Note : Les descriptions sont présentées dans la langue officielle dans laquelle elles ont été soumises.
CA 02536880 2006-02-17
TITLE OF THE INVENTION 1
Catheter Safety Needle
FIELD OF THE INVENTION
The present invention relates to a catheter insertion needle that is
retractable into
a safety position after use to prevent accidental sticks.
BACKGROUND OF THE INVENTION
The introduction of a device through tissue of a living body typically
requires the
use of a sharp instrument such as a scalpel or a needle to provide access into
the tissue.
For example, for the insertion of a catheter into a blood vessel, a needle is
used to access
the vessel. The needle includes a hollow bore cannula that provides a conduit
for an
introducer device, such as a guide wire, to be inserted through the cannula
and into the
blood vessel. After insertion of the guide wire, the needle is withdrawn
proximally along
the guide wire and discarded. The catheter is then inserted into the vessel
over the guide
wire, and the guide wire is then removed.
The removal of the needle exposes the sharp insertion tip of the needle to the
medical personnel inserting the catheter. This sharp tip poses a danger of a
needle stick
to the medical personnel. Additionally, this tip is contaminated with the
patient's blood,
which leads to the danger of blood-borne pathogens, such as HIV or hepatitis,
to
contaminate the needle and pose a further health risk for the medical
personnel
administering the needle.
It would be beneficial to provide a needle that can be easily and quickly
placed
into a safety position after removal from the patient's blood vessel in order
to minimize
the chance for a needle stick.
SUMMARY OF THE INVENTION
Briefly, the present invention provides a catheter insertion needle assembly.
The
assembly includes a generally elongated body having a proximal end and a
distal end. A
needle guard is disposed at the distal end of the body in a needle guard
plane. A first
locking member is disposed proximate to the distal end of the body. A second
locking
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member is disposed at the proximal end of the body. A slider assembly includes
a slider body
being slidably disposed on the elongated body and further including a needle
having an
elongated needle body extending to a distal tip, and a cannulating portion
extending through the
elongated needle body. The needle extends distally of the slider and through
the needle guard.
A first locking tab is releasably engageable with the first locking member. A
second locking
portion is lockably engageable with the second locking member. The first
locking tab is
releasable from the first locking member to allow the slider to slide between
a distal position
relative to the elongated body wherein the tip extends distally of the needle
guard and a
proximal position relative to the elongated body wherein the tip is disposed
within the needle
guard plane. When the slider is disposed at the proximal position, the second
locking portion
engages the second locking member to preclude the slider from sliding distally
relative to the
elongated body, wherein the first locking member comprises a fixed portion
fixedly connected
to the body and a free portion movable between a locked position wherein the
first locking tab
is engaged with the first locking member and an unlocked position wherein the
first locking tab
is disengaged from the first locking member, and wherein the free portion is
biased toward the
locked position.
Further, the present invention provides a catheter insertion needle assembly
including a
generally elongated body; a needle guard disposed at the distal end of the
body in a needle
guard plane, and a slider assembly comprising a slider slidably disposed on
the elongated body
and a needle having an elongated needle body. A tip is disposed at a distal
end of the elongated
needle body and a cannulating portion extends through the elongated needle
body. The needle
extends distally of the slider and through the needle guard. A first retention
section for
releasably retaining the slider in a distal position relative to the elongated
body and a second
retention section for retaining the slider in a proximal position relative to
the elongated body
are also provided, wherein the distal end of the body comprises a sheath
retainer adapted to
releasably retain a catheter insertion sheath having a tubular body extending
therefrom, and
wherein the catheter insertion sheath comprises a tubular sheath body
extending distally
therefrom, and wherein, when the slider is in the distal position, the needle
is disposed within
the tubular sheath body such that the tip of the needle extends from the
tubular sheath body.
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BRIEF DESCRIPTION OF THE DRAWINGS
The accompanying drawings, which are incorporated herein and constitute part
of this
specification, illustrate the presently preferred embodiments of the
invention, and, together with
the general description given above and the detailed description given below,
serve to explain
the features of the invention. In the drawings:
Fig. 1 is a rear perspective view of a catheter insertion needle assembly
according to a
first embodiment of the present invention.
Fig. 2 is a sectional view of the catheter insertion needle assembly of Fig. 1
with
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a sheath shown in position in phantom.
Fig. 2A is a sectional view of the catheter insertion needle assembly of Fig.
1,
with the needle in a safety position retracted within the insertion sheath.
Fig. 3 is a sectional view of the catheter insertion needle assembly of Fig.
1, with
the needle in a retracted position and the sheath removed.
Fig. 4 is a rear perspective view of a catheter insertion needle assembly
according to a second embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION
In the drawings, like numerals indicate like elements throughout. Certain
terminology is used herein for convenience only and is not to be taken as a
limitation on
the present invention. The words "proximal" and "distal" refer to directions
away from
and closer to, respectively, the insertion tip of the needle in the catheter
insertion needle
assembly according to the present invention. The terminology includes the
words above
specifically mentioned, derivatives thereof, and words of similar import. The
following
describes preferred embodiments of the invention. However, it should be
understood
based on this disclosure, that the invention is not limited by the preferred
embodiments
described herein.
Referring to Fig. 1, a perspective view of a catheter insertion needle
assembly
100 according to a first embodiment of the present invention is shown. The
assembly 100
includes an elongate body 110, a slider assembly 120, a needle housing 126, a
needle
130, and a needle guard 140. The generally elongated body 110 has a distal end
112, a
proximal end 114, and a longitudinal axis 116 extending between the distal end
112 and
the proximal end 114. The body 110 also includes a proximal locking member 118
that
has a distal end 118a connected to the body 110 and a proximal free end 118b
that
extends beyond the plane of the body 110. A positive stop 115 extends downward
from
the proximal end 114, away from the longitudinal axis 116.
A slider assembly 120 is slidingly disposed on the body 110 for sliding
translation between the distal end 112 and the proximal end 114 of the body
110. The
slider assembly 120 includes a slider body 122 that includes a vertical or
first leg portion
123 and a horizontal or second leg portion 124 that extends perpendicularly
from the first
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leg portion 123. The first leg portion 123 includes a slot 125 that is sized
to allow the
body 110 to be slidingly disposed therethrough. The first leg portion 123 also
includes a
locking tab 121 that extends below slot 125, which may simply be defined by
the end of
the first leg portion. The slider assembly 120 further includes a needle
housing 126 that
extends through the first leg portion 123 along an axis 127 generally parallel
to the
longitudinal axis 116. The needle housing 126 includes a proximal portion 128
that
preferably includes a female luer fitting 129 and a distal needle portion or
needle 130
that includes a cannulating portion 132 with a needle tip 134. The needle tip
134 fluidly
communicates with the female luer fitting 129 to allow fluid and/or a catheter
guide wire
(not shown) to be transmitted through the needle housing 126.
Referring now to Fig. 2, the body 110 includes a needle guard 140 that is
disposed at the distal end 112 of the body 110. The needle guard 140 extends
in a plane
preferably generally perpendicular to the longitudinal axis 116 of the body
110 and
includes a preferably generally circular opening 142 that extends through the
needle
guard 140 generally parallel to the longitudinal axis 116 of the body 110. As
seen in Fig.
3, a seal 144 maybe disposed within the opening 142 along the plane of the
needle guard
140. The seal 144 may be constructed from silicone, or from some other
compatible
polymer. The seal 144 serves to encapsulate the needle tip 134 after needle
use, as will
be described in more detail herein.
Referring back to Fig. 2, the needle guard 140 further includes a sheath
retainer
146 disposed on a distal end of the needle guard 140. The sheath retainer 146
is sized
and shaped to allow a needle sheath, such as the needle sheath 160, to be
slidably
disposed on the sheath retainer 146. Optionally, a tubular safety sheath 162
(shown in
dashed lines) may be disposed over the needle sheath 160 and the cannulating
portion
132 of the needle housing 126 to prevent accidental sticking prior to use.
A first locking member 150 is disposed proximate to the distal end 112 of the
elongated body 110. The first locking member 150 includes a fixed portion 152
that
extends away from the body 110 preferably generally perpendicularly to the
longitudinal
axis 116 of the body 110. A free portion 154 of the first locking member 150
extends
from the fixed portion 152 generally parallel to the longitudinal axis 116 of
the body 110
and toward the proximal end 114 of the body 110. The free portion 154 of the
first
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locking member 150 preferably includes a first tapered portion 156 that tapers
from a
larger distal end 156a to a narrower proximal end 156b. An open space 158 is
formed
between the fixed portion 152 and the distal end 156a of the first tapered
portion 156 that
is sized to retain the locking tab 121 of the slider assembly 120. A second
tapered portion
157 extends proximally from the first tapered portion 156. A detent 159 is
formed
between the first tapered portion 156 and the second tapered portion 157. The
detent 159
allows the slider assembly 120 to be partially drawn distally so that the
needle tip 134 is
drawn into the needle sheath 160 prior to insertion of the needle 130 into the
patient.
The free portion 154 of the first locking member 150 is able to be biased away
from the body 110 to disengage the locking tab 121 of the slider assembly 120
from the
free portion 154 of the first locking member 150 in order to enable the slider
assembly
120 to be disposed proximally along the body 110.
Preferably, both the body 110 and the slider assembly 120 are constructed from
as suitable polymer, such as polystyrene or ISOPLAST polyurethane sold by Dow
Corning of Midland, MI although those skilled in the art will recognize that
the body 110
and the slider 120 may be constructed from other materials instead.
Initially, the slider assembly 120 is disposed toward the distal end of the
body
110, such that the locking tab 121 is disposed within the open space 158, such
as is
shown in Figs. 1 and 2. The free portion 156 of the first locking member 150
retains the
locking tab 121 within the open space 158. In this position, the needle (130)
extends
distally of the body 110 and of the needle guard 140. Preferably, the sheath
160 is
disposed over the cannulating portion 132 of the needle and the tubular
protector 162 is
disposed over the sheath 160 and the cannulating portion 132 of the needle
such that the
needle tip 134 of the needle is covered by the protector 162 to prevent
accidental sticking
by the needle.
When the medical personnel is ready to administer the insertion of the needle,
the medical personnel biases the free portion 154 of the first locking member
150 away
from the longitudinal axis 116 of the body 110 until the distal end 156b of
the first
tapered portion 156 of the first locking member 150 clears the locking tab 121
of the
slider assembly 120. The slide' assembly 120 is then disposed proximally along
the body
110 to the position shown in Fig. 2A. The locking tab 121 of the slider
assembly 120 is
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now secured within the detent 159. The needle tip 134 of the needle 130 is now
safely
disposed within the needle sheath 160 and the medical personnel is not in
danger of an
accidental needle stick.
The tubular safety sheath 162 is then removed from the needle and the sheath
160 by sliding the tubular safety sheath 162 distally along the length of the
needle until
the tubular safety sheath 162 is removed therefrom. The tubular safety sheath
162 is no
longer needed and may be discarded. The needle housing 126 is slid distally
until the
locking tab 121 locks into the open space 158, allowing the needle tip 134 to
extend
distally of the sheath 160. The cannulating portion 132 of the needle is then
inserted into
the desired location in a patient according to methods well known in the art.
When it is desired to withdraw the needle from the patient, the free portion
154
of the first locking member 150 is biased away from the longitudinal axis 116
of the
body 110 until the distal end 156b of the free portion 154 of the first
locking member 150
clears the locking tab 121 of the slider assembly 120. The slider assembly 120
is then
disposed proximally along the body 110 to the position shown in Fig. 3,
further
disposing the needle 130 proximally along the body 110 as well.
As the slider assembly 120 is disposed toward the proximal end 114 of the body
110, the slider assembly 120 engages the proximal locking member 118,
depressing the
proximal end 118b toward the longitudinal axis 116. As the proximal locking
member
118 clears the slot 125, the proximal end 118b of the proximal locking member
118
biases back to its original position, again extending out of the plane of body
110 but now
distally of first leg portion 123, which now acts as a second locking portion,
preventing
the slider assembly 120 from being disposed distally beyond the proximal
locking
member 118. Preferably generally simultaneously, the distal tip 134 of the
needle is
disposed proximally through the sheath 160 and into the needle guard 140,
where the
needle guard 140 prevents a user from being accidentally stuck. If the
optional seal 144
is used, the distal tip 134 of the needle assembly 126 is disposed within the
seal 134 as a
further safety precaution. To prevent the slider assembly 120 from being
pulled off of the
body 110, the stop 115 engages the locking tab 121 if the locking tab 121 is
slid too far
proximally along the body 110.
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At this point, the distal tip 134 of the needle is fully retracted from the
sheath 160, and
the sheath 160 may be slidingly removed from the sheath retainer 146, by
sliding the sheath
160 in a direction toward either the top or bottom of the page of Fig. 3, as
is well known to
those skilled in the art. The sheath 160 remains inserted into the patient,
and the assembly 100
may now be disposed in a medical waste container or other suitable container.
An alternate embodiment of a catheter needle insertion assembly 200, shown in
Fig. 4,
is similar to the catheter needle insertion assembly 100 described above and
shown in Figs. 1-3,
with the exception of the first locking member 150, which has been replaced by
a first locking
member 250, shown in Fig. 4. The first locking member 250 is disposed to the
side of the
syringe 226 such that, to release the syringe 226 from the first locking
member 250, the
proximal end 256a of the free portion 254 of the first locking member 250 is
biased away from
the proximal end 228 of the syringe 226 until the distal end 256b of the free
portion 254 of the
first locking member 250 clears the locking tab 221 of the slider 220. The
slider 220 is then
disposed proximally along the body 210, further disposing the syringe 226
proximally along the
body 210 as well. The remaining operation of the assembly 200 is identical to
the operation of
the assembly 100 as described above.
It will be appreciated by those skilled in the art that changes could be made
to the
embodiments described above without departing from the broad inventive concept
thereof.
