U.S. patent application number 10/256608 was filed with the patent office on 2003-04-03 for catheter having a wing with a stiffening member therein.
Invention is credited to Brimhall, Greg L., Thoresen, Stephen Lynn.
Application Number | 20030065288 10/256608 |
Document ID | / |
Family ID | 25345167 |
Filed Date | 2003-04-03 |
United States Patent
Application |
20030065288 |
Kind Code |
A1 |
Brimhall, Greg L. ; et
al. |
April 3, 2003 |
Catheter having a wing with a stiffening member therein
Abstract
A catheter assembly is disclosed having wings extending from the
catheter adapter wherein each of the wings includes a stiffening
member located therein. Each of the stiffening members may also
define a means for maintaining the position of the stiffening
members during the molding process to ensure that the stiffening
member is properly located in the wing.
Inventors: |
Brimhall, Greg L.; (West
Jordan, UT) ; Thoresen, Stephen Lynn; (Orem,
UT) |
Correspondence
Address: |
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes
NJ
07417-1880
US
|
Family ID: |
25345167 |
Appl. No.: |
10/256608 |
Filed: |
September 27, 2002 |
Related U.S. Patent Documents
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
|
|
10256608 |
Sep 27, 2002 |
|
|
|
09865297 |
May 25, 2001 |
|
|
|
Current U.S.
Class: |
604/165.03 ;
604/177 |
Current CPC
Class: |
A61M 25/02 20130101;
A61M 25/0009 20130101; A61M 2025/0286 20130101; A61M 25/0631
20130101; A61M 25/0637 20130101 |
Class at
Publication: |
604/165.03 ;
604/177 |
International
Class: |
A61M 005/178 |
Claims
We claim:
1. A catheter assembly, comprising: a catheter; and a catheter
adapter defining a main body portion and having at least one wing
extending therefrom and a stiffening member disposed in the
wing.
2. The catheter assembly of claim 1 wherein the at least one wing
defines a suture hole extending therethrough.
3. The catheter assembly of claim 2 wherein the suture hole extends
through the stiffening member.
4. The catheter assembly of claim 3 wherein the suture hole extends
through an end portion of the stiffening member that is remote from
the main body portion of the catheter adapter.
5. The catheter assembly of claim 1 wherein the stiffening member
is formed from a first material and the wing is formed from a
second material.
6. The catheter assembly of claim 5 wherein the first material is
more rigid than the second material.
7. The catheter assembly of claim 1 wherein a first support extends
upwardly from the stiffening member.
8. The catheter assembly of claim 7 wherein a second support
extends downwardly from the stiffening member.
9. A method of forming a catheter adapter, comprising: molding a
catheter adapter having at least one stiffening member extending
therefrom wherein the stiffening member defines a means thereon for
maintaining the position of the stiffening member; and molding a
wing over the stiffening member.
10. The method of claim 9 wherein a first material is used to mold
the catheter adapter and the at least one stiffening member and a
second material is used to mold the wing.
11. The method of claim 10 wherein the first material is more rigid
than the second material.
12. The method of claim 9 wherein the wing is molded over the
stiffening member such that the wing extends over only a portion of
the catheter adapter.
13. The method of claim 12 wherein the wing is molded over the
bottom of the catheter adapter.
14. The method of claim 9 wherein the means thereon for maintaining
the position of the stiffening member is a hole defined by the
stiffening member.
15. The method of claim 14 further comprising the step of locating
a pin through the hole defined in the stiffening member.
16. The method of claim 15 wherein the pin forms a hole in the wing
adjacent to the hole defined in the stiffening member.
17. The method of claim 9 wherein the means thereon for maintaining
the position of the stiffening member is a first support extending
upwardly from the stiffening member.
18. The method of claim 9 wherein the means thereon for maintaining
the position of the stiffening member further includes a second
support extending downwardly from the stiffening member.
19. A catheter assembly, comprising: a translucent catheter; and a
catheter adapter defining a main body portion having a translucent
top portion and having at least one wing extending from a bottom
portion of the catheter adapter and a stiffening member disposed in
the wing, wherein the wing defines a suture hole extending through
the wing and the stiffening member.
20. The catheter assembly of claim 19 wherein the stiffening member
is formed from a first material and the wing is formed from a
second material.
21. The catheter assembly of claim 20 wherein the first material is
more rigid than the second material.
Description
BACKGROUND OF THE INVENTION
[0001] The subject invention relates to an intravascular ("IV")
medical device. More specifically, this invention relates to an IV
catheter that is adapted to be affixed to the patient's skin. Even
more specifically this invention relates to an IV catheter having
wings that are each formed with a stiffening member therein. In
addition, this invention relates to a catheter wing and stiffening
member configuration and method for forming the catheter wing and
stiffening member that maintains the ornamental and functional
features of the wing and stiffening member. The invention results
in a catheter wing that facilitates the introduction of the
catheter into a patient's vasculature yet maximizes patient comfort
when the wing is affixed to the patient's skin.
[0002] In order properly to place an IV catheter into a patient,
the catheter is typically mounted over an introducer needle having
a sharp distal tip. At least the distal portion of the catheter
tightly engages the outer surface of the needle to prevent peelback
of the catheter and thus facilitates insertion of the catheter into
the blood vessel. The distal tip of the needle preferably extends
beyond the distal tip of the catheter with the bevel of the needle
facing up away from the patient's skin.
[0003] The catheter and introducer needle assembly is inserted at a
shallow angle through the patient's skin into a blood vessel. Some
catheters include wings, which may be used to facilitate this
venipuncture and to facilitate securing the catheter to the patient
as discussed below. The wings extend from either side of the
catheter or catheter hub and aid the clinician to precisely
manipulate and control the position of the catheter during
venipuncture. In some cases the wings may be folded together like
butterfly wings. In order to verify proper placement of the
catheter in the blood vessel, the clinician confirms that there is
flashback of blood in a flashback chamber. The flashback chamber is
typically formed as part of the needle hub. Once proper placement
of the catheter into the blood vessel is confirmed, the clinician
applies pressure to the blood vessel by pressing down on the
patient's skin over the blood vessel distal of the needle and the
catheter. This finger pressure occludes or at least minimizes
further blood flow through the needle and the catheter. The
clinician then withdraws the needle, leaving the catheter in place
for use in accordance with standard medical technique.
[0004] Peripheral IV catheters are short, and are typically on the
order of between about 1/4 of an inch and about 3 inches long.
Because of the shortness of the catheter, it is typically taped or
sutured to the patient's skin. Taping or suturing the catheter to
the patient's skin minimizes the possibility that the catheter will
become dislodged from the patient's vein if the patient moves or a
clinician manipulates the catheter to connect or disconnect an IV
line or other medical device. To facilitate this taping or
suturing, some catheters include wings extending about 180 degrees
apart from either side of the catheter hub. In some devices, the
ends of the wings include suture holes that allow the clinician to
sew the catheter directly to the patient's skin.
[0005] In order to maximize patient comfort, these wings are
typically formed from a soft and flexible material such as
silicone. This type of material is comfortable to the touch and has
no hard portions that could dig into the patient's skin causing
abrasions or pressure points. However, materials having the desired
softness for maximizing patient comfort may not have sufficient
rigidity to allow the clinician to precisely manipulate and control
the position of the catheter during venipuncture. Such softness and
flexibility could allow the wings to flex or fold so that when the
clinician grasps the catheter by the wings, the catheter may not be
properly aligned with the longitudinal and radial axis of the
wings. This makes it difficult for a clinician to use the wings to
control the location of the catheter with respect to the wing and
the venipuncture site. To date, an appropriate balance between
soft, flexible wings that maximize patient comfort when the
catheter is affixed to the patient's skin and hard, stiff wings
that maximize the ability of the clinician to precisely control the
catheter during venipuncture has not been found in available
devices.
SUMMARY OF THE INVENTION
[0006] It is therefore an object of this invention to provide a
catheter that maximizes patient comfort when the catheter is
affixed to the patient's skin and that also maximizes the ability
of the clinician to precisely control the catheter during
venipuncture.
[0007] It is another object of this invention to provide a catheter
wing configuration that balances the functional and ornamental
characteristics of wings formed from soft, flexible material and
wings formed from hard, rigid material.
[0008] It is yet another object of this invention to provide a
method for forming a catheter wing configuration that achieves the
objects of this invention.
[0009] This invention is particularly useful when applied to a
catheter, especially a catheter having an integrated extension tube
extending from the catheter adapter (an "integrated catheter"),
although it is to be understood that this invention is applicable
to other medical devices that require wings to facilitate both
affixing the device to the patient's skin or precisely manipulating
the medical device.
[0010] The catheter is coaxially disposed over the introducer
needle with the distal portion of the catheter tightly engaging the
outer surface of the introducer needle. This prevents peelback of
the catheter and facilitates insertion of the catheter into the
patient's blood vessel. Prior to use, the catheter is located about
the introducer needle so that the sharp distal tip of the
introducer needle is distal of the distal end of the catheter. The
proximal end of the catheter is connected to a catheter adapter. A
pair of wings extends about 180 degrees apart from either side of
the catheter adapter. The ends of each wing may define a suture
hole that allows a clinician to sew the wing, and thus the
catheter, directly to the skin of the patient.
[0011] The introducer needle has a sharp distal tip and a proximal
end connected to the distal end of a needle hub and preferably
includes at least one notch, i.e. a hole or opening in the
sidewall, therein in communication with the needle lumen. The notch
is formed in the introducer needle such that blood can flow into
the open distal end of the introducer needle, through the lumen in
the introducer needle and through the notch outside the introducer
needle into the catheter lumen. Thereafter, the blood can flow
through the annular space between the outside of the introducer
needle and the inside of the catheter and catheter adapter and then
through the side arm and extension tube that extends from the
catheter adapter. Preferably, the catheter, catheter adapter and
the extension tube are transparent or at least translucent. In this
way, the clinician can immediately and easily visualize flashback
of blood through these parts of the catheter assembly when the
introducer needle has been inserted into a patient's blood
vessel.
[0012] If desired, a needle shield movably disposed about the
introducer needle and located distally of the needle hub is defined
by a housing having an internal cavity through which the introducer
needle extends. A lock associated with the needle shield prevents
unwanted distal movement of the introducer needle once the
introducer needle has been proximally withdrawn into the needle
shield. Also associated with the needle shield is a means for
preventing unwanted proximal movement of the introducer needle once
the sharp distal tip of the introducer needle has been proximally
withdrawn into the needle shield.
[0013] The catheter wing includes a stiffening member disposed
therein. Preferably the wing is formed from a thermoplastic
elastomer. The stiffening member may be formed from the same
material used to form the catheter adapter and is preferably a
polycarbonate material or polyethylene phthalate glycol (PETG). The
soft, flexible material of the wing is comfortable to the touch and
covers any hard edges or other surfaces to prevent skin abrasion or
pressure points on the patient's skin when the wing is taped to or
sutured onto the patient's skin. The hard, rigid material of the
stiffening member provides rigidity to the wing to allow the
clinician to precisely control the position and movement of the
catheter.
[0014] Suture holes may be formed at the ends of each wing. These
suture holes provide a dual function. As is standard with all
suture holes, the suture holes of this invention provide a
mechanism that allows the clinician to sew the wings, and thus the
catheter, directly to the patient's skin, which fixes the catheter
in place. In addition, the suture holes provide a mechanism to hold
the stiffening members in place when the wings are formed. The
wings are formed by injection molding the wing material over the
stiffening members. Without some fixation device to hold the
stiffening members in place, the high pressure used during the
injection molding process will cause the stiffening members to
become dislodged with the result that they will not be located in
the optimum position within the wing. With the suture holes of this
invention, pins can be used during the molding process to precisely
locate the stiffening members with respect to the wing to be
overmolded thereon. This prevents the stiffening members from
becoming dislodged from their location even under the high pressure
of the injection molding process. Alternatively, the ends of the
stiffening members could be formed with upwardly and downwardly
extending integral pins. These pins in turn would sit in
appropriate holes formed in the mold to precisely locate the
stiffening members with respect to the wing to be overmolded
thereon.
BRIEF DESCRIPTION OF THE DRAWINGS
[0015] The preferred embodiments are illustrated in the drawings in
which like reference numerals refer to like elements and in
which:
[0016] FIG. 1 is a perspective view of an integrated catheter with
an introducer needle assembly that incorporates the wing and one
embodiment of the stiffening member of this invention ready for
use;
[0017] FIG. 2 is a top perspective view of the integrated catheter
shown in FIG. 1 with the wings and stiffening member in phantom but
without the extension tube attached to the side arm or the
introducer needle assembly;
[0018] FIG. 3 is a top plan view of a partially assembled
integrated catheter of FIG. 2 showing the catheter, the catheter
adapter, the side arm and the stiffening members prior to the wings
being overmolded thereon;
[0019] FIG. 4 is a top plan view similar to FIG. 3 but with the
wings overmolded on the stiffening members, which are shown in
phantom;
[0020] FIG. 5 is a bottom perspective view of the integrated
catheter shown in FIG. 2 with the wings and stiffening member in
phantom but without the extension tube attached to the side
arm;
[0021] FIG. 6 is a side elevation view, partially in cross section,
of the integrated catheter taken along line 6-6 of FIG. 4;
[0022] FIGS. 7 and 8 are schematic diagrams of the manufacturing
process for the wings and stiffening member of the integrated
catheter of FIG. 2;
[0023] FIG. 9 is a top plan view of the integrated catheter and
introducer needle assembly of FIG. 1 showing how a clinician could
hold the assembly to insert the integrated catheter into a
patient;
[0024] FIG. 10 is a perspective view showing the integrated
catheter of FIG. 1 taped to the patient's skin;
[0025] FIG. 11 is a perspective view showing the integrated
catheter of FIG. 1 sutured to the patient's skin;
[0026] FIG. 12 is a top plan view of a partially assembled
integrated catheter similar to FIG. 3 showing an alternative
embodiment of the stiffening members prior to the wings being
overmolded thereon; and
[0027] FIG. 13 is a side elevation view, partially in cross
section, similar to FIG. 6 showing the alternative embodiment of
the stiffening members used in an integrated catheter.
DETAILED DESCRIPTION OF THE INVENTION
[0028] As used herein, the term "proximal" refers to a location
with respect to the device that, during normal use, is closest to
the clinician and farthest from the patient. Conversely, the term
"distal" refers to a location with respect to the device that,
during normal use, is farthest from the clinician and closest to
the patient. As used herein, the term "top", "up" or "upwardly"
refers to a location with respect to the device that, during normal
use, is radially away from the longitudinal axis of the device and
away from the patient's skin. Conversely, as used herein, the term
"bottom", "down" or "downwardly" refers to a location with respect
to the device that, during normal use, is radially away from the
longitudinal axis of the device and toward the patient's skin. As
used herein, the term "in" or "inwardly" refers to a location with
respect to the device that, during normal use, is toward the inside
of the device. Conversely, as used herein, the term "out" or
"outwardly" refers to a location with respect to the device that,
during normal use, is toward the outside of the device.
[0029] This invention is described herein using like reference
numbers for like elements in the different embodiments. Although
this invention is described herein in connection with a peripheral
IV catheter having an integrated extension tube (an "integrated
catheter"), it is to be understood that this invention is
applicable to other catheters such as standard peripheral IV
catheters. In addition, it is to be understood that this invention
is applicable to catheter introducers and guidewire introducers and
other medical devices that are designed to be inserted into a
patient's vasculature using a standard over the needle insertion
technique. Finally, while this invention is satisfied by
embodiments in many different forms, there are shown in the
drawings and herein described in detail, preferred embodiments of
the invention with the scope of the invention measured by the
appended claims.
[0030] An integrated catheter and introducer needle assembly
including the wings and one embodiment of the stiffening members of
this invention is shown generally at 10 in FIG. 1. Catheter
assembly 20 includes a catheter 21 that has a proximal end, a
distal end and a catheter adapter 24 affixed to the proximal end of
catheter 21. Suitable materials for catheter 21 include, but are
not limited to, thermoplastic resins such as fluorinated ethylene
propylene (FEP), polytetrafluoroethylene (PTFE), polyurethane and
the like. Preferably, catheter 21 is formed from a thermoplastic
hydrophilic polyurethane that softens with exposure to
physiological conditions present in the patient's body. In
addition, the material used to form catheter 21 is preferably
transparent or at least translucent. In addition, if desired,
catheter 21 can be formed so that it is partially transparent or
translucent such as where catheter 21 is formed from stripes of
transparent or translucent material. This allows the clinician to
see blood flashback in the annular space between the introducer
needle 31 and catheter 21 where introducer needle 31 includes a
notch, i.e. a hole or opening in the sidewall, adjacent to its
distal end to allow such blood flow. Suitable materials for
catheter adapter 24 include, but are not limited to, thermoplastic
polymeric resins such as polycarbonate, polystyrene, polypropylene,
poly ethylene phthalate glycol (PETG) and the like. Preferably the
material used to form catheter adapter 24 is transparent or at
least translucent to allow the clinician to view blood flashback
therein. An integrated extension tube 25 extends from catheter
adapter 24 and may include a hub or some type of fluid access
device at its proximal end. See FIG. 1. Extension tube 25 may also
be translucent to allow the clinician to view flashback of blood
therein to confirm successful venipuncture. Details of such an
integrated catheter are described generally in U.S. Pat. No.
5,697,914.
[0031] Catheter adapter 24 includes a pair of wings 26 formed
thereon. Each wing 26 includes a stiffening member 27 disposed
therein. Wings 26 are preferably formed from a thermoplastic
elastomer such as those materials sold by Kraiburg under the
Thermolast K TF7MAA designation or by Multibase under the
Multi-Flex TEA 1004 designation. Preferably this material should
have a hardness in the range of between 60 Shore A and 85 Shore A,
although a hardness outside of this range would also be
appropriate. The soft, flexible material used to form wings 26 is
comfortable to the touch and covers the hard edges and other
surfaces of stiffening members 27 to prevent skin abrasion or
pressure points on the patient's skin when catheter adapter 24 is
taped to or sutured onto the patient's skin. Preferably, stiffening
members 27 should be more rigid than wings 26.
[0032] Wings 26 should be large enough to provide patient comfort
and to allow it to be effectively secured to the patient.
Preferably, wings 26 are located adjacent to the bottom of catheter
adapter 24. This ensures that the clinician will have a clear view
of the top of catheter adapter 24 and can thus immediately and
easily see blood flashback in catheter 21 and catheter adapter 24,
if they are formed from translucent material, to confirm successful
venipuncture.
[0033] The hard, rigid material of stiffening members 27 provides
rigidity to wings 26 to allow the clinician to precisely control
the position and movement of catheter assembly 20. Stiffening
members 27 should be large enough to provide the desired rigidity
of wings 26 but should not be so large as to adversely impact the
softness of wings 26. Preferably, each stiffening member 27 has a
longitudinal dimension, i.e. measured from its proximal end to its
distal end that is larger than its thickness, i.e. the dimension
measured from its top and bottom. For example, each stiffening
member preferably has a longitudinal dimension of about 0.175
inches and a thickness of about 0.015 inches. In addition, the
added rigidity provided by stiffening members 27 allows the
clinician to shape wings 26 to more closely match the contour of
the patient's skin and thus enhance patient comfort.
[0034] Suture holes 28 may be formed at the ends of each wing 26
and extend through the soft, flexible material forming wings 26 as
well as stiffening members 27. Suture holes 28 provide a dual
function. As is standard with all suture holes, suture holes 28
provide a mechanism that allows the clinician to sew wings 26, and
thus catheter assembly 20, directly to the patient's skin, which
fixes catheter assembly 20 in place. In addition, by forming suture
holes 28 so they extend through stiffening members 27, suture holes
28 provide a mechanism to hold stiffening members 27 in place when
wings 26 are formed.
[0035] Wings 26 are formed by injection molding the wing material
over stiffening members 27. Without some fixation device to hold
stiffening members 27 in place, the high pressure used during the
injection molding process will cause stiffening members 27 to
become dislodged or misoriented with the result that they could be
moved out of the optimum position within wings 26 and could in fact
extend out of the wings. By forming suture holes 28 of this
invention so they extend through stiffening members 27, pins 90
formed in the mold 99 can be used during the molding process to
precisely locate each stiffening member 27 with respect to each
wing 26 to be overmolded thereon. Pins 90 extend through the holes
formed in the end of each stiffening member 27 to fix one end of
each stiffening member 27 with respect to catheter adapter 24. The
other end of each stiffening member 27 is fixed to catheter adapter
24 because catheter adapter 24 and stiffening members 27 are
initially formed by injection molding these two elements as one
piece. With this arrangement, stiffening members 27 are not
dislodged from their location even under the high pressure of the
injection molding process. Pins 90 also ensure that suture holes 28
are formed in the material overmolded onto stiffening members 27.
See FIGS. 7 and 8.
[0036] An alternative means for precisely locating each stiffening
member 27 with respect to each wing 26 to be overmolded thereon is
shown in FIGS. 12 and 13. Instead of suture holes 28 formed in
stiffening members 27, a radially extending support 29 can be
formed on stiffening member 27. At least one such support 29 should
be used but preferably, each stiffening member 27 includes a pair
of supports 29 such that one extends upwardly and another extends
downwardly from the top and bottom respectively of each stiffening
member 27. Supports 29 engage holes (not shown) formed in mold 99
to precisely locate each stiffening member 27 with respect to each
wing 26.
[0037] Introducer needle assembly 30 includes introducer needle 31
having a sharp distal tip 32 defined by a bevel and a proximal end
connected to a needle hub 34. Introducer needle 31 is preferably
formed from stainless steel and has a longitudinal axis that is
generally parallel to the longitudinal axis of catheter and
introducer needle assembly 10. Introducer needle 31 may be formed
with a notch adjacent to the distal end. This configuration allows
blood to flow into the open distal end of introducer needle 31 and
then out of the notch into the annular space between catheter 21
and introducer needle 31. If catheter 21 is at least translucent,
the clinician will be able to observe blood flashback promptly upon
successful venipuncture. In addition, when the blood flows into
extension tube 25, if extension tube 25 is at least translucent,
the clinician will also be able to observe blood flashback there.
If desired and where no notch is formed in introducer needle 31,
needle hub 34 can include an integrated flashback chamber having an
open proximal end that is closed to fluid flow by a vented plug
which allows air but not fluid to flow therethrough. Needle hub 34
may be formed from the same types of materials that are used to
form catheter adapter 24. Of course, other materials could be used
to form needle hub 34.
[0038] Introducer needle assembly 30 also includes a needle shield,
which includes a housing defining an internal cavity therein with a
proximal opening and a distal opening in communication with the
internal cavity. This allows introducer needle 31 to extend
longitudinally through the housing. The lock that prevents unwanted
proximal and distal movement of sharp distal tip 32 of introducer
needle 31 out of the distal end of the needle shield once sharp
distal tip 32 has been proximally withdrawn into the needle shield
can take many forms. Such a lock does not comprise this invention.
The details of such a lock are described in U.S. patent application
Ser. No. 09/717,148 filed Nov. 21, 2000 (P-4203P1P1P1).
[0039] In order to place catheter 21 into a patient's blood vessel,
the clinician grasps the integrated catheter and introducer needle
assembly to substantially longitudinally align introducer needle 31
and catheter 21 with the target blood vessel. The clinician can
place her fingers along the front of wings 26 as shown in FIG. 9 to
stabilize and orient the assembly as needed. The bevel of sharp
distal tip 32 should be facing substantially away from the skin
surface during venipuncture so the distal opening to introducer
needle 31 is facing away from the skin surface. The clinician
inserts introducer needle 31 and catheter 21 at a shallow angle,
preferably less than about 35 degrees, into the skin so that sharp
distal tip 32 enters the target blood vessel. Where catheter 21,
catheter adapter 24 and extension tube 25 are made from translucent
material and a notch is formed in introducer needle 31, the
clinician will be able to observe blood flashback along catheter
21, in catheter adapter 24 and in extension tube 25. Alternatively,
where a flashback chamber is included in needle hub 34, the
clinician can observe blood flashback there.
[0040] After confirming placement of introducer needle 31 and
catheter 21 in the target blood vessel, the clinician advances
catheter 21 distally axially along introducer needle 31 into
position in the blood vessel. In certain techniques, introducer
needle 31 may be partially withdrawn into catheter 21 before
catheter 21 is completely advanced into position in the blood
vessel. After proper placement of catheter 21 is achieved, the
clinician places a finger from her other hand on the patient's skin
over the blood vessel approximately over the distal end of catheter
21. By placing her finger on the patient's skin and applying
sufficient pressure on the skin, the clinician thereby
substantially occludes or at least minimizes blood flow through
catheter 21. The clinician then withdraws introducer needle 31
completely from catheter 21 by moving needle hub 34 proximally.
This movement causes introducer needle 31 to move proximally into
the needle shield. Introducer needle 31 and the needle shield are
removed from catheter hub 24 and disposed of according to the
facility's disposal protocol. Thereafter, the clinician may then
attach a fluid delivery device, a PRN, a deadender cap or some
other blood monitoring device to extension tube 25 and commence the
planned treatment. Alternatively, such a device can be connected to
extension tube 25 prior to venipuncture. The clinician can then
bend wings 26 so they match the contour of the patient's skin and
suture catheter assembly 20 to the patient's skin using suture
holes 28. Alternatively, the clinician can tape catheter assembly
20 to the patient's skin.
[0041] Thus, it is seen that a catheter is provided that maximizes
patient comfort when the catheter is affixed to the patient's skin,
that also maximizes the ability of the clinician to precisely
control the catheter during venipuncture, and that balances the
functional and ornamental characteristics of wings formed from
soft, flexible material and wings formed from hard, rigid material.
It is also seen that a method is provided that facilitates the
manufacture of the catheter described herein.
* * * * *