Note: Descriptions are shown in the official language in which they were submitted.
CA 02247402 2002-10-11
DE~CR,IIPTIOI~
VALVE AB~EMBLY
BA~CKiGROUND OF THE tN~l~_N_T~,f)N
The present invention is related to a valve assembly. More specifically, the
invention is
directed to a valve assembly for use in the regulation of fluid flow to and
from a blood vessel.
Valve assemblies for various medical uses are known in the art. Examples of
such
assemblies are disclosed in U.S. Patent Nos. 4,254,773; 4,683,916; 5,171,230;
5,242,393; and
5,405,323.
The US-patent 5,390,898 discloses a dual direction check valve, which is
adapted to
io reliably block the backflow of blood through a needle during the
interconnection and start-up of
an intravenous system. A resilient valve core formed of an elastomerlc
material has a
peripheral sealing surtace extending there around. The check valve is closed
to fluid flow in
both directions when the sealing surface of the valve core mates against a
complementary
peripheral sealing surface which surrounds the valve core. The check valve is
opened to fluid
flow in both directions when an axial pushing force is applied to the valve
core, whereby the
valve core is compressed and the sealing surtace thereof is separated from its
complementary
sealing surface to establish a gap there between.
The EP-0 696 461 discloses a valve adapter for a n~dical access device that
includes a
body with a longitudinal axis. The body has a proximal first end, a distal
second end and a
2o passageway there through which has an inside surface. The passageway has a
chamber
defined by a proximal shoulder and a segmented distal shoulder. The adapter
includes a valve
contained within the chamber for selectively obstructing and allowing fluid
flow through the
passageway. The valve includes an elongate resilient member, which is axially
compressed
between the distal shoulder and the proximal shoulder, the compression biasing
the valve to a
normally closed position. The proximal end of the resilient member forms a
substantially fluid
tight seal with the proximal shoulder which obstructs fluid flow through the
passageway. The
i
CA 02247402 2002-10-11
adapter further includes a pusher for selectively further axially compressing
the resilient member
so that the proximal end of the adapter no longer forms a fluid tight seal
with the proximal
shoulder thereby allowing fluid flow through the passageway.
It has been found that there is a need for a valve assembly that provides a
superior seal
within the assembly to prevent leakage. There is also a need far a valve
assembly that can be
used with a sharp. Examples of sharps include needles and trocars. The present
invention
satisfies the above-identified needs.
SUAI~IA~ F T EH INVENTION
io The present invention is directed to a valve assembly having a body. The
body has a
first end, a second end, an exterior surface and an interior surface. The
interior surface defines
a body fluid passageway extending between the first and second ends. The
interior surtace
defines a chamber having a cylindrical side wall adjacent the first end. The
cylindrical side wall
defines a plurality of fluid recesses. The interior surtace defines an annular
septum shoulder
adjacent the cylindrical side wall.
An end cap is positioned adjacent the first end of the body. The end cap is in
communication with the chamber of the body. The end cap has an attachment end,
a body end,
an outer surtace and an inner surface. The inner surface defines an end cap
fluid passageway
extending between the attachment end and the bay end, A catheter or
intravenous {IV) luer
2o fitting can be attached to the attachment end. The body end includes a
plurality of spaced
outwardly extending projections adjacent the end cap fluid passageway. The
projections are
adjacent the chamber of the body.
The assembly further includes a septum or seal that has a shoulder surtace and
an
opposed projections surface. The septum has a substantially circular chamber
wall extending
between the shoulder and projections surfaces. The shoulder surface engages
the septum
shoulder of the body to form a seal when the valve is in a closed position.
The projections
2
CA 02247402 2002-10-11
surtace engages the projections. The chamber wall is adjacent the cylindrical
side wall of the
chamber. The chamber wall and the fluid recesses form a plurality of chamber
fluid
passageways.
An actuator is positioned in the bay fluid passageway adjacent the second end
of the
s body. The actuator moves the shoulder surtace of the septum away from the
septum shoulder
of the body to allow fluid to flow through the body fluid passageway, the
chamber fluid
passageways and the end cap fluid passageway.
The assembly can include a sharp, such as a needle, having a first needle-end,
a
second needle end, a needle exterior surface and a needle inferior surface.
The needle interior
1o surface defines a needle fluid passageway extending between the first
needle end and the
second needle end. The needle extends through the actuator, the septum and the
end cap fluid
passageway. If a catheter is attached to the attachment end of the end cap,
the needle extends
through the catheter fluid passageway.
It is the primary object of the present invention to provide a valve assembly
that has a
15 superior seal within the assembly for preventing leakage of fluid.
It is an important object of the present invention to provide a valve assembly
that can be
used with a sharp.
Other objects and advantages of the present invention shall become apparent to
those
skilled in the art upon a review of the following detailed description of the
preferred
2o embodiments and the accompanying drawings.
BRIEF DESCRIPTION, OF THE D WLNGS
Fig. 1 is a cross-sectional view taken through the center of a first
embodiment valve
assembly according to the present invention including a needle and a catheter;
25 Fig. 2 is an exploded view showing the body, septum and end cap of the
present
invention;
3
CA 02247402 2002-10-11
Fig. 3 is a aoss-sectional view taken along line 3-3 of Fig. 7 showing the
assembly
according to the present invention in a sealed position;
Fig. 4 is a cross-sectional view taken along line 4-4 of Fig. 8 showing the
assembly in an
open position;
Fig. 5 is a cross-sectional view taken along line 5-5 of Fig. 7 showing the
assembly in a
sealed position;
Fig. 6 is a cross-sectional view taken along line 6-~6 of Fig. 8 showing the
assembly in an
open position;
Fig. 7 is a cross-sectional view taken along line 7-7 of Fig. 3;
1o Fig. 8 is a cross-sectional view taken along line 8-8 of Fig. 4;
Fig. 9 is a cross-sectional view taken through the center of a second
embodiment of the
valve assembly according to the present invention including a catheter;
Fig. 10 is a view similar to the view of Fig. 9 further including a needle;
Fig. 11 is a view similar to the view of Fig. 9 showing the assembly in an
open position;
Fig. 12 is a perspective view of a second embodiment actuator;
Fig. 13 is a perspective view of a second embodiment body;
Fig. 14 is a perspective view of a second embodiment end cap; and
Fig. 15 is a cross-sectional view taken through the center of the second
embodiment
assembly including a needle, needle guard assembly and catheter.
DETAIL- D CRI T14N T P R DIM TS
The preferred embodiments and best mode of the present invention shall now be
described in detail with reference being made to the accompanying drawings.
The valve
assembly of the present invention is indicated generally in the drawings by
the reference
number "10". As shown in Fig. 1, the assembly 10 includes a body 12, an end
cap 14, a
septum 16 and an actuator 20. Depending on the use of the present invention,
the assembly 10
a
CA 02247402 2002-10-11
can also inGude a catheter 18 and a sharp, such as a needle 22. Referring to
Figs. 1 and 2, the
body 12 has a first end 30, a second end 32, an exterior surface 34 and an
interior surface 36.
The interior surface 36 defines a body fluid passageway 38 extending between
the first and
second ends 30 and 32. The interior surface 36 defines a chamber 40 having a
cylindrical side
wall 42 adjacent the first end 30. As shown in Figs. 2, 5 and 7, the
cylindrical 25 side wall 42
defines a plurality of fluid recesses 44. In the present embodiment, there are
four fluid recesses
44 defined by the cylindrical side wall 42. It should be understood that any
number of fluid
recesses 44 can be defined by the side waN 42. As shown in Fig. 1, the
interior surface 36
defines an annular septum shoulder 46 adjacent the chamber 40 of the body 12.
The interior
1o surtace 36 further defines an annular actuator shoulder 48 adjacent the
septum shoulder 46 in
the body fluid passageway 38.
Referring now to Figs. 1, 2 and 4, the exterior surface 34 of the body 12
includes a luer
attachment fitting 50. The leer attachment fitting 50 includes luer attachment
members 52 and a
luer tapered fitting 54. The luer attachment fitting 50 is positioned on the
second end 32 of the
i5 body 12. The luer attachment fitting 50 can be the type set forth in
American National Standard
Institute No. ANSUHIMA MD70.1 -1983.
As shown in Figs. 1 and 2, the end cap 14 is positioned adjacent the first end
30 of the
body 12. The end cap 14 is in communication with the chamt~f 40 of the body
12. The end
cap 14 has an attachment end 56, a body end 58, an outer surface 60 and an
inner surface 62.
2o The inner surface 62 defines an end cap fluid passageway 64 that extends
between the
attachment end 56 and the body end 58.
Referring to Fig. 2, the body end 58 of the end cap 14 includes an annular
face 66. The
opening 68 of the end cap fluid passageway 64 is positioned in the center of
the annular
face 66. A plurality of spaced oufinrardly extending projections 70 are
positioned on the annular
2s face 66. In the present embodiment, there are four projections 70. Each of
the projections 70 is
in the shape of a sector having first and second equidistant sides 72 and 74,
and an arc 76.
5
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The arcs 76 of the projections 70 generally define a circle with the center of
the circle being the
opening 68. The projections 70 encompass the opening 68. As shown in Fig. 2,
the projections
70 define a plurality of channels 78. In the present embodiment, four channels
78 are defined
by the four projections 70. As described below, the channels 78 are used to
channel fluid to the
s opening 68. As shown in Figs. 1, 2 and 6, the projections 70 are positioned
in the chamber 40
adjacent the cylindrical side wall 42 of the body 12. The projections 70 are
positioned so that
the channels 78 are in communication with the fluid recesses 44. As shown in
Fig. 2, each of
the projections 70 includes a flat septum surface 80.
Referring now to Figs. 1, 2, 7 and 8, the septum 16 has a shoulder surface 84
and an
opposed projections surface 86. A circular chaml~r wall 88 extends between the
shoulder and
projections surfaces 84 and 86. The shoulder surface 84 engages the septum
shoulder 46
defined by the body 12 to form a seal when the assembly 10 is in a sealed
position. The
projections surface 86 engages the septum surfaces 80 of the projections 70.
The septum
surfaces 80 provide flat surfaces upon which the septum 16 can be seated.
1s As shown in Figs. 7 and 8, the chamber wall 88 of the septum 16 is
positioned adjacent
the cylindrical side wall 42 and fluid recesses 44 of tha chamber 40. When so
positioned, the
chamber wall 88 and the fluid recesses 44 form a plurality of chamber fluid
passageways 90. In
the present embodiment, four chamber fluid passageways 90 are formed.
The septum 16 is made of a resilient, compressible elastorneric material. The
septum
16 should be made of a material that can be compressed or deformed numerous
times without
losing its original shape. The material used should also allow the septum 16
to be pierced by a
sharp, such as a needle 22, as described below, and be self-sealing after
removal of the sharp.
An example of a material that can be used to make the septum 16 is a
biocompatible synthetic
polymer material.
2s As shown in Fig. 1, the catheter 18 is positioned on the atta~ment end 56
of the end
cap 14 by a catheter fitting 92. The catheter fitting 92 can be the type set
forth in American
6
CA 02247402 2002-10-11
National Standard Institute No. ANSI/HIMA MID70.1-1983. The catheter 18 can
also be directly
attached to the end cap 14 (not shown). As shown in Fig. 3, a catheter fluid
passageway 94
extends through the catheter 18.
Referring to Figs. 1, 3 and 4, the actuator 20 includes a first actuator end
96, a second
s actuator end 98, an exterior actuator surface 100 and an interior actuator
surface 102. The
interior actuator surface 102 defines an actuator fluid passageway 104
extending between the
first actuator end 96 and the second actuator end 98. The actuator 20 further
includes a second
fluid passageway 106 that extends perpendicular to the first actuator fluid
passageway 104. The
second actuator fluid passageway 106 consists of openings 108 and 1 10 that
each extends
1o from the interior actuator surface 102 to the exterior actuator surface
100. As shown in Figs. 3
and 4, the actuator exterior surface 100 defines an annular septum contact
surface 112 and an
opposed actuator shoulder contact surface 114. The septum contact surface 112
engages the
shoulder surface 84 of the septum 16. The actuator shoulder contact surface
114 engages the
actuator shoulder 48 of the body 12. The actuator 20 is positioned in the body
fluid passageway
1s 38 adjacent the second end 32 of the body 12.
Referring to Fig. 1, the needle 22 includes a first needle end 120, a second
needle end
122, a needle exterior surface 124 and a needle interior surface 126. The
needle interior
surface 126 defines a needle fluid passageway 128 extending between the first
needle end 120
and the second needle end 122. The needle 22 includes a sharp point 130 at the
first needle
2o end 120. During the manufacture of the assembly 10, the point 130 pierces
the septum 16 to
allow the needle 22 to be inserted through the septum. When the assembly 10 is
used, the
point 130 is used to pierce the skin and blood vessel of a patient. A handle
132 is positioned
adjacent the second needle end 122. The handle 132 includes an actuator end
134 adjacent
the second actuator end 98 of the actuator 20. The handle 132 includes an
indicator channel
25 136 that is in communication with the needle fluid pass~eway 128. The
handle 132 can be
made of a transparent material, such as dear plastic. The handle 132 is
transparent so that one
CA 02247402 2002-10-11
using the assembly 10 can readily see blood or other fluid once the needle 22
is properly
inserted. As shown in Fig. 1, the needle 22 extends through the actuator fluid
passageway 104,
the septum 16, the end cap fluid passageway 64 and the catheter fluid
passageway 94.
The use of the assembly 10 of the present invention will now be described.
Referring to
s Figs. 1 and 3 through 8, one using the assembly 10 locates a blood vessel on
a patient's body.
The point 130 of the needle 22 and the catheter 18 are inserted through the
skin and blood
vessel of the patient. Once the needle 22 is in the blood vessel, blood
"flashes" through the
needle fluid passageway 128, in the direction shown by the arrows in Fig. 1,
to the indicator
channel 136 of the handle 132. Once blood is seen in the Indicator channel
136, the needle 22
io is removed from the assembly 10 by pulling the handle 132 away from the
second end 32 of the
body 12. In so doing, the needle 22 is removed ftom the catheter fluid
passageway 94, the end
cap fluid passageway 64, the septum 16, the actuator fluid passageway 104 and
the body fluid
passageway 38. The needle 22 is then discarded. After removal of the needle 22
from the
blood vessel, the catheter 18 remains positioned in the blood vessel.
is Referring to Figs. 3 and 5, a seal is formed between the septum shoulder 46
of the body
12 and the shoulder surface 84 of the septum 16. The seal is tight because the
shoulder
surface 84 of the septum 16 is forced against the septum shoulder 46 due to
the resilient nature
of the septum and the contact of the projections surface 8fi against the
projections 70.
Therefore, any blood flowing in the direction of the arrows shown in Fig. 3
will be prevented by
2o the seal from escaping into the body fluid passageway 38 of the body 12.
This prevents blood
from exiting the second end 32 of the body 12.
Referring to Figs. 4, 6 and 8, a male lust 140, which is attached to
intravenous tubing or
other apparatus (not shown), can be attached to the second end 32 of the body
12. The
lust 140 mates with the leer 9 attachment frtting 50 by rotating the lust
tapered fitting 54 into the
2s lust 140 until recesses 142 engage the lust attachment projections 52. The
lust 140 includes a
male member 144 that is inserted in the body fluid passageway 38. The male
member 144
a
CA 02247402 2002-10-11
engages the second actuator end 98 of the actuator 20. The engagement of the
male
member 144 with the second actuator end 98 causes the septum contact surface
112 of the
actuator 20 to engage and press against the shoulder surface 84 of the septum
16. Due to the
resilient nature of the septum 82, the shoulder surface 84 becomes disengaged
from the
septum shoulder 46 of the body 12. This breaks the seal between the shoulder
surface 84 and
the septum shoulder 46. As shown by the arrows in Fig. 6, fluid is free to
flow from the luer 140
through the first actuator fluid passageway 104 to the openings 108 and 110 of
the second
actuator fluid passageway 106 through the chamber fluid passageways 90 to the
channels 78
through the end cap fluid passageway 64 and to the catheter fluid passageway
94 into the blood
io vessel. Fluid can also flow in the opposite direction. The assembly 10 can
be resealed by
removing the luer 140 from the second end 32 of the body 12 thereby causing
the septum 16 to
regain its original shape to form a seal between the shoulder surface 84 and
the septum
shoulder 46. Upon removal of the luer 140, the axial movement of the actuator
20 is restricted
when the shoulder contact surface 114 engages the actuator shoulder 48 of the
body 12.
The description of the assembly 10 has included a catheter 18 and a needle 22.
It
should be understood that the present invention can also be used as a valve in
a needleless
access system. In this type of system, the attachment end 56 of the end cap 14
could include a
luer attachment fitting of the type set forth in American National Standard
Institute No.
ANSI/HIMA MD70.1-1983. This would allow the attachment end 56 to mate with a
luer in
2o communication with, for example, IV tubing. The second end 32 of the body
12 indudes a luer
attachment fitting 50, as previously described, so that a luer 140 in
communication with, for
example, IV tubing can be attached to the body 12. When the valve assembly 10
is used in a
needleless access system, fluid is free to flow from the luer 140 through the
first actuator fluid
passageway 104 to the openings 108 and 110 of the second actuator fluid
passageway 106
through the chamber fluid passageways 90 to the channels 78 through the end
cap fluid
passageway 64 and to the luer attached to the attachment end 56 of the end cap
14. The
9
CA 02247402 2002-10-11
assembly 10 can be resealed by removing the luer 140 from the body 12. This
would cause the
septum 16 to engage the septum shoulder 46 as previously described to seal the
assembly 10.
A second embodiment of the valve assembly 10 of the present invention is shown
in
Figs. 9 through 15. Referring to Figs. 9 thn~ugh 11, the second embodiment
assembly 10
includes a body 212, an end cap 214, a septum 216 and an actuator 220. As
shown in Fig. 10,
the assembly 10 can also include a catheter 218 and a sharp, such as a needle
222. It should
be understood that the assembly 10 can be used as a valve in a needleless
access system
without a catheter 218 or needle 222 as previously described.
Referring to Figs. 9 and 13, the body 212 has a first end 230, a second end
232, an
io exterior surtace 234 and an interior surface 236. The interior surtace 236
defines a body fluid
passageway 238 extending between the first and second ends 230 and 232. The
interior
surface 236 defines a chamber 240 having a cylindrical side wall 242 adjacent
the first end 230.
As shown in Fig. 13, the cylindrical side wall 242 defines a plurality of
longitudinally extending
chamber members 243 that define a plurality of fluid recesses 244. In the
second embodiment,
i5 there are six chamber members 243 that define six fluid recesses 244. It
should be understood
that any number of fluid recesses 244 can be defined by the chamber members
243. As shown
in Figs. 9 and 13, the interior surtace 236 defines an annular septum shoulder
246 adjacent the
chamber 240 of the body 212.
Still referring to Figs. 9 and 13, the exterior surtace 234 of the body 212
includes a luer
2o attachment fitting 250. The luer attachment fitting 250 includes luer
attachment members 252
and a luer tapered fitting 254. The leer attachment fitting 250 is positioned
on the second end
232 of the body 212.
Referring to Figs. 9 and 14, the end cap 214 is positioned adjacent the first
end 230 of
the body 212. The end cap 214 is in communication with the chamber 240 of the
body 212.
2s The end cap 214 has an attachment end 25fi, a body end 258, an outer
surtace 260 and an
inner surtace 262. The inner surtaoe 262 defines an end cap fluid passageway
264 that
CA 02247402 2002-10-11
extends between the attachment end 256 and the body end 258. As shown in Fig.
9, the
attachment end 256 can include a plurality of threads 265 for receiving the
catheter 218. It
should be understood that the attachment end 256 can include a variety of
attachment devices
or fittings depending on the use of the assembly 10. For example, the
attachment end 256 can
s include a luer attachment fit~ng for mating engagement with a luer.
As shown in Fig. 14, the body end 258 of the end cap 214 includes an annular
face 266.
The opening 268 of the end cap fluid passageway 264 is posi#ioned in the
center of the annular
face 266. A plurality of spaced outwardly extending end cap projections 270
are positioned on
the annular face 266. In the present embodiment, there are five end cap
projections 270. The
io end cap projections 270 encompass the opening 268. The end cap projections
270 define a
plurality of channels 278. In the present embodiment, eve channels 278 are
defined by the five
end cap projections 270. The channels 278 are used to channel fluid to the
opening 268. As
shown in Fig. 9, the end cap projections 270 are positioned in the chamber 240
adjacent the
cylindrical side wall 242 of the body 212. The end cap projections 270 are
positioned so that
15 the channels 278 are in communication with the fluid recesses 244. As shown
in Fig. 14, each
of the end cap projections 270 includes a flat septum surface 280.
As shown in Fig. 9, the septum 216 has a shoulder surface 284 that defines an
actuator
recess 285. The septum 216 further includes a projections surface 286 that
defines an end cap
recess 287. A circular chamber wall 288 extends between the shoulder and
projections
2o surfaces 284 and 286. The shoulder surface 284 engages the septum shoulder
246 defined by
the body 212 to form a seal when the assembly 10 is in a sealed position. The
projections
surface 286 engages the septum surfaces 280 of the projections 270. The septum
216 is
pre-loaded in the chamber 240 in order to properly seat the septum in the
assembly 10. As
shown in Fig. 9, the positive pressure resulting from the preloading causes
portions of the
25 projections surface 286 of the septum 216 to extend beyond the septum
surfaces 280 of end
projections 270. The extending portions of the projections surface 286 do not
contact the
11
CA 02247402 2002-10-11
annular face 266 of the end cap 214 to interfere with the flow of fluid 20
through the
assembly 10.
As shown in Figs. 9 and 11, the chamber wall 288 of the septum 216 is
positioned
adjacent the cylindrical side wall 242 and fluid recesses 244 of the chamber
240. When so
s positioned, the chamber wall 288 and the fluid recesses 244 form a plurality
of chamber fluid
passageways 290. In the present embodiment, six chamber fluid passageways 290
are formed.
Referring to Fig. 9, the septum 216 is made of a resilient, compressible
elastomeric
material. The septum 216 should be made of a material that can be compressed
or deformed
numerous times without losing its original shape. The material used should
also allow the
1o septum 216 to be pierced by a sharp, such as a needle 222, and be self-
sealing after removal of
the sharp. As previously described, an example of a material that can be used
to make the
septum 216 is a biocvmpatible synthetic polymer material.
Referring to Fig. 9, the catheter 218 is positioned on the attachment end 256
of the end
cap 214 by a catheter fitting 292. The catheter fitting 292 includes a
plurality of threads 293 that
is mate with the threads 265 of the end cap 214. The catheter 218 includes a
catheter fluid
passageway 294.
Referring to Figs. 9 and 12, the actuator 220 includes a first actuator end
296, a second
actuator end 298, an exterior actuator surface 300, and an interior actuator
surface 302. The
interior actuator surface 302 defines a needle passageway 304 extending
between the first
2o actuator end 296 and the second actuator end 298. The interior actuator
surface 302 defines a
fluid passageway 306 adjacent the second actuator end 298. As shown in Figs. 9
and 12, the
actuator exterior surface 300 defines an annular septum contact surface 312
and an opposed
fitting contact surface 314. A portion of the exterior surface 300 and the
septum contact
surface 312 engage the actuator recess 285 of the septum 216. As shown in Fig.
11, the fitting
25 contact surface 314 engages, for example, the male member 144 of a luer
140. The
12
CA 02247402 2002-10-11
actuator 220 is positioned in the body fluid passageway 238 adjacent the
second end 232 of the
body 212.
Referring to Fig. 10, the needle 222 includes a first needle end 320, a second
needle
end 322, a needle exterior surface 324 and a needle interior surface 326. The
needle interior
surface 326 defines a needle fluid passageway 328 extending between the first
needle end 320
and the second needle end 322. As shown in Fig. 10, the needle 322 extends
through the
needle passageway 304 of the actuator 220, the septum 216, the end cap fluid
passageway 264
and the catheter fluid passageway 294.
Referring to Fig. 15, an embodiment of a combined needle handle and guard 332
is
1o shown. The handle 332 includes a first handle end 334 and a second handle
end 336. The first
end 334 is attached to the second end 232 of the body 212. The second needle
end 322 of the
needle 222 is attached to a reciprocating handle member 338. When the needle
222 is to be
removed from the assembly 10, the handle member 338 is moved from the first
end 334 of the
handle 332 toward the second end 336. When the handle member 338 is adjacent
the second
end 336, the needle 222, including the sharp point 330, is completely
retracted into the body of
the handle 332. The handle 332 can then be removed from the assembly 10 and
discarded.
Once the handle 332 is removed, the second end 232 of the body 212 can
receive, for example,
a luer.
The use of the second embodiment assembly 10 of the present invention will now
be
2o described. Referring to Figs. 10 and 15, one using the assembly 10 locates
a blood vessel on
the patient's body. The point 330 of the needle 222 and the catheter 218 are
inserted through
the skin and blood vessel of the patient. Once the needle 222 is in the blood
vessel, blood
"flashes" through the needle fluid passageway 328, in the direction shown by
the arrows in
Fig. 10. The needle 222 is removed from the assembly 10 by pulling the handle
member 338
toward the second end 336 of the handle 332. This causes the needle 222 to be
removed from
the catheter fluid passageway 294, the end cap fluid passageway 264, the
septum 216, the
13
CA 02247402 2002-10-11
needle passageway 304 and the body fluid passageway 238. The handle 332 is
then removed
from the body 212 and discarded. After removal of the needle 222 from the
blood vessel, the
catheter 218 remains positioned in the blood vessel.
Referring to Fig. 9, a seal is formed between the septum shoulder 246 of the
body 212
and the shoulder surface 284 of the septum 216. Therefore, blood will be
prevented by the seal
from escaping into the body fluid passageway 238 of the body 212. This
prevents blood from
exiting the second end 232 of the body 212.
Referring to Fig. 11, a male lust 140 can be attached to second end 232 of the
body 212. The lust 140 mates with the lust attachment fitting 250 by rotating
the lust tapered
1o fitting 254 into the lust 140 until recesses 142 engage the lust attachment
projections 252. The
lust 140 includes a male member 144 that is inserted in the body fluid
passageway 238. The
male member 144 engages the second actuator end 298 of the actuator 220. The
engagement
of the male member 144 with the second actuator end 298 causes the septum
contact surface
312 of the actuator 220 to engage and press against the actuator recess 285 of
the resilient
septum 216. This causes the shoulder surface 284 to be disengaged from the
septum
shoulder 246 of the body 212. This breaks the seal between the shoulder
surface 284 and the
septum shoulder 246. As shown in Fig. 11, fluid is free to flow from the lust
140 through the
fluid passageway 306 of the actuator 220 to the chamber fluid passageways 290
to the
channels 278 through the end cap fluid passageway 264 and to the catheter
fluid passageway
294 into the blood vessel. The assembly 10 can be resealed by removing the
lust 140 from the
second end 232 of the body 212 thereby causing the septum 216 to regain its
original shape to
form a seal between the shoulder surface 284 and the septum shoulder 246.
While the invention has been described with reference to preferred
embodiments, it
should be understood by those skilled in the art that various changes may be
made and
equivalents rnay be substituted for elements thereof without departing from
the essential scope
of the invention. In addition, many modifications may be made to adapt a
particular situation or
14
CA 02247402 2002-10-11
material to the teachings of the invention without departing from the
essential scope thereof.
Therefore, it is intended that the invention not be limited to tile particular
embodiments disclosed
as the best mode contemplated for carrying out this invention, but that the
invention will include
all embodiments falling within the scope of the claims.
s
12247786.1
is
