spring having an imperforate blocking flange portion,
and,
affixing said spring to the body so as to preclude axial movement
of said spring and to dispose the flange portion in adjacent
relation to the body front surface and in spring-urged relation
against the needle extending from the body when the needle is in
use,
whereby when the needle is retracted after use to bring its pointed
end flush with the body front surface, the imperforate blocking
flange is spring urged over the body front surface past the needle
point thereby to block any reemergence of the needle from the
body.
14. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end,
a needle-shielding body having means for receiving the needle for
sliding movement therein and, said body having a forward surface
having a port through which the needle distal portion is initially
extended for use outwardly of said forward surface, and retracted
rearwardly after use through said port into said body with said
needle pointed end no longer extending through said body forward
surface, and,
a movable safety device cooperatively associated with said needle
and fixedly mounted on said body against axial movement with
respect thereto and for blocking immediately and positively
substantial reemergence of said needle distal portion through said
body forward surface upon retraction of the pointed end of said
needle in said rearward direction toward and then past said safety
device and through said port to a position no longer extending
through said body forward surface, thereby retaining said needle
pointed end within said body with no portion thereof extending or
projecting outwardly from said body through said forward surface
and past said safety device,
said safety device including
(1) an imperforate blocking flange disposed exteriorly of said body
forward surface, and,
(2) a spring for bodily moving said flange in a needle-blocking
direction transversely of said body into adjacent and overlying
relation to said port on said body forward surface upon retraction
of said needle past and behind said flange and toward and into said
body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed through said port past said flange for
hazard and injury after initial retraction of said needle past said
flange and toward said body.
15. The safety needle system of claim 14 wherein said blocking
flange is spring urged to bear against the needle prior to
retraction of the needle.
16. The safety needle system of claim 15 wherein the needle pointed
end is transversely tapered to a distal point, and wherein said
blocking flange bears against said needle on the same side area
thereof as the needle distal point.
17. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end adjacent a bevelled end of the needle,
a needle-shielding body having means for receiving the needle for
sliding movement therein and, said body having a forward surface
having a port through which the needle distal portion is initially
extended for use outwardly of said forward surface, and retracted
rearwardly after use through said port into said body with said
needle pointed end no longer extending through said body forward
surface, and,
a movable safety device cooperatively associated with said needle
and fixedly mounted on said body against axial movement with
respect thereto and for blocking immediately and positively
substantial reemergence of said needle distal portion through said
body forward surface upon retraction of the pointed end of said
needle in said rearward direction toward and then past said safety
device and through said port to a position no longer extending
through said body forward surface, thereby retaining said needle
pointed end within said body with no portion thereof extending or
projecting outwardly from said body through said forward surface
and past said safety device,
said safety device including
(1) a blocking flange disposed exteriorly of said body forward
surface and having an edge thereof engaging said needle when said
needle extends forwardly from said body, and,
(2) a spring for bodily moving said flange in a needle-blocking
direction transversely of said body into adjacent and overlying
relation to said port on said body forward surface upon retraction
of said needle past and behind said flange and into said body,
wherein said flange has no portion thereof having an aperture or is
otherwise relieved such that any portion of the said needle would
be able to extend therethrough,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed through said port and past said flange
for hazard and injury after initial retraction of said needle
behind said flange and toward said body.
18. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end,
a needle-shielding body having a bore for receiving the needle for
sliding movement therein,
said body having a forward surface provided with a port through
which (a) the needle distal portion is initially extended for use
outwardly of said forward surface, and (b) the needle is retracted
rearwardly after use into said body with said needle pointed end no
longer extending substantially through said body .[.a movable
safety.]. .Iadd.forward surface in a position for use,
.Iaddend.and,
a movable safety member cooperatively associated with said needle
and said body for blocking immediately and positively reemergence
of said needle distal portion through said body forward surface
upon retraction of the pointed end of said needle in said rearward
direction past said safety member and toward said port, thereby
retaining said needle pointed end within said body with no portion
thereof extending or projecting outwardly for use from said body
through said forward surface thereof and past said safety
member,
said safety member including
(1) an imperforate blocking portion disposed exteriorly of said
body adjacent said body forward surface,
(2) a spring for bodily moving said blocking portion in a
needle-blocking direction transversely of said body and into
adjacent and overlying relation to said port on said body forward
surface upon retraction of said needle into said body, and,
(3) means for fixedly securing said safety member to said body to
preclude axial movement of said safety member on said body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed for hazard and injury after initial
retraction thereof past said safety member toward said body.
19. A method of immediately and positively precluding needlestick
injury from a contaminated needle comprising the steps of:
providing an elongated needle having a pointed end,
providing a body slidably receiving the needle and having a forward
surface through which the needle extends from the body for use and
is retracted toward and into the body after use,
providing a spring having an imperforate blocking flange, and,
affixing said spring to the body so as to preclude axial movement
of said spring with respect to the body and to dispose the flange
in adjacent relation to the body forward surface and in
spring-urged relation to bear against the needle extending from the
body when the needle is in use,
whereby when the needle is retracted after use to bring its pointed
end into immediate proximity to the body forward surface, the
imperforate blocking flange is spring urged over the body forward
surface past the needle pointed end thereby to block any
reemergence of the needle from the body and past the flange to
present a needlestick hazard.
20. The method of claim 19 including the further step of providing
the flange with peripheral dimensions relative to the body forward
surface such that after the flange is spring urged to blocking
position, no free edge of the flange is exposed laterally outwardly
of the body forward surface to preclude any lateral or rearward
movement of the flange by engagement with any free edge thereof.
.Iadd.
21. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end,
a needle-shielding body having a configuration for receiving the
needle for axial movement therein and,
said body having a forwardly-facing surface having a port through
which the needle distal portion is initially extended relative to
said body for use outwardly of said forwardly-facing surface, and
retracted relative to said body after use through said port into
said body with said needle pointed end no longer extending through
said body forwardly-facing surface, and,
a movable safety device cooperatively associated with said needle
and fixedly mounted on said body against axial movement with
respect thereto and for blocking immediately and positively
reemergence of said needle distal portion through said port at said
body forwardly-facing surface subsequent to relative retraction of
the pointed end of said needle toward and then past said safety
device and through said port to a position no longer extending
through said body forwardly-facing surface, thereby retaining said
needle pointed end within said body with no portion thereof
extending or projecting outwardly from said body through said port
and past said forwardly-facing surface and past said safety
device,
said safety device including
(1) an imperforate blocking flange disposed exteriorly of said body
forwardly-facing surface and,
(2) a spring for bodily moving said flange in a needle-blocking
direction transversely of said body into adjacent and overlying
relation to said port on said body forwardly-facing surface upon
relative movement of said needle distal portion and point past and
behind said flange and toward said body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed through said port past said flange for
hazard and injury after initial relative movement of said needle
past said flange and toward said body..Iaddend..Iadd.22. The safety
needle system of claim 21 wherein said blocking flange is spring
urged to bear against the needle prior to relative movement of the
needle toward said
body..Iaddend..Iadd. . The safety needle system of claim 22 wherein
the needle pointed end is transversely tapered to a distal point,
and wherein said blocking flange bears against said needle on the
same side area thereof as the needle distal
point..Iaddend..Iadd.24. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end adjacent a bevelled end of the needle,
a needle-shielding body having a configuration for receiving the
needle for axial movement therein and,
said body having a forwardly-facing surface having a port through
which the needle distal portion is initially extended relative to
said body for use outwardly of said forwardly-facing surface, and
retracted relative to said body after use through said port toward
said body with said needle pointed end no longer extending through
said body forwardly-facing surface, and,
a movable safety device cooperatively associated with said needle
and fixedly mounted on said body against axial movement with
respect thereto and for blocking immediately and positively
reemergence of said needle distal portion through and past said
safety device at said body forwardly-facing surface subsequent to
relative retraction of the pointed end of said needle with respect
to said body toward and then past said safety device and through
said port to a position no longer extending through said body
forwardly-facing surface, thereby retaining said needle pointed end
with no portion thereof extending or projecting outwardly from said
body through said forwardly-facing surface and past said safety
device,
said safety device including
(1) a blocking flange disposed exteriorly of said body
forwardly-facing surface and having an edge thereof engaging said
needle when said needle extends forwardly from said body, and
(2) a spring for bodily moving said flange in a needle-blocking
direction transversely of said body into adjacent and overlying
relation to said port on said body forwardly-facing surface upon
relative movement of said needle distal portion and point past and
behind said flange and toward said body, wherein said flange has no
portion thereof having an aperture or is otherwise relieved such
that any portion of the said needle would be able to extend
therethrough,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed through said port and past said flange
for hazard and injury after initial movement of said needle behind
said flange and toward
said body..Iaddend..Iadd.25. A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end, a needle-shielding body having a bore for
receiving the needle for axial movement therein,
said body having a forwardly-facing surface provided with a port
through which (a) the needle distal portion is initially extended
relative to said body for use outwardly of said forwardly-facing
surface, and (b) the needle is retracted relative to said body
after use into said body with said needle pointed end no longer
extending through said body forwardly-facing surface in a position
for use, and,
a movable safety member cooperatively associated with said needle
and said body for blocking immediately and positively reemergence
of said needle distal portion through said body forwardly-facing
surface and past said safety member subsequent to relative
retraction of the pointed end of said needle with respect to said
body past said safety member and toward said port, thereby
retaining said needle pointed end within said body with no portion
thereof extending or projecting outwardly for use from said body
through said forwardly-facing surface and also past said safety
member,
said safety member including
(1) an imperforate blocking portion disposed exteriorly of said
body adjacent said forwardly-facing surface,
(2) a spring for bodily moving said blocking portion in a
needle-blocking direction transversely of said body and into
adjacent and overlying relation to said port on said body
forwardly-facing surface upon relative movement of said needle
toward said body, and,
(3) a connection for fixedly securing said safety member to said
body to preclude axial movement of said safety member on said
body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed for hazard and injury after initial
movement thereof
past said safety member toward said body..Iaddend..Iadd.26. The
safety needle system of claim 21 wherein said blocking flange has
peripheral dimensions relative to the body forwardly-facing surface
such that after said flange is spring urged to blocking position,
no free edge of the flange is exposed laterally outwardly of the
body forwardly-facing surface, thereby to preclude any lateral or
rearward movement of the flange by engagement with any free edge
thereof..Iaddend..Iadd.27. A method of immediately and positively
precluding needlestick injury from a contaminated needle comprising
the steps of:
.Iadd.providing an elongated needle having a pointed end,
.Iadd.providing a body slidably receiving the needle and having a
forwardly-facing surface through which the needle extends from the
body for use and is relatively moved toward and into the body after
use,
providing a spring having an imperforate blocking flange, and
affixing said spring to the body so as to preclude axial movement
of said spring with respect to the body and to dispose the flange
in adjacent relation to the body forwardly-facing surface and in
spring urged relation to bear against the needle extending from the
body when the needle is in use,
whereby when the needle is relatively moved after use to bring its
pointed end into proximity to the body forward surface, the
imperforate flange is spring urged over the body forwardly-facing
surface past the needle pointed end thereby to block any
reemergence of the needle from the body and past the flange to
present a needlestick hazard..Iaddend..Iadd.28. The method of claim
27 including the further step of providing the flange with
peripheral dimensions relative to the body forwardly-facing surface
such that after the flange is spring urged to blocking position, no
free edge of the flange is exposed laterally outwardly of the body
forwardly-facing surface, thereby to preclude any lateral or
rearward movement of the
flange by engagement with any free edge thereof..Iaddend..Iadd.29.
A safety needle system comprising:
a needle having a proximal portion and a distal portion terminating
in a pointed end,
a needle-shielding body having a configuration for receiving the
needle for axial movement therein and,
said body having a portion including a forwardly-facing surface
having a port through which the needle distal portion is initially
extended relative to said body for use outwardly of said
forwardly-facing surface, and retracted relative to said body after
use through said port into said body with said needle pointed end
no longer extending through said body forwardly-facing surface,
and,
a movable safety device cooperatively associated with said needle
and fixedly mounted on said body portion against axial movement
with respect thereto and for blocking immediately and positively
reemergence of said needle distal portion through said port at said
body portion forwardly-facing surface subsequent to relative
retraction of the pointed end of said needle toward and then past
said safety device and through said port to a position no longer
extending through said body portion forwardly-facing surface,
thereby retaining said needle pointed end within said body with no
portion thereof extending or projecting outwardly from said body
portion through said port and past said forwardly-facing surface
and past said safety device,
said safety device including
(1) an imperforate blocking flange disposed exteriorly of said body
forwardly-facing surface, said flange having a terminal edge along
one peripheral side thereof engaging said needle when said needle
is in position for use, and,
(2) a spring for bodily moving said flange in a needle-blocking
direction transversely of said, body into adjacent and overlying
relation to said port on said body forwardly-facing surface upon
relative movement of said needle distal portion and point past and
behind said flange and toward said body,
whereby a used needle cannot have its pointed end or adjacent
distal portion re-exposed through said port past said flange for
hazard and injury after initial relative movement of said needle
past said flange and
toward said body..Iaddend..Iadd.30. The safety needle system of
claim 29 wherein said blocking flange terminal edge is spring urged
to bear against the needle prior to relative movement of the needle
toward said body..Iaddend..Iadd.31. The safety needle system of
claim 29 wherein the needle pointed end is transversely tapered to
a distal point, and wherein said blocking flange terminal edge
bears against said needle on the same side area thereof as the
needle distal point..Iaddend..Iadd.32. A safety needle system
comprising:
a needle having an axis, a proximal portion, and a distal portion
terminating in a pointed end,
a needle pointed end shielding body configured to receive the
needle and to enable relative axial slidable movement of said body
and said needle,
said needle and said body being movable relative to one another
between a first position and a second position, said needle and
said body in said first position thereof having said distal portion
of said needle and said pointed end thereof extending forwardly of
said body for use outwardly of said body and in said second
position thereof having said needle pointed
end in said body,
a movable safety device cooperatively associated with said needle
and mounted on said body for blocking emergence of said needle
pointed end forwardly of said body subsequent to relative movement
of said needle and said body into said second position,
said safety device including (1) an imperforate blocking flange
disposed forwardly of said needle pointed end when said needle and
said body lie in said second position, and (2) a spring for moving
said flange in a needle blocking direction transversely of said
body into a position blocking emergence of said needle pointed end
forwardly of said body..Iaddend..Iadd.33. A needle system according
to claim 32 wherein flange is positioned relative to said needle to
prevent relative movement of said needle and said body from said
second position into said first
position..Iaddend..Iadd.34. A needle system according to claim 32
wherein said body includes a bore for receiving said needle
generally coaxially within said bore, said flange intersecting the
axis of said needle and the axis of said bore upon movement thereof
into said needle pointed end blocking position..Iaddend..Iadd.35. A
needle system according to claim 32 including a base member for
fixedly mounting a proximal portion of said needle, said body and
said base member being spaced respective, axially discrete
distances from one another when said needle and said body lie in
said first and second positions thereof..Iaddend..Iadd.36. A needle
system according to claim 35 including a tether interconnecting
said body and said base member..Iaddend.
Description
BACKGROUND OF THE INVENTION
At high-volume medical facilities as blood bank centers. hospitals,
and the like, blood is drawn from human donors in large quantities
for processing and storage. In connection therewith, small volume
specimens of the blood are withdrawn from the blood collection
apparatus for necessary analysis. Blood withdrawal from humans
exposes the medical worker to the risk of accidental needlestick
injuries preparatory to connection of blood collection equipment to
the donor in the unavoidable handling of used, unshielded,
blood-contaminated needles.
In current practice, blood banking services, such as the American
Red Cross among others, obtain, process, and store whole blood and
blood components for a variety of medical uses such as transfusions
and the like. Before any such blood can be used, however, all
collected blood is analyzed to characterize its immune properties
or so-called "blood type". Equally or more importantly, all blood
must also be pre-tested for the presence of communicable disease
pathogens, such as the hepatitis virus and the human
immunodeficiency virus (HIV). As is well known, HIV is the
causative agent of the uniformly fatal AIDS disease in humans, and
thereby mandates the safest possible environment when handling
human blood.
Blood collection as now commonly practiced utilizes a system
including (1) a straight metal needle whose pointed end is inserted
into a human donor to access a blood vessel wherein the needle
usually includes a gripping portion bonded thereto to facilitate
manual manipulation; (2) a length of flexible tubing in fluid
communication at one end with the non-pointed proximal end of the
needle; and, (3) one or more blood storage bags connected to the
other end of the tubing. Additionally, helpful agents such as
citrate-phosphate dextrose (CPD) are commonly included as
anti-clotting additives within the collection system to prevent
coagulation of the blood and permit it to remain in fluid
condition.
Accordingly, traditional blood bag collection apparatus is thus a
closed, sterile system in which the blood flows from the donor's
blood vessel through the tubular metal needle, through the flexible
tubing and into the blood storage bag, and in the use thereof for
actual blood collection does not present a significant hazard to
medical personnel.
As indicated, however, it is necessary to take a small sample of
collected blood for analysis to insure the integrity and quality of
the bag quantity. Customarily, to obtain the test sample, the
medical or health care worker initially shuts off tubing flow as by
a clamp, and then grips the needle with one hand by the enlarged
grasping component thereof, removing the needle from the donor.
Thereafter, the exposed needle tip, which is now
blood-contaminated, is inserted through a rubber stopper or seal
into a sample collection test tube, and the clamp is released to
permit drawing of a sample of the collected blood reversely through
the needle and into the test tube usually held in the other
hand.
The open manipulation of the contaminated needle between withdrawal
and sample securement presents unwanted hazards to personnel in the
possibility of accidental needlestick injury.
Thus, the physical movement of the contaminated needle with one
hand toward and in close proximity to the other hand holding the
sample collector, there is a significant probability of
self-inflicted injury. In effecting the sampling, the needle point
may misalign with the rubber seal and puncture the worker's hand.
Additionally, upon withdrawal of the inserted needle from the
sample vial the frictional resistance of the rubber stopper
retarding needle withdrawal suddenly ceases as the needle pulls
dear, and there is an involuntary tendency and reflex for the
worker's hand holding the needle to recoil back toward the hand
holding the test tube.
The actual rates and likelihood of needlestick injuries with such
conventional blood collecting equipment have been well documented
in a report appearing in the publication TRANSFUSIONS. Vol. 29, No.
8, October, 1989, pages 693-695, entitled "Needlestick Injuries in
Blood Collection Staff--A Retrospective Analysis". Attempts to
improve the present practice by using a guard mechanism to reduce
the chances of accidentally puncturing the healthcare worker's
fingers, especially those grasping the sample tube, have reduced
but failed to eliminate the rates of such injuries. In one typical
Red Cross blood collection center, for example, there are about 10
to 12 needlestick injuries annually out of a total staff of 165
individuals who are in fact using such a prior art guard
device.
There is, therefore, a substantial and real need for means to
eliminate the needlestick hazard and its actual threat to the
health of medical workers in blood collection operations.
Concomitant to the foregoing, ease of fabrication, simplicity of
assembly, and reliability of function are prime requisites of
devices and equipment in the healthcare arts. To this end, the
present invention embraces improved and reliable needle-carrying
and manipulating elements, and modes of fabrication and assembly
thereof.
SUMMARY OF THE INVENTION
The present invention addresses this problem confronting the
healthcare industry and is designed specifically to eliminate
needlestick injuries of
the type described in connection with blood collection.
To this end, there is provided a new and improved system which (1)
shields the blood-contaminated needle simultaneously with its
withdrawal from the donor, and (2) uses a separate shielded needle
in a blood sample tube holder for the safe drawing of blood
samples, whereby the probability of an exposed contaminated point
being in any injury-causing proximity to a medical worker is
virtually nil, whereby the threat to or even the fear of HIV or
other disease by the worker is eliminated.
To this end, a unique and mechanically simple but reliable snap-on
needle enclosing guard is provided on a specialized needle device
disclosed herein, which is similar in some respects to the needle
safety device as set forth in our aforenoted application Ser. No.
07/610,583 now U.S. Pat. No. 5,176,655. Thereby, upon withdrawal of
the needle from the blood donor, the needle is immediately
retracted within the guard and a shield positively blocks the
contaminated needle point and access thereto. Two different forms
of the needle assembly are provided and which have differing
fabrication and use advantages.
Obviously, such protection precludes use of the same needle for the
aforementioned separate sampling purposes. The invention,
therefore, further embraces means to effect the necessary sampling
without the use of a contaminated needle and without concomitant
needlestick exposure of the worker.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be better understood in reference to the
accompanying drawings in which:
FIG. 1 is a diagrammatic illustration of prior art presently
practiced blood collection technique and equipment;
FIG. 2 is an illustration of prior art sample collection in a test
tube;
FIG. 3 is an overall perspective view of the blood collection
system of the invention;
FIG. 4 is similar to FIG. 3 showing the apparatus with advance of
the needle for insertion into the donor;
FIG. 5 is an illustration of the gripping means of the apparatus
for needle insertion;
FIG. 5A is a fragmentary side elevation of the device as seen in
FIG. 5;
FIG. 6A is an illustration of the system at commencement of needle
withdrawal from the donor;
FIG. 6B illustrates full withdrawal of the needle and enclosure
thereof with in the guard and protection of the needle point by the
shield;
FIG. 7 is a perspective view of the shield spring member;
FIG. 8A is a view of the end of the guard with the needle extended
therefrom but with the shield removed for clarity;
FIG. 8B is an enlarged side elevation similar to FIG. 8A but with
the shield in initial position;
FIG. 8C is a view taken on the line C--C of FIG. 8B;
FIG. 8D is a fragmentary view similar to FIG. 8B but with the
needle retracted and shielded;
FIG. 9A is a view similar to FIG. 8B illustrating a modified needle
carrier and guard;
FIG. 9B is a view taken on the line C--C of FIG. 9A;
FIG. 9C is a section view similar to FIG. 9B but with the shield
and needle removed;
FIG. 10A is a view similar to FIG. 6B but showing a modified form
of gripping portion for the needle.
FIG. 10B is a side view of the modified gripping member, internal
portions being shown in phantom;
FIG. 10C is a parital assembly view of a needle and its securing
disc with the modified gripping member;
FIG. 10D is an assembled view of the parts of FIG. 10C; and,
FIG. 10E are front and side views of the needle securing disc.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring to the drawings, there is generally indicated in FIGS. 1
and 2 a typical widely used blood collection and blood banking
system which in use presents the aforementioned safety and
needlestick hazards. Thus, a hollow metal cannula needle 10 having
a tapered point 12 has a finger-grippable enlarged annulus 14
secured to a proximal needle portion to facilitate handling and
maneuvering of the needle in the collection and sampling
process.
The donor's skin is punctured by the point 12 and the same is the
positioned in a blood vessel. The proximal end 16 of the needle is
bonded, clamped, or otherwise secured in known manner to flexible
tubing 18, the opposite end of which communicates with a blood
collection bag 20, whereby the needle, tubing, and bag form a
closed passageway for the flow of blood. Clamp means 22 of known
form is provided along tubing 18 to regulate or shut off blood flow
as may be required from time to time during collection or
thereafter.
There is also provided a standard blood specimen tube 24 having a
usual rubber seal stopper 26. Such sealed tubes are conventionally
provided on manufacture with a partial vacuum in its internal
chamber 28 to facilitate the drawing of blood thereinto. Such
specimen tubes 24 are routinely used for taking small volume blood
samples for analysis from donor blood obtained for blood bank
processing and storage purposes.
The current practice of obtaining the blood samples entails a
procedure which is in fact hazardous to health care workers. After
the desired quantity of blood is collected from the donor into bag
20, clamp 22 is used to shut off flow. The fingers 30 of one hand
of the worker grasp enlarged collar 14 and remove needle 10 from
the donor and move the now-contaminated needle point 12 through
space to aim and position the point 12 to puncture stopper seal 26
of the specimen tube 24, the latter being held by fingers 32 of the
other hand of the worker, as seen in FIG. 2. The clamp 22 is
released, and a small quantity of blood is drawn in reverse flow
from the tubing 18 into the partially evacuated chamber 28 in
specimen tube 24.
Apart from other real possibilities of mishandling the contaminated
needle tip 12 during donor withdrawal and holding the same openly
as the specimen tube is manually positioned, it is principally the
manipulation of needle 10 for alignment and entry into specimen
test tube 24 that constitutes a significant danger of accidental
needlestick injury to the health care worker. In necessarily moving
a blood-contaminated needle in one hand directly toward the other
hand holding the tube, and with sufficient moving force to
penetrate the stopper 26, the danger of self-inflicted injury
increases substantially. Thus, the needle point 12 may miss the
small-diameter stopper entirely and puncture the fingers 32.
Alternatively, the needle point may be improperly positioned at an
angle, on the stopper 26 and with stopper-puncturing force applied
the needle may slip laterally from the stopper and puncture the
worker's hand. These possibilities are entirely apart from other
imperfections of the worker as relatively poor eyesight,
nervousness, and the like.
Additionally, as earlier noted, there exists the threat of injury
in retracting the needle from the vial stopper 26 from a
recoil-like motion immediately after the needle 10 is pulled out of
stopper 26 and the previously existing frictional resistance of the
rubber to needle withdrawal suddenly ceases. As the
blood-contaminated needle then starts to "fly" 60 rearwardly on
leaving the stopper, there is a frequent immediate reflex by the
worker to stop the rearward motion and abruptly move the needle
again toward the fingers 32 holding the specimen tube with risk of
scratching these fingers with the needle.
The se difficulties are obviated by the apparatus and system of
FIGS. 3-9. Thus, therein, the blood-contaminated needle is shielded
simultaneously with its withdrawal from the donor whereby no
inadvertent puncture can occur, and a separate shielded needle in a
blood sample tube holder is used for safe drawing of the blood
sample.
One form of the invention is seen in FIG. 3 wherein needle cannula
40, somewhat similarly to needle 10 in FIG. 1, includes the usual
needle point 42 and further includes a special gripping portion or
base member 44 bonded therearound near the needle proximal end 46,
which latter is secured in usual manner to the flexible blood
collection tubing 48 having its internal flow passage 50. Tubing 48
terminates into one branch end 51 of a Y-connector 52 of well-known
form, while a length of tubing 54 extends from the other end 56 of
the Y-fitting 52 to communicate with blood bag 58. Well-known flow
control adjustable clamps 70, 70 are provided along the length of
tubing 48 and 54.
The Y-fitting includes a second branch 60 providing a sampling port
62 communicating with the tubing 48. The port 62 is a conventional
medical industry fitting, commonly known as a Luer female fitting.
The port 62 is adapted to cooperate with a standard blood
collection tube holder 64 having a standard multiple sample blood
collection needle 68 with a rubber sleeve 72 associated with a male
Luer fitting 74, which latter forms a dripless collection with
female port 62. Prior to sample collection into tube holder 64, the
fitting 74 is inserted into the port 62 to prevent drippage until
the collection tube is inserted into holder 64 in known manner to
open access to needle 68.
The safety and guard assembly 80 in FIGS. 3 and 4 carrying needle
40 in overall respects is in accordance with that disclosed and
claimed in U.S. Pat. No. 5,176,655. The same includes a needle
shielding or guide body 82 having an opening shown as a bore
extending from port means in its front surface or distal end 84 to
proximal end 86 within which needle 40 is slidably received. While
the body 82 is shown for illustrative purposes as being of square
or rectangular cross-section, the particular configuration may vary
within the limits of the required structure and function thereof.
Similarly, the assembly may readily be fabricated as by molding
from plastic, such as polyethylene, polyvinyl chloride, or the
like.
The rear portion of front guide 82 may be provided with laterally
extending flexible winglike members 88, and flexible restraints or
tethers 90 extending from wings 88 interconnect the guide 82 and
the base section 44 which is bonded to needle 40. In the absence of
wings 88, the tethers 90 may be connected directly to the body 82.
The wings 88 also include respective upstanding lugs 102, 102
outwardly from the guide body 82 for cooperation in use with an
upstanding lug 104 on base section 44, as described further
hereinafter.
Preferably, needle guide body 82 is provided on either side thereof
with a series of laterally extending projections or lug members 92
and 94 for cooperative abutment with gripping legs 96 of a
specially configured leaf spring 100. Obviously, the spring legs 96
could cooperate with other forms of abutments than flange-like
projections, as recesses in the guide body 82, for example.
The spring 100 forms an essential element of the safety needle
assembly. Thus, as shown in FIG. 3, the spring includes an inturned
imperforate blocking flange 98 at its forward end, which rests upon
and is biased transversely against needle 40 when the needle is
extended for use as shown. As seen in FIG. 3, the needle 40 is so
positioned relative to the imperforate flange 98 that the flange 98
bears against the needle on the side area thereof corresponding to
the maximum length of the needle at the pointed tip 42 of the
conventionally tapered or bevelled needle. The proximal end 101 of
spring 100 is also angled and stressed against the guide body 82,
the spring being maintained in position by the inwardly angled
portions 97 of legs 96 bearing against projections 94.
Uniquely, the one-piece spring 100 facilitates assembly of the
unit, as the gripping legs 97 thereof readily snap past the body
projections 94, and positively hold the spring on the body with no
chance or accidental removal. The assembly is thus a one-step
process minimizing cost with no sacrifice of safety or reliability.
As above noted, the projections 94 may be replaced by molded
indentations in the body 82 with equally effective results. The
forward or vertical projections 92 preclude any likelihood that the
spring could slide forwardly on the body to expose excessively the
needle, while the safety flange obviously precludes rearward
movement of the spring.
Accordingly, the needle assembly 80 comprises the needle 40, the
body 82 slidably crying the needle, the flexible tethers 90, the
rearmost base section 44 bonded to the needle, and the spring
100.
In use, and as set forth in applicants, U.S. Pat. No. 5,176,655,
during preparation for needle insertion through the skin of the
blood donor, the assembly 80 is as shown in FIG. 4 with the wings
88 initially flexed sufficiently downwardly to permit base section
44 to closely approach or abut the forward needle guide body 82
from the former position of FIG. 3. Thereupon, the wings 88 are
flexed upwardly and gripped as seen in FIG. 5. In so doing, the
wing lugs 102 are repositioned to be disposed immediately
rearwardly of the base member lug 104 as best seen in FIG. 5a.
Thereupon, with forward movement by the fingers gripping wings 88,
base member will move forwardly therewith to insert the needle
point into the donor.
While the foregoing is a positive and unitary handling of the
assembly 80 during needle insertion, under particular conditions
with a donor or patient, the medical technician may leave the wings
down and separately manipulate the base member 44 and the needle
carried thereby to insert the needle without concomitant
interlocked or interengaged lugs 102, 104.
As similarly taught in U.S. Pat. No. 5,176,655 safe needle
withdrawal from the donor's (or patient's) blood vessel is effected
by holding the needly shielding body 82 stationary adjacent the
needle skin entry point and with wings 88 relaxed to remove lugs
102 outwardly from behind lug 104. Thereupon, as shown in FIG. 6A,
the base section 44 (or the tubing 48 thereat) is pulled in a
proximal direction while needle guide body 82 is stationary thereby
causing needle 40 to slide rearwardly in the proximal direction
through the guideway therefor in body 82.
Thus, with the construction described, immediately as the
needlepoint 42 passes rearwardly of the distal end of spring 100,
the spring relaxes and snaps the angled face 98 thereof
transversely of the guide body forward face 84 and securely
encloses the needlepoint within guide body 82 as seen in FIG. 6D.
It should be borne in mind that as compared to the drawing
illustrations, the actual device of the invention is quite small
and the needlepoint is absolutely without capability of exposure
and contact with medical or donor personnel once retracted and
blocked, whereby needlestick injury is positively prevented in a
simple and effective manner.
More particularly, and this is an outstanding safety feature of the
invention, with the blocking flange face 98 immediately adjacent
the forward surface of the body at 84, as soon as the needle passes
behind the flange 98, the spring snaps the flange forward surface
over the 84 of the body into needle-blocking position and
positively precludes reemergence of the contaminated needle point
from the body 82 and thus needlestick injury is absolutely avoided.
While the needle may be withdrawn further into the body 82, such
extra movement is unnecessary as the safety spring acts on and over
the end face 84 of the body at the immediate point of potential
emergence of the contaminated needle. The fully withdrawn and
safety-shielded needle is shown in FIG. 6B, for example.
This contrasts with other attempts to reduce injury wherein the
needle must be withdrawn at least a minimum predetermined distance
beyond the exit from the tubular body. With such equipment, a
visual perusal indicates that the needle is not exposed, and
therefore may be considered to be safe. In fact, if the needle is
not retracted sufficiently inwardly from the exit aperture, it is
still able to be accidentally projected to cause hazard and is not
securely in a safe position immediately upon its retraction inside
the carrying body, with no further retraction being required Such
devices are known in the prior art.
A modified body 110 for receiving the needle is shown in FIGS. 9A-C
in lieu of the body 82. The same is not provided with a tubular
bore as in FIG. 3, but with an open-sided U- or V-configuration, as
well seen in FIG. 9B. In so doing, the spring 100 has a modified
rear tang 101a dimensioned to fit within the body 110 and bear
against the needle 40 therein. Along with the forward safety shield
98 of the spring, the needle is held firmly in the body, and upon
snap operation of shield 98 as heretofore, the needle is
made safe being blocked at its proximal end, gripped at 101a, and
overlaid by the body generally of the spring, whereby access cannot
be had to the needle point. In other respects the elements of the
assembly 80 are essentially the same. It will be evident that the
U-shaped body facilitates ready assembly of the needle system.
FIGS. 10A-10E illustrate a modified form of gripping member and a
simplified assembly technique for associating the needle 40
therewith. Thus, the modified gripping element 120 is similar to
that at 44 in FIG. 3 in being of polymeric material and generally
of cylindrical or polygonal external configuration and includes a
similar upstanding wing-engaging flange 104. Internally thereof,
however, instead of a simple through bore as in FIG. 3 for
receiving and bonding as by cement to the needle 40, only a short
needle-diameter bore portion 122 is provided in the distal end
thereof, the member 120 being countersunk therebehind to an
enlarged diameter chamber 124 having an internal front wall
126.
Cooperating therewith is needle-gripping and securing disc 128
having a diameter substantially that of chamber 124, and having a
hole or aperture 129 therethrough bounded by short radial cuts 130.
Hole 129 is of a diameter slightly less than that of the needle 40
whereby the cuts 130 permit slight flexing of the disc as the
needle is inserted therethrough in a snug mechanical interference
fit
Additionally, disc 128, which is preferably fabricated from thin
flexible metal, is provided at its periphery with a plurality of
rearwardly directed barbs or tangs 132. Accordingly, the disc is
assembled with gripping member 120 by axially advancing the disc
into chamber 124 against front wall 126, and is locked therein by
the presence of the barbs 132 whereby the disc cannot be removed
and the needle is securely positioned. Further, a liquid bonding
agent is applied about the needle at 134 (FIG. 10D) at its exit
from member 120, thereby sealing the needle to the base gripping
member 120.
In this manner the needle is reliably secured to the member 120
both by the mechanical-interaction of the disc 128 with base 120
and also by the bonding material 134.
Accordingly, in summary, it will be seen that in use with cannula
40 inserted into the patient, blood is collected into bag 58 as
desired, and then the clamp 70 is shut and the needle 68 opened
onto a collection tube for desired sampling without removal of the
needle 40 from the patient. As many samples may be taken as desired
with manipulation of the ramps 70, 70 prior to retraction and
immediate safetying of the needle 40 without reuse thereof or
hazard therefrom. The healthcare worker at no time has to
manipulate an unshielded blood-contaminated needle whether
collecting blood or taking samples for analysis.
The assembly of the present invention lends itself to ready
fabrication, as is evident from the foregoing. Thus, the body 82,
gripping portion 44, tethers 90 and wings 88 if used may be
simultaneously molded, as by injection molding, of polymeric
material, as polyvinyl chloride. The unit assembly may then have
the needle 40 appropriately positioned in the body 82 and the
gripping portion 44 for bonding of the distal needle portion to
member 44. If the modified U-body 110 of FIG. 9 is employed, the
needle need not necessarily be propositioned therein, but all
elements other than member 44 can be flexed to one side while the
needle is fixed to 44. In either case, thereafter the spring 100 is
snap-fitted onto the body, and the assembly is complete and ready
to use. The same advantages in assembly accrue with the needle
securement technique of FIGS. 10 A-D, as above discussed.
While we have disclosed our invention in preferred embodiments, it
is evident that the concepts and techniques thereof may be employed
in differing arrangements, such as indwelling needles, tubing,
biological fluid reservoir, drainage systems for pleural fluid
drainage, and the like, within the scope of the invention as
defined in the appended claims.
* * * * *