U.S. patent application number 15/011981 was filed with the patent office on 2016-08-04 for intravenous catheter assembly design.
The applicant listed for this patent is Smiths Medical ASD, Inc.. Invention is credited to Harsh Chheda, David Goral, Christopher Roehl.
Application Number | 20160220805 15/011981 |
Document ID | / |
Family ID | 56544466 |
Filed Date | 2016-08-04 |
United States Patent
Application |
20160220805 |
Kind Code |
A1 |
Goral; David ; et
al. |
August 4, 2016 |
INTRAVENOUS CATHETER ASSEMBLY DESIGN
Abstract
An intravenous catheter assembly. The intravenous catheter
assembly including a catheter and a catheter hub having a catheter
hub body, a septum, and a septum retainer, the catheter hub body
having an internal wall defining a transition step, wherein the
septum positioned such that a first end of the septum abuts up
against the transition step, the septum retainer at least partially
insertable within the catheter hub body and configured to secure
the septum in position.
Inventors: |
Goral; David; (Brookfield,
CT) ; Roehl; Christopher; (New Hartford, CT) ;
Chheda; Harsh; (Cheshire, CT) |
|
Applicant: |
Name |
City |
State |
Country |
Type |
Smiths Medical ASD, Inc. |
Rockland |
MA |
US |
|
|
Family ID: |
56544466 |
Appl. No.: |
15/011981 |
Filed: |
February 1, 2016 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
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62109715 |
Jan 30, 2015 |
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62109722 |
Jan 30, 2015 |
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62109742 |
Jan 30, 2015 |
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62109745 |
Jan 30, 2015 |
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62109750 |
Jan 30, 2015 |
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62109755 |
Jan 30, 2015 |
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62109735 |
Jan 30, 2015 |
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62109673 |
Jan 30, 2015 |
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62109710 |
Jan 30, 2015 |
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62109759 |
Jan 30, 2015 |
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62109766 |
Jan 30, 2015 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61B 5/150259 20130101;
A61B 5/150732 20130101; A61M 21/02 20130101; A61B 5/157 20130101;
A61M 39/22 20130101; A61M 25/0097 20130101; A61B 5/150221 20130101;
A61B 5/150389 20130101; A61B 2010/0006 20130101; A61B 17/1325
20130101; A61M 2205/0205 20130101; A61M 2021/0016 20130101; A61B
5/150641 20130101; A61B 5/1477 20130101; A61B 5/145 20130101; A61B
5/150503 20130101; A61M 5/3202 20130101; A61M 25/0693 20130101;
A61B 5/14539 20130101; A61B 5/15003 20130101; A61B 5/150824
20130101; A61B 5/1535 20130101; A61M 25/0631 20130101; A61M 5/422
20130101; A61B 5/150992 20130101; A61B 5/150213 20130101 |
International
Class: |
A61M 39/22 20060101
A61M039/22; A61M 25/00 20060101 A61M025/00 |
Claims
1. An intravenous catheter assembly, comprising: a catheter having
a first end for insertion into a biological site, a second end and
a flexible wall defining a lumen extending therebetween; and a
catheter hub including-- a catheter hub body having a first end
operably coupled to the second end of the catheter, a second end,
and an internal wall defining an internal fluid passageway
therebetween, the internal wall further defining a transition step
within the internal fluid passageway between a smaller diameter
portion of the internal fluid passageway proximal to the first end
and a larger diameter portion of the internal fluid passageway
proximal to the second end; a septum having a first end and a
second end, wherein the septum is positioned within the internal
fluid passageway such that the first end of the septum abuts up
against the transition step; and a septum retainer at least
partially insertable within the internal fluid passageway of the
catheter hub body and configured to secure the septum in position
within the internal fluid passageway, the septum retainer having a
outer wall shaped and sized to interlock with the internal wail of
the catheter hub body.
2. The intravenous catheter assembly of claim 1, wherein the
internal wall of the catheter body further defines a side port,
wherein the side port is in fluid communication with the internal
fluid passageway.
3. The intravenous catheter assembly of claim 2, wherein the side
port is configured to be connected to one or more lengths of hollow
tubing so that the inside of the hollow tubing is in fluid
communication with the internal fluid passageway.
4. The intravenous catheter assembly of claim 3, further including
hollow tubing connected to the side port, the tubing including a
tube connector configured to be connected to an IV fluid supply
line.
5. The intravenous catheter assembly of claim 1, wherein the septum
has an internal surface defining a slit passing from the first end
to the second end, the slit configured to enable an insertion
needle to pass therethough.
6. The intravenous catheter assembly of claim 1, wherein the septum
has an internal surface defining an aperture passing from the first
end to the second end, the aperture configured to enable an
insertion needle to pass therethough.
7. The intravenous catheter assembly of claim 1, wherein the septum
has an internal surface defining an aperture originating at the
first end and passing through a first thickness, and a slit
originating at the termination of the aperture and passing through
the second end, the aperture and slit together configured to enable
an insertion needle to pass therethough.
8. The intravenous catheter assembly of claim 1, wherein the
catheter hub includes one or more wings extending radially outward
from the catheter hub.
9. The intravenous catheter assembly of claim 8, wherein the wings
are integrally molded onto the catheter hub.
10. The intravenous catheter assembly of claim 8, wherein the wings
are coupled to catheter hub via a collar that at least partially
surrounds the catheter hub.
Description
RELATED APPLICATIONS
[0001] The present application claims the benefit of U.S.
Provisional Application Nos. 62/109,673; 62/109,710; 62/109,715;
62/109,722; 62/109,735; 62/109,742; 62/109,745; 62/109,750;
62/109,755; 62/109,759; 62/109,766, all of which were filed Jan.
30, 2015 and are hereby incorporated herein by reference in their
entirety.
TECHNICAL FIELD
[0002] The present disclosure relates generally to intravenous
catheters, and more particularly to an intravenous catheter
assembly that minimizes the risk of blood exposure to a
clinician.
BACKGROUND
[0003] Intravenous (IV) therapy is a versatile technique used for
the administration of medical fluids to and withdrawal of bodily
fluids from patients. IV therapy has been used for various purposes
such as the maintenance of fluid and electrolyte balance, the
transfusion of blood, the administration of nutritional
supplements, chemotherapy, and the administration of drugs and
medications. Fluids may be administered intravenously by injection
through a hypodermic needle, or intermittently or continuously by
infusion using a needle or catheter. The most common intravenous
access method utilized by clinicians is the peripheral IV
catheter.
[0004] A peripheral IV catheter is made of soft, flexible plastic
or silicone, generally between fourteen to twenty-four gauge in
size. In the conventional venipuncture procedure, a catheter is
inserted into a vein in the patient's hand, foot, or the inner
aspect of the arm or any vein in the body that will accept an IV
catheter. In order to properly place the IV catheter into a
patient's vein, a sharp introducer needle is used to puncture the
skin, tissue, and vein wall to provide a path for placement of the
catheter into the vein.
[0005] Referring to FIGS. 1 and 2, a conventional IV catheter
assembly 20 configured for insertion of an "over-the needle"
catheter 22 is depicted. Catheter 22 generally has a first end 26
for insertion into a biological site, a second end 28 and a
flexible wall defining a lumen extending therebetween. Frequently,
the second end 28 of the catheter 22 is operably coupled to a
catheter hub 34. The catheter 22 is operably coupleable to the
needle assembly 20, in part by positioning the catheter 22
coaxially over a needle 24 of the safety needle assembly 20. The
catheter 22 thus rides with the needle 24 through the skin, tissue,
and vein wall and into the patient's vein. Once the catheter 22 has
entered the patient's vein, the catheter 22 can be advanced further
into the vein as desired and the needle 24 can be withdrawn from
the catheter 22. The catheter 22 can then be secured into place on
the patient and connected to an IV fluid supply line.
[0006] Various catheter insertion devices have been developed to
provide a needle 24 for catheterization. In some cases, a
conventional hollow hypodermic needle 24, such as that depicted in
FIGS. 1 and 2, is used to facilitate catheterization. One such
example of this type catheter insertion device is marketed by
Smiths Medical ASD, Inc. of St. Paul, Minn., under the JELCO
trademark, as described in U.S. Pat. Nos. 7,291,130 and 8,257,322
(depicting an IV catheter insertion device marketed by Smiths
Medical ASD, Inc. under the INTUITIV Safety IV Catheters
trademark), both of which are incorporated by reference herein. In
other cases, the catheter insertion device provides a safety needle
assembly that functions to house the sharpened tip of the needle to
reduce the likelihood of an inadvertent needle stick, Examples of
this type of catheter insertion device are described in U.S. Pat.
No. 5,000,740 (depicting an IV catheter insertion device marketed
by Smiths Medical ASD, Inc. under the PROTECTIV trademark), U.S.
Pat. No. 7,736,342 (depicting an IV catheter insertion device
marketed by Smiths Medical ASD, Inc. under the VIAVALVE trademark),
both of which are incorporated by reference herein,
SUMMARY OF THE DISCLOSURE
[0007] One embodiment of the present disclosure provides an
intravenous catheter assembly including a catheter and a catheter
hub. The catheter has a first end for insertion into a biological
site, a second end and a flexible wall defining a lumen extending
therebetween. The catheter hub has a first catheter hub portion, a
second catheter hub portion, and a septum. The first catheter hub
portion has a first end operably coupled to the second end of the
catheter, a second end, and an internal wall defining a first
internal fluid passageway therebetween. The internal wall of the
first catheter hub portion further defines a side port in fluid
communication with the internal fluid passageway. The second
catheter hub portion has a first end operably coupled to the second
end the first catheter hub portion, a second end, and an internal
wall defining a second internal fluid passageway therebetween. The
second catheter hub portion further has a baffle positioned within
the internal fluid passageway between the first end and the second
end of the second catheter hub portion. The septum is housed within
the first internal fluid passageway of the first catheter hub
portion and is retained in position by the baffle of the second
catheter hub portion.
[0008] In some versions, the first catheter hub portion and the
second catheter hub portion are operably coupled together via a
circumferential tongue and groove assembly. In some versions, the
side port is configured to be connected to one or more lengths of
hollow tubing so that the inside of the hollow tubing is in fluid
communication with the internal fluid passageway. In some versions,
the intravenous catheter assembly further includes hollow tubing
connected to the side port, where the tubing includes a tube
connector configured to be connected to an IV fluid supply line. In
some versions, the septum is self-sealing, such that an insertion
needle can pass therethrough and when withdrawn any void left by
the withdrawn needle will seal to maintain fluid impermeability of
the septum. In some versions, the septum has a first end positioned
proximate to the side port that includes a peripheral chamfered lip
configured to aid in enabling a fluid tight seal with the internal
wall of the first catheter hub portion, in some versions, the
catheter hub includes one or more wings extending radially outward
from the catheter hub. In some versions, the wings are integrally
molded onto the catheter hub. In some versions, the wings are
coupled to the catheter hub via a collar that at least partially
surrounds the catheter hub.
[0009] Another embodiment of the present disclosure provides an
intravenous catheter assembly including a catheter and a catheter
hub. The catheter has a first end for insertion into a biological
site, a second end and a flexible wall defining a lumen extending
therebetween. The catheter hub has a catheter hub body and a
septum. The catheter huh body has a first end operably coupled to
the second end of the catheter, a second end, and an internal wall
defining an internal fluid passageway therebetween. The internal
wall of the catheter hub body further defines a side port in fluid
communication with the internal fluid passageway. The septum is
fixedly coupled within the internal fluid passageway of the
catheter hub body between the second end and the side port. The
septum has a first end positioned proximate to the side port that
includes a peripheral chamfered lip configured to aid in enabling a
fluid tight seal with the internal wall of the first catheter hub
portion.
[0010] In some versions, the side port is configured to be
connected to one or more lengths of hollow tubing so that the
inside of the hollow tubing is in fluid communication with the
internal fluid passageway. In some versions, the intravenous
catheter assembly further includes hollow tubing connected to the
side port, wherein the tubing includes a tube connector configured
to be connected to an IV fluid supply line. In some versions, the
septum is self-sealing, such that an insertion needle can pass
therethrough and when withdrawn any void left by the withdrawn
needle will seal to maintain fluid impermeability of the septum. In
some versions, the catheter hub includes one or more wings
extending radially outward from the catheter hub. In some versions,
the wings are integrally molded onto the catheter hub. In some
versions, the wings are coupled to the catheter hub via a collar
that at least partially surrounds the catheter hub. Another
embodiment of the present disclosure provides an intravenous
catheter assembly including a catheter and a catheter hub. The
catheter has a first end for insertion into a biological site, a
second end and a flexible wall defining a lumen extending
therebetween. The catheter hub has a catheter hub body, a septum,
and a septum retainer. The catheter hub body has a first end
operably coupled to the second end of the catheter hub body, a
second end, and an internal van defining an internal fluid
passageway therebetween. The internal wall of the catheter hub body
further defines a side port in fluid communication with the
internal fluid passageway. The septum is positioned within the
internal fluid passageway bet n the second end of the catheter hub
body and the side port, wherein the septum has a first end
positioned proximate to the side port. The septum retainer is
configured to secure the septum in position within the internal
fluid passageway. The septum retainer has a first end, a second
end, and a wall defining an internal conduit therebetween. The
septum retainer wall further defines one or more apertures in fluid
communication with the internal fluid passageway of the catheter
hub body, wherein the first end of the septum retainer is fixedly
coupled to the first end of the catheter hub body, such that the
lumen of the catheter is in fluid communication with the internal
conduit of the septum retainer. The second end of the septum
retainer includes a flared portion embedded within the septum.
[0011] In some versions, the side port is configured to be
connected to one or more lengths of hollow tubing so that the
inside of the hollow tubing is in fluid communication with the
internal fluid passageway. In some versions, the intravenous
catheter assembly further includes hollow tubing connected to the
side port, wherein the tubing includes a tube connector configured
to be connected to an IV fluid supply line. In some versions, the
septum is self-sealing, such that an insertion needle can pass
therethrough and when withdrawn any void left by the withdrawn
needle will seal to maintain fluid impermeability of the septum. In
some versions, the septum has a first end positioned proximate to
the side port that includes a peripheral chamfered lip configured
to aid in enabling a fluid tight seal with the internal wall of the
first catheter hub portion. In some versions, the catheter hub
includes one or more wings extending radially outward from the
catheter hub. In some versions, the wings are integrally molded
onto the catheter hub. In some versions, the wings are coupled to
the catheter hub via a collar that at least partially surrounds the
catheter hub.
[0012] Another embodiment of the present disclosure provides an
intravenous catheter assembly having a two-way septum valve for
controlling the flow of fluid in a closed system environment to and
from a patient's blood vessel. The intravenous catheter assembly
includes a catheter and a catheter hub. The catheter has a first
end for insertion into a biological site, a second end and a
flexible wall defining a lumen extending therebetween. The catheter
hub has a catheter hub body, a septum, and a septum retainer. The
catheter hub includes a catheter hub body, a two-way septum valve
and a septum retainer. The catheter hub body has a first end
operably coupled to the second end of the catheter, a second end,
and an internal wall defining a first internal fluid passageway
therebetween. The internal wall of the catheter hub body further
defines a transition step within the first internal fluid
passageway between a smaller diameter portion of the first internal
fluid passageway proximal to the first end and a larger diameter
portion of the first internal fluid passageway proximal to the
second end. The two-way septum valve has a first end and a second
end, wherein the two-way septum valve is positioned within the
first internal fluid passageway such that the first end of the
septum abuts up against the transition step. The septum retainer is
at least partially insertable within the first internal fluid
passageway of the catheter hub body and is configured to secure the
two-way septum valve in position within the first internal fluid
passageway. The septum retainer has an outer wall shaped and sized
to interlock with the internal wall of the catheter hub body, and
an internal wall defining a second internal fluid passageway.
[0013] In some versions, when the catheter is inserted into a
patient's blood vessel the first internal fluid passageway is in
uninterrupted fluid communication with the patient's blood vessel
having a venous blood pressure. In some versions, the two-way
septum valve is shiftable between a first open position, a closed
position and a second open position. In the first open position a
first differential pressure between the venous blood pressure and
pressure of fluid contained in the second internal fluid passageway
enables a fluid flow towards the patient's blood vessel. The first
differential pressure is met when the pressure of fluid contained
in the second internal fluid passageway exceeds the venous blood
pressure. In the closed position fluid flow through the fluid
passageway of the two-way septum valve is inhibited. In the second
open position a second differential pressure between the venous
blood pressure and pressure of fluid contained in the second
internal fluid passageway enables a fluid flow away from the
patient's blood vessel. The second differential pressure is met
when the venous blood pressure exceeds the pressure of fluid
contained in the second internal fluid passageway by at least 8.5
inches of water. In some versions, the two-way septum valve is
biased to the closed position.
[0014] In some versions, the second differential pressure is met
when the venous blood pressure exceeds the pressure of fluid
contained in the second internal fluid passageway by at least 22
inches of water. In some versions, the second differential pressure
is met when the venous blood pressure exceeds the pressure of fluid
contained in the second internal fluid passageway by at least 40
inches of water. In some versions, a valve opening of the two-way
septum valve is in the form of at least one slit. In some versions,
the valve opening of the two-way septum valve is in the form of two
crossed slits. In some versions, the two-way septum valve is
substantially dome shaped. In some versions, the peak of the dome
extends towards the first portion of the internal fluid passageway
of the catheter hub. In some versions, the two-way septum valve
includes a circumferential flange operably coupled to the catheter
hub. In some versions, the circumferential flange is coupled to a
central portion of the two-way septum valve by one or more
circumferential living hinges. In some versions, the one or more
circumferential living hinges pivot when the two-way septum valve
shifts to the second open position. In some versions, the two-way
septum valve includes two circumferential living hinges.
[0015] The summary above is not intended to describe each
illustrated embodiment or every implementation of the present
disclosure. The figures and the detailed description that follow
more particularly exemplify these embodiments.
BRIEF DESCRIPTION OF THE DRAWINGS
[0016] The disclosure can be more completely understood in
consideration of the following detailed description of various
embodiments of the disclosure, in connection with the accompanying
drawings, in which:
[0017] FIG. 1 is a perspective view depicting a conventional IV
needle assembly with a catheter positioned over a needle.
[0018] FIG. 2 is a perspective view depicting the conventional IV
needle assembly of FIG. 1 with the catheter removed from the
needle.
[0019] FIG. 3 is a fragmentary exploded sectional view depicting a
first embodiment of an intravenous catheter assembly in accordance
with an embodiment of the disclosure.
[0020] FIG. 4 is a fragmentary sectional view depicting the
intravenous catheter assembly of FIG. 3 in an assembled state.
[0021] FIG. 5 is an exploded perspective view depicting a catheter
hub in accordance with an embodiment of the disclosure.
[0022] FIG. 6 is a fragmentary cross sectional view depicting an
intravenous catheter assembly operably coupled to a catheter
insertion device in accordance with a second embodiment of the
disclosure.
[0023] FIG. 7 is a fragmentary cross sectional view depicting the
intravenous catheter assembly of FIG. 6.
[0024] FIG. 8 is a perspective view depicting the intravenous
catheter assembly of FIG. 7, including views of internal parts.
[0025] FIG. 9A is a fragmentary cross sectional view depicting an
intravenous catheter assembly with a two-way septum valve operably
coupled to a catheter insertion device in accordance with an
embodiment of the disclosure.
[0026] FIG. 9B is a fragmentary cross sectional view depicting the
intravenous catheter assembly of FIG. 9A, with the two-way septum
valve in a first open position.
[0027] FIG. 9C is a fragmentary cross sectional view depicting the
intravenous catheter assembly of FIG. 9A, with the two-way septum
valve in a closed position.
[0028] FIG. 9D is a fragmentary cross sectional view depicting the
intravenous catheter assembly of FIG. 9A, with the two-way septum
valve in a second open position.
[0029] FIG. 10 is a cross sectional view depicting a two-way septum
valve in place in an overmolded ring in accordance with an
embodiment of the disclosure.
[0030] FIG. 11 is a perspective view depicting a two-way septum
valve in accordance with an embodiment of the disclosure.
[0031] FIG. 12 is a perspective view depicting an intravenous
catheter assembly including tubing, a clamp and a tube connector in
accordance with an embodiment of the disclosure.
[0032] FIG. 13A is a fragmentary side view depicting a tube
connector coupled with tubing in accordance with an embodiment of
the disclosure.
[0033] FIG. 13B is a cross sectional view depicting the tube
connector of FIG. 143 in a closed configuration.
[0034] FIG. 13C is a fragmentary cross sectional view depicting the
tube connector of FIG. 13A in an open configuration, in conjunction
with an IV fluid supply line.
[0035] FIG. 14A is an exploded side view depicting a first catheter
insertion device for use with an intravenous catheter assembly (not
shown) in accordance with an embodiment of the disclosure.
[0036] FIG. 14B is an exploded top view depicting the first
catheter insertion device of FIG. 14A.
[0037] FIG. 15 is a perspective view depicting a first catheter
insertion device operably coupled to an intravenous catheter
assembly in accordance with an embodiment of the disclosure.
[0038] FIG. 16A is a perspective view depicting a first catheter
insertion device and an intravenous catheter assembly in accordance
with an embodiment of the disclosure, wherein the first catheter
insertion device and intravenous catheter assembly are separated
from one another.
[0039] FIG. 16B is a perspective view depicting the first catheter
insertion device and the intravenous catheter of FIG. 16A, wherein
the first catheter insertion device and intravenous catheter
assembly are operably coupled to one another.
[0040] FIG. 17A is a top perspective view depicting a second
catheter insertion device and an intravenous catheter assembly in
accordance with an embodiment of the disclosure, wherein the second
catheter insertion device is in a first position.
[0041] FIG. 17B is a top perspective view depicting the second
catheter insertion device and the intravenous catheter assembly of
FIG. 17A, wherein the second catheter insertion device is in a
second position and separated from the intravenous catheter.
[0042] FIG. 18A is a bottom perspective view depicting a second
catheter insertion device and an intravenous catheter assembly in
accordance with an embodiment of the disclosure, wherein the second
catheter insertion device is in a first position.
[0043] FIG. 18B is a bottom perspective view depicting the second
catheter insertion device and the intravenous catheter of FIG. 18A,
wherein the second catheter insertion device is in a second
position.
[0044] FIG. 19 is a perspective view depicting a third catheter
insertion device operably coupled to an intravenous catheter
assembly in accordance with an embodiment of the disclosure.
[0045] FIG. 20A is a perspective view depicting a catheter
insertion device and an intravenous catheter assembly in accordance
with an embodiment of the disclosure, wherein the catheter
insertion device is in a first position.
[0046] FIG. 20B is a perspective view depicting the catheter
insertion device and the intravenous catheter assembly of FIG. 20A,
wherein a cap of the third catheter insertion device has been
removed.
[0047] FIG. 20C is a perspective view depicting the catheter
insertion device and the intravenous catheter assembly of FIG. 20A,
wherein the third catheter insertion device is in a second
position, with the needle housing separated from the catheter hub
304.
[0048] While embodiments of the disclosure are amenable to various
modifications and alternative forms, specifics thereof shown by way
of example in the drawings and will be described in detail. It
should be understood, however, that the intention is not to limit
the disclosure to the particular embodiments described. On the
contrary, the intention is to cover all modifications, equivalents,
and alternatives falling within the spirit and scope of the
disclosure as defined by the appended claims.
DETAILED DESCRIPTION
[0049] Referring to FIGS. 1 and 2, a conventional IV catheter
assembly 20 is depicted. Details of the conventional IV catheter
assembly 20 are described in the Background section above.
First Embodiment
[0050] Referring to FIGS. 3-5, an intravenous catheter assembly 100
according to a first embodiment of the disclosure is depicted.
Intravenous catheter assembly 100 generally includes a catheter 102
and a catheter hub 104. Catheter hub 104 can be comprised of a
first catheter hub portion 104A, a second catheter hub portion
104B, and a valve and/or septum 114,
[0051] First catheter hub portion 104A can have a first end 118, a
second end 120, and an internal wall 117 defining a first internal
fluid passageway 116 therebetween. In one version, the internal
wall 117 further defines a side port 122. In other versions, the
intravenous catheter assembly 100 does not include a side port. In
one version, the first end 118 is operably coupled to the second
end 112 of the catheter 102. For example, a portion 112 of catheter
102 can extend into and overlap with first catheter hub portion
104A so that the catheter lumen 108 is in fluid communication with
the first internal fluid passageway 116.
[0052] In one version, the side port 122 is in fluid communication
with first internal fluid passageway 116. In one version, the side
port 122 extends away from the first internal fluid passageway 116
at an oblique angle to the catheter lumen 108. Side port 122 can
provide a connection point to one or more lengths of a tubing 544
(as depicted for example in FIG. 12), so that the inside of the
tubing 544 is in fluid communication with the internal fluid
passageway 116.
[0053] The second catheter hub portion 104B can have a first end
128 operably coupled to the second end 120 the first catheter hub
portion 104A, a second end 130, and an internal wall 131 defining a
second internal fluid passageway 126 therebetween. In one version,
the second end 120 of first catheter hub portion 104A and the first
end 128 of the second catheter hub portion 104B can each define a
respective first and second portion of a coupling 124A/B, such that
second portion 124B is configured to selectively couple with first
portion 124A. For example, in one version, each portion of the
coupling 124 is configured with a circumferential tongue, a
circumferential groove, or both a tongue and a groove to lock one
portion of the coupling with the other portion. In other versions,
respective portions of coupling can be friction fit, screwed,
ultrasonically welded, adhered, or otherwise pieced together to
complete coupling 124. In this manner, first catheter hub portion
104A can be locked together with second catheter hub portion 104B
during assembly.
[0054] In one version, the second catheter hub portion 104B further
has a baffle 132 positioned within the second internal fluid
passageway 126 between the first end 128 and the second end 130 of
the second catheter hub portion 104B. In one version, the baffle
132 can include an aperture 134 sized to enable a needle to pass
there through.
[0055] Septum 114 can have a first end 136, a second end 138 and an
outer perimeter 140. In one version, the septum 114 is constructed
of a flexible, fluid impermeable material. For example, in one
version, septum 114 is constructed of silicon. In one version, the
septum 114 is self-sealing, so that when a needle is withdrawn
through septum 114, any void left by the withdrawn needle will
close and the septum 114 will maintain its fluid
impermeability.
[0056] In one version, the septum 114 is positioned partially
within the first internal fluid passageway 116 of first catheter
hub portion 104A, at least partially within the second end 120.
Septum 114 can be constrained about its perimeter by internal wall
117 of first catheter hub portion 104A. That is, septum 114 is
sized to be received within the first internal fluid passageway 116
to create a fluid tight seal with internal wall 117 to guard
against fluid within the lumen 108 or first internal fluid
passageway 116 from escaping through the second end 120 of first
catheter hub portion 104A. In one version, septum 114 is adhered to
the internal wall 117 of first internal fluid passageway 116, so as
to constrain septum 114 axially and facilitate a radial fluid tight
seal with internal wall 117. Septum 114 is constrained on its
second end 138 by baffle 132. Accordingly, in one version, the
septum 114 is positioned within the first internal fluid passageway
116 and constrained by the coupling of first catheter hub portion
104A to second catheter hub portion 104B. In another version, a
feature such as a groove, step or baffle in the first catheter hub
portion 104A can constrain septum 114.
[0057] In one version, the first end 136 of septum 114 includes a
peripheral chamfered lip 142. Peripheral chamfered lip 142 is
configured to aid in enabling a fluid tight seal with internal wall
117. In particular, the flexibility of septum 114 and the structure
of peripheral chamfered lip 142 enable this portion of the septum
114 to deform under the internal fluid pressure of first internal
fluid passageway 116 to further aid in the creation of a fluid
tight seal with internal wall 117. In one version, the second end
138 of septum is also chamfered to aid in construction by reducing
the possibility that excess septum material will get caught in the
coupling 124 when first catheter hub portion 104A is mated with
second catheter hub portion 104B. In other versions, peripheral
chamfered lip 142 can be filleted, or there can be no lip at
all.
Second Embodiment
[0058] Referring to FIGS. 6-8, an intravenous catheter assembly 200
according to a second embodiment of the disclosure is depicted.
Intravenous catheter assembly 200 generally includes a catheter 202
and a catheter hub 204. Catheter hub 204 can be comprised of a
catheter hub body 205, a valve and/or septum 214, and a valve
and/or septum retainer 215.
[0059] Catheter hub body 205 can have a first end 218, a second end
220, and an internal wall 217 defining a first internal fluid
passageway 216 therebetween. In one version, the internal wall 217
further defines a side port 222. In other versions, the intravenous
catheter assembly 200 does not include a side port. In one version,
the first end 218 is operably coupled to the second end 212 of the
catheter 202. For example, a portion of catheter 202 can extend
into and overlap with catheter hub body 205 so that the catheter
lumen 208 is in fluid communication with the internal fluid
passageway 216.
[0060] In one version, the side port 222 is in fluid communication
with first internal fluid passageway 216. In one version, the side
port 222 extends away from the first internal fluid passageway 216
at an oblique angle to the catheter lumen 208. Side port 222 can
provide a connection point to one or more lengths of a tubing 544
(as depicted for example in FIG. 12), so that the inside of the
tubing 544 is in fluid communication with the internal fluid
passageway 216.
[0061] Septum 214 can have a first end 236, a second end 238 and an
outer perimeter 240. In one version, the septum 214 is constructed
of a flexible, fluid impermeable material. For example, in one
version, septum 214 is constructed of silicone, polyisopren, or the
like. In one version, the septum 214 is self-sealing, so that when
a needle 160 is withdrawn through septum 214, any void left by the
withdrawn needle will close and the septum 214 will maintain its
fluid impermeability.
[0062] In one version, the first end 236 of septum 214 includes a
peripheral chamfered lip 242. Peripheral chamfered lip 242 is
configured to aid in enabling a fluid tight seal with internal wall
217. In particular, the flexibility of septum 214 and the structure
of peripheral chamfered lip 242 enable this portion of the septum
214 to deform under the internal fluid pressure of first internal
fluid passageway 216 to further aid in the creation of a fluid
tight seal with internal wall 217. In other versions, peripheral
chamfered lip 242 can be filleted, or there can be no lip at
all.
[0063] In one version, the septum 214 is positioned partially
within the internal fluid passageway 216 proximal to side port 222.
Septum 214 can be constrained about its outer perimeter 240 by
internal wall 217 of catheter hub body 205. In particular, in one
version, the septum 214 is sized to be within the first internal
fluid passageway 216 to create a fluid tight seal with internal
wall 217 to inhibit fluid within the lumen 208 or first internal
fluid passageway 216 from escaping through the second end 220 of
catheter hub 204. Septum 214 can be axially constrained by septum
retainer 215. As shown, an outer diameter of the outer perimeter
240 of the septum may be out of contact with the internal wall 217
or in contact but at a lower pressure level than portions of the
septum 214 proximal to the second end 238. This may reduce the
axial pressure on the needle in order to reduce needle withdrawal
forces.
[0064] Septum retainer 215 can be configured to secure the septum
214 in position within the internal fluid passageway 216. In one
version, the septum retainer 215 has a first end 219, a second end
221, and a wall 224 defining an internal conduit 227 therebetween.
Internal conduit 227 can be in fluid communication with catheter
lumen 108. In one version, the wall 224 can further define one or
more apertures 223 in fluid communication with the internal fluid
passageway 216 of the catheter hub body 205, thereby enabling fluid
to flow pass through lumen 208, through one or more apertures 223,
and into internal fluid passageway 216.
[0065] In one version, the first end 219 of the septum retainer 215
is operably coupled to the first end 218 of the catheter huh body
205, such that the lumen 208 of the catheter 202 is in fluid
communication with the internal conduit 227 of the septum retainer
215. In one version, the internal conduit 227 can be tapered so
that the diameter of the portion of internal conduit 227 proximate
to the connection to catheter 202 is approximately equal to the
diameter of the lumen 208. In one version, the first end 219 of
septum retainer 215 is press fit into catheter huh 204. In other
versions, septum retainer 215 is fixedly coupled to catheter hub
204 by adhesive, ultrasonic welding, or another method.
[0066] In one version, the second end 221 of the septum retainer
215 can include a flared portion 225 embedded within the septum
214, so that septum 214 is fixedly coupled to catheter hub body 205
by septum retainer 215.
[0067] Septums and Valves
[0068] As depicted in FIGS. 3-8, the septum 114, 214 can include a
peripheral chamfered lip configured to aid in enabling a fluid
tight seal with internal wall. It is to be appreciated, however,
that the septum 114, 214 can have other configurations.
[0069] Referring to FIGS. 9A-11, in some versions, catheter hub 104
and 204 (or other types of catheter hubs) can include a two-way
septum valve 387.
[0070] In some versions, a two-way septum valve 387 can have a
first end 388 and a second end 389, wherein the two-way septum
valve 387 is positioned within the first internal fluid passageway
316 such that the first end 388 of the two-way septum valve 387
abuts up against the transition step 307. In some versions, septum
retainer 315 is at least partially insertable within the first
internal fluid passageway 316 of the catheter hub body 305 and is
configured to secure the two-way septum valve 387 in position
within the first internal fluid passageway 316. For example, the
septum retainer 315 can have an outer wall 324 shaped and sized to
interlock with the internal wall 317 of the catheter hub body 305.
The septum retainer 315 can also have an internal wall 323 defining
a second internal fluid passageway 326.
[0071] The two-way septum valve 387 can be positioned between the
first internal fluid passageway 316 and the second internal fluid
passageway 326, and can be configured to control the flow of fluid
between the two internal fluid passageways. When the catheter 302
is inserted into a patient's blood vessel the first internal fluid
passageway 316 is in uninterrupted fluid communication with the
patient's blood vessel, wherein the patient's blood vessel has a
venous blood pressure.
[0072] In one version, the two-way septum valve 387 is biased to a
closed position, in which the flow of fluid between the first
internal fluid passageway 316 and the second internal fluid
passageway 326 is inhibited, but is configured to enable a needle
160 of a catheter insertion device to pass therethrough (as
depicted in FIG. 9A). The two-way septum valve 387 can additionally
be configured to shift between various open and closed positions
based on the differential pressure between the first internal fluid
passageway 316 and the second internal fluid passageway 326. For
example, in one version, the two-way septum valve 387 is shiftable
between a first open position (as depicted in FIG. 9B), a closed
position (as depicted in FIG. 9C) and a second open position (as
depicted in FIG. 9D).
[0073] In the first open position, a first differential pressure
between the venous blood pressure and pressure of fluid contained
in the second internal fluid passageway 326 enables a fluid flow
towards the patient's blood vessel. For example, the first
differential pressure is met when the pressure of fluid contained
in the second internal fluid passageway 326 exceeds the venous
blood pressure. In the closed position, fluid flow through the
fluid passageway of the two-way septum valve is inhibited. In the
second open position, a second differential pressure between the
venous blood pressure and pressure of fluid contained in the second
internal fluid passageway 326 enables a fluid flow away from the
patient's blood vessel. For example, the second differential
pressure is met when the venous blood pressure exceeds the pressure
of fluid contained in the second internal fluid passageway by at
least 8.5 inches of water. In some versions, the second
differential pressure is met when the venous blood pressure exceeds
the pressure of fluid contained in the second internal fluid
passageway 326 by at least 22 inches of water or at least 40 inches
of water.
[0074] Referring to FIG. 10, a cross-sectional view of an example
embodiment of two-way septum valve 387 is depicted. Two-way septum
valve 387 can be fixed to an overmolded plastic ring 390.
Overmolded plastic ring 390 generally includes a cylindrical
portion 391 and a valve engaging portion 392. When the two-way
septum valve 387 is supported in the overmolded plastic ring 390,
the overall diameter of the two-way septum valve 387 is reduced,
thus more readily permitting accommodation within catheter hub 104
and 204.
[0075] Referring to FIG. 11, the shape of two-way septum valve 387
is depicted as being generally circular; this, however, should not
be considered limiting, as other shapes can be used according to
the disclosure. In one version, the two-way septum valve 387 is a
unitary structure, having a central portion 393, a circumferential
flange 394, a flexible membrane 395 having one or more valve
openings 396, and one or more circumferential living hinges 397. In
one version, there are two circumferential living hinges 379A and
379B. First living hinge 379A is located between circumferential
flange 394 and support. Second living hinge 379B is located on the
central portion 393 between support and flexible membrane 395.
[0076] As discussed herein, two-way septum valve 387 has a
differential pressure response in that the pressure required to
open two-way septum valve 387 in a first direction (enabling fluid
flow towards the patient's blood vessel) is substantially less than
the pressure required to open two-way septum valve 387 in the
second direction (enabling fluid flow from the patient's blood
vessel). Accordingly, two-way septum valve 387 inhibits leakage of
fluid under normal blood pressure while permitting IV fluid to
flow, as well as enabling the aspiration of blood through two-way
septum valve 387 either by application of a reduced or negative
pressure of fluid contained in the second internal fluid passageway
326, or the or by insertion of a needle through valve opening
396.
[0077] In one version, the central portion 393 is substantially
dome shaped having a dome peak 399. In one version, the one or more
valve openings 396 are in the form of at least one of an aperture,
a single slit, a tri-slit, and a cross slit. In one version, the
dome shaped central portion 393 has an opening pressure in the
first direction of about 15 mm of mercury which is equivalent to
0.3 pounds per square inch, and an aspiration pressure in the
second direction of approximately 300 mm mercury or about 6 pounds
per square inch. In one version, the two-way septum valve 387 has
an infusion flow rate at 40 inches of water pressure in the first
direction of approximately 4,500 ml/hour (75 ml/min).
[0078] Universal Wings
[0079] Referring to FIG. 12, in some versions, catheter hub 104,
204 and 304 can include one or more wings 484 that extend radially
from catheter hub 304. In one version, the one or more wings 484
generally extend outwardly from the central axis of the catheter
302 and catheter hub 304, so as to provide an adequate gripping
surface for a user or clinician, as well as an extended surface for
aid in securing catheter hub 304 in place on the patient. In one
version, the one or more wings 484 are integrally molded onto a
portion of catheter hub 304.
[0080] Universal Tubing, Clamp and Tube Connector
[0081] Referring to FIGS. 12-13C, in some versions, intravenous
catheter assembly 100, 200 and 300 include at least one of a hollow
tubing extension 544, a tubing clamp 546 and a tube connector 548.
In one version, the hollow tubing 544 can be substantially
transparent or translucent to enable the observation of fluid
within the hollow tubing 544. In one version, the tube clamp 546 is
constructed of a resilient material that can be deformed to
selectively occlude hollow tubing 544 to restrict the passage of
fluid.
[0082] Tube connector 548 is configured to connect hollow tubing
544 to an fluid supply line 558. In one version, the tube connector
548 is a luer lock. In another version, tube connector 548 is a
needle-free connector, for example the connector described in U.S.
Pat. No. 7,713,248 (depicting a needle-free connect, marketed by
ICU Medical, Inc. under the Clave.RTM. trademark), which is hereby
incorporated by reference. In one version, the tube connector 548
is comprised of a conical internal conduit 550 with one or more
fluid path windows 552, a flexible compression seal 554 capable of
selectively covering the conduit 550, and a housing 556
substantially surrounding conduit 550 and compression seal 554.
Tube connector 548 can guard against contamination of the fluid
path. As depicted in FIG. 13B, when compression seal 554 is in its
uncompressed state it extends over the fluid path window 552 of
conduit :550, thereby creating a fluid seal to restrict fluid from
escaping from tubing 544. Conversely, as depicted in 13C, when a
portion of an fluid supply line 558, such as a portion of a luer
connector, is inserted into housing 556, compression seal 545 is
shifted to a compressed state, thereby exposing the fluid path
windows 552 to the fluid path of the IV fluid supply line 558. In
one version, the tube connector 548 further includes a venting
adapter (not shown) to vent trapped gas from tubing 544. Venting
adapter can be comprised of a material that enables air to vent as
blood or fluid fills the tubing 544, but inhibits the fluid from
passing through the tube connector 548.
[0083] Connection to Various Catheter Insertion Devices
[0084] Referring to FIGS. 14A-20C in some versions, the second end
130 of second catheter tub portion 104B, or the second end 220 and
320 of catheter hub bodies 205 and 305 can be configured to receive
a portion of a catheter insertion device 600, 700 and 800. In some
versions, second end 130, 220 is tapered to create a friction fit
with needle insertion device 600, 700 and 800, thereby selectively
coupling catheter hub 104, 204 and 304 to needle insertion device
600, 700 and 800.
[0085] First Catheter Insertion Device
[0086] Referring to FIGS. 14A-16B, in some versions, catheter
insertion device 600 generally includes needle 660 and needle hub
662. Needle 660 can be a thin walled hollow tube, defining a lumen
663 along its central axis, with a first end 664 and a second end
666. First end 664 can be defined by a sharpened tip 668 to reduce
the insertion force required to penetrate the skin of a patient.
Second end 666 can be fixedly coupled to needle hub 662.
[0087] In one version, needle hub 662 has a first end 670 and a
second end 672. First end 674 of needle hub 662 can be configured
with a tapered blunt tip sized to create a friction fit with a
portion of catheter hub 304. In one version, the needle hub 662
includes a flash chamber 674.
[0088] Flash chamber 674 can be configured as a cavity in fluid
communication with the lumen 663 of hypodermic needle 660 opposite
sharpened tip 668. Flash chamber 670 functions in cooperation with
other elements of the catheter insertion device 600 so that blood
from the user visibly flows into the flash chamber 674 to
positively indicate when the needle 660 has pierced a vein. In one
version, the flash chamber 674 can be constructed of a transparent
or translucent material to enable a clinician to visually see when
fluid enters the flash chamber 674. The rear 676 of flash chamber
674 can be plugged with a microporous flash plug 678. Flash plug
678 can be comprised of a material that enables air to vent from
the flash chamber 674 as fluid fills the chamber, but inhibit the
fluid from passing from the flash chamber 674. In other versions,
plug 678 can be non-microporous.
[0089] In some versions, flash chamber 674 can further include a
diagnostic sampling port configured to enable selective access to
fluid contained within flash chamber 674. Various needle assemblies
having diagnostic sampling ports are disclosed in a concurrently
filed application entitled "Needle Assembly with Diagnostic
Analysis Provisions," Attorney Docket No. 4176.178US02, which is
incorporated by reference herein.
[0090] In one version, needle hub 662 can include at least one wing
680 that extends outwardly from the needle hub 662. In one version,
the wing 680 is generally longitudinally aligned with the central
axis of the needle 660. Wing 680 can be configured with sufficient
surface area to enable a user or clinician to easily grasp and
maneuver the catheter insertion device 600, while providing the
user or clinician an unobstructed view of the flash chamber 674
during catheterization. In one version, the wider grip portion 682
of wing 680 can be provided for this purpose. In one version, for
better control of the catheter assembly, wing 680 can extend
forward of the first end 670 of needle hub 662 to overlap with the
needle 660. In one version, the wing 680 and the rest of needle hub
662 are integrally formed of a plastic material. In another
version, wing 680 is formed as an extension of flash plug 678.
[0091] Second Catheter Insertion Device
[0092] Referring to FIGS. 12 and 17A-18B, in some versions,
catheter insertion device 700 generally includes needle housing 718
and needle hub 720 coupled to needle 760. Needle housing 718 has a
first end 724 and a second end 726. First end 724 of needle housing
718 can be configured with a tapered blunt tip sized to create a
friction fit with a portion of catheter hub 104, 204 and 304. In
some versions, first end 724 can be at least partially inserted
into a socket defined in catheter hub 104, 204 and 304. First end
724 can further define an aperture 728 through which needle 760 can
pass.
[0093] Needle hub 720, which in some versions can be fixedly
coupled to the needle 760, can be slideably coupled to the needle
housing 718. For example, in one version, the needle hub 720 can
have a "C" shaped cross section 730 conformed to fit around the
outer surface of the needle housing 718 in a manner that inhibits
the needle hub 720 from readily separating from the needle housing
718, yet enables the needle hub 720 to slide along the longitudinal
axis of the needle housing 718 with minimal resistance. In a
further version, the needle hub 720 can be configured to slide
along a groove 734 defined in the needle housing 718 to restrict
the needle hub 720 from rotating about the longitudinal axis of the
needle housing 718. In one version, the needle hub 720 can include
a protuberance 736 (as depicted in FIGS. 18A-B) configured to fit
within the groove 734 of the needle housing 718, thereby enabling
linear movement of the needle hub 720 substantially parallel to the
longitudinal axis of the needle housing 718, but restricting the
rotational movement of the needle hub 720 relative to the needle
housing 718.
[0094] In one version, the needle hub 720 is slideable between a
first position (as depicted in FIGS. 17A and 18A) and a second
position (as depicted in FIGS. 17B and 18B). In the first position,
a portion of the needle 760 extends through needle housing aperture
728, the catheter hub 304 and catheter lumen 308, such that the
sharpened tip 768 of the needle 760 protrudes slightly beyond first
end 310 of catheter 302. In the second position, the needle 760 is
withdrawn from the catheter lumen 308 and the catheter hub 304 and
the sharpened tip 768 is sheathed by needle housing 718 in a manner
intended to reduce or eliminate the likelihood of an inadvertent
needle stick. In some versions, catheter insertion device 700 can
include a catheter hub coupling and release mechanism configured to
couple to catheter hub 104, 204, or 304 in the first position, and
release from catheter hub 104, 204, 304 in the second position.
Various catheter hub coupling and release mechanism are disclosed
in a concurrently filed application entitled "Releaseable Catheter
Hub Retainer," Attorney Docket No. 4176.180US02, which is
incorporated by reference herein.
[0095] In one version, the needle 760 can be locked in position
relative to the needle housing 718. Several different types of
locking mechanisms can be used for this purpose. For example, in
one version, the groove 734 of the needle housing 718 can have a
bottleneck 738 defined in it, where the bottleneck 738 portion of
groove 734 generally has a narrower width than the rest of groove
734. Protuberance 736 of needle hub 720 can be triangular or
wedge-like in shape (as depicted in FIGS. 18A-B) where the apex of
the wedge faces the bottleneck 738 when in the first position. When
an external force is applied to the needle hub 720 in an effort to
slide it into the second position, the apex of the wedge of the
protuberance 736 comes into contact with the bottleneck 738.
Bottleneck 738, which can have a width narrower than that of the
protuberance 736 will initially resist movement of the protuberance
736 through the bottleneck 738. However, with sufficient force the
wedge-shape protuberance 736 will cause the bottleneck 738 to
temporarily deform, thereby enabling the protuberance 736 to pass
through the bottleneck 738. Thereafter the protuberance 736 will be
unable to pass back through the bottleneck 738 in the opposite
direction, and the needle 760 will be locked in position relative
to the needle housing 718.
[0096] In one version, the movable element 720 further includes a
flash chamber 774. Flash chamber 774 can be configured as a cavity
in fluid communication with the lumen of hypodermic needle 760
opposite sharpened tip 768. In one version, the flash chamber 774
can be constructed of a transparent or translucent material to
enable a clinician to visually see when fluid enters flash chamber
774. The rear 726 of flash chamber 774 can be plugged with a
microporous flash plug 778. Flash plug 778 can be comprised of a
material that enables air to vent from the flash chamber 774 as
fluid fills the chamber, but inhibits the fluid from passing from
the flash chamber 774.
[0097] Third Catheter Insertion Device
[0098] Referring to FIGS. 19-20C, in some versions, catheter
insertion device 800 further includes cap 880. Cap 880 is
configured to cover a portion of the needle housing 818 proximate
to the second end 826 to reduce the likelihood of unwanted or
uncontrolled movement of the needle housing 818 relative to the
needle hub 820 by the user or clinician's palm or inside of their
hand during catheter insertion.
[0099] In one version, the cap 880 is tubular in shape and has a
first end 882 and a second end 884. In one version, the cap 880
tapers slightly from the first end 882 to the second end 884.
Second end 884 can include a wall 886 extending radially inward to
effectively close off the second end 884. In one version, the wall
886 can include an aperture 888 for venting of the interior of the
cap 880.
[0100] First end 882 can be coupled to he needle hub 820, so as to
move along with the needle hub 820 and cover a portion of the
needle housing 818. In one version, the needle hub 820 includes an
arcuate rib 890, and the cap 880 includes a recess or groove 892
sized to receive the rib 890, so that the cap 880 can be coupled to
the moveable element 820 by joining the rib 890 to the groove 892.
In other versions, the cap 880 and the needle hub 820 can be
attached by adhesive, ultrasonic bonding, or any other method.
[0101] In one version, the needle 860 includes a notch 894 defined
proximate to the sharpened tip 868. Notch 894 can be in fluid
communication with the needle lumen 863. In one version, the
catheter 302 is constructed of a transparent or translucent
material, so that blood or other body fluid can be visible in the
notch 894 when the needle 860 has pierced a vein.
[0102] In some versions, catheter insertion device 600, 700, and
800 can include at least one of a protective needle sheath, a
self-contained antiseptic swab, and a tourniquet for treatment
and/or preparation of a biological site of a patient. Various
catheter insertion devices having protective needle sheaths, a
self-contained antiseptic swabs, and/or tourniquets are disclosed
in a concurrently filed application entitled "Antiseptic Sheath
with Site Preparation Provisions," Attorney Docket No.
4176.179US02, which is incorporated by reference herein.
[0103] Operation of the Intravenous Catheter Assembly
[0104] In operation, placement of intravenous catheter assembly
100, 200, or 300 generally includes preparation of the biological
site of the patient. Often a tourniquet is applied proximal to the
biological site and a variety of techniques can be used to dilate
the patient's vein. While wearing disposable gloves, the clinician
cleanses the biological site and a vein is retracted or anchored by
placing a thumb over the vein about fifty to seventy-five mm distal
to the site. The needle 760 for instance and catheter 302 for
instance are introduced into the vein by inserting the bevel of the
sharpened tip 768 into the vein at about a twenty to thirty degree
angle with the bevel facing up in order to pierce one wall of the
vein. In some versions, during this process the clinician grips the
needle hub 720 for optimum control.
[0105] If successful, blood from the vein will flow through the
lumen of the needle 760 and into the flashback chamber 774, thereby
indicating that the vein has been entered. To finish placement, the
safety catheter assembly 600, 700 or 800 is lowered towards the
skin to decrease the entry angle, and the catheter 302 is advanced
slightly into the vein. The needle 760 is loosened and the catheter
302 is gently advanced farther up into the vein until the catheter
hub 304 is against the biological site.
[0106] The tourniquet is loosened and the needle 760 is withdrawn
from the catheter 302. As needle 760 is withdrawn, the sharpened
tip 768 is withdrawn through catheter lumen 308, internal fluid
passageway 316 and valve or septum 314. As the sharpened tip 768
passes through the valve or septum 314, the self-sealing nature of
the valve or septum 314 closes any void left by the needle to
create a fluid tight barrier.
[0107] The catheter hub 304 can be secured to the biological site
by gauze and adhesive tape. In some versions, the added surface
area of the catheter hub wings 484 is used when securing the
catheter 302 to the biological site. The various versions of the
disclosure enable an IV fluid supply line 558 to be connected prior
to catheterization. Once the catheter assembly 100, 200 or 300 is
in place, clamp 546 can be manipulated as desired to open or close
the fluid path to IV fluid supply line 558.
[0108] Persons of ordinary skill in the relevant arts will
recognize that embodiments may comprise fewer features than
illustrated in any individual embodiment described above. The
embodiments described herein are not meant to be an exhaustive
presentation of the ways in which the various features may be
combined. Accordingly, the embodiments are not mutually exclusive
combinations of features; rather, embodiments can comprise a
combination of different individual features selected from
different individual embodiments, as understood by persons of
ordinary skill in the art. Moreover, elements described with
respect to one embodiment can be implemented in other embodiments
even when not described in such embodiments unless otherwise noted.
Although a dependent claim may refer in the claims to a specific
combination with one or more other claims, other embodiments can
also include a combination of the dependent claim with the subject
matter of each other dependent claim or a combination of one or
more features with other dependent or independent claims. Such
combinations are proposed herein unless it is stated that a
specific combination is not intended. Furthermore, it is intended
also to include features of a claim in any other independent claim
even if this claim is not directly made dependent to the
independent claim.
[0109] Any incorporation by reference of documents above is limited
such that no subject matter is incorporated that is contrary to the
explicit disclosure herein. Any incorporation by reference of
documents above is further limited such that no claims included in
the documents are incorporated by reference herein. Any
incorporation by reference of documents above is yet further
limited such that any definitions provided in the documents are not
incorporated by reference herein unless expressly included
herein.
[0110] For purposes of interpreting the claims, it is expressly
intended that the provisions of Section 112, sixth paragraph of 35
U.S.C. are not to be invoked unless the specific terms "means for"
or "step for" are recited in a claim.
* * * * *