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Description  |
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BACKGROUND OF THE DISCLOSURE
This disclosure relates to the hollow molded plastic adapter body which
fits between a flexible plastic catheter and the out flow connection of
the tube from an administration set. The adapter body is tapered and
hollow having a diametrically larger inlet opening at the proximal end
than the outlet opening at the distal end. Flexible wings extend from the
adapter body for purposes of handling and then securing to the patient. At
the distal end this adapter body is provided a fastener connection means
such as luer lock threads about the proximal end inlet and a reduced tip
for attachment to the end of a flexible catheter tube at the distal end
outlet. In use, the adapter body is designed for an over-the-needle
insertion procedure. That is to say that, the adapter and its catheter are
coaxially carried by a hollow needle during insertion into a human blood
vessel. The needle coaxially carries the catheter tightly thereabout and
the two are inserted together as a unit with the needle tip penetrating
and making an opening followed by the leading (distal) end of the
catheter.
In order to facilitate this procedure, the tip of the catheter is chamfered
or beveled so that as the needle is placed into the vein; it will easily
carry with it the catheter. Similarly, the needle is beveled to facilitate
penetration into the blood vessel and the orientation of the bevel
relative to the adapter body is important due to the relationship between
the wings and the needle. The needle bevel relative to the blood vessel
lumen is such that the tip or point of the needle is furtherest from the
skin surface during placement, for example, bevel upwardly. Once the
catheter is placed within the vessel the needle can be axially extracted
and this is done by holding the adapter body by, for example, placing the
wings to which the catheter adapter is attached against the patient's
flesh and withdrawing the needle by means of the flash back chamber
attached at the end of the needle opposite the beveled point or tip.
Adapter bodies have been made with a variety of shapes and configurations
such as for example, those shown in U.S. Pat. Nos. 3,348,544, 3,352,306,
3,406,685, 3,515,137, 3,595,230, 3,895,632, and 4,292,970. These shapes
and configurations serve to facilitate handling and a variety of other
useful purposes. However, none of these or other adapters have been
specifically designed to guarantee suture securement of the catheter to
the patient and/or the holding of same within the blood vessel.
In particular, the problem of the catheter inadvertently retracting from
the blood vessel with blood loss or the loss of the intravenous site is a
serious one since it threatens infection and/or bleeding. The additional
pain caused to the patient from another catheter placement is also of
great concern. As mentioned, catheter adapters have carried means for
securement of same to the patient such as for example, wings for adhesive
taping to the patient's skin. For suturing such wings have holes at their
extremities. While the suturing technique is more secure than taping, wing
suturing has problems. The holes in the wings are located laterally spaced
away from the adapter body and when the wings are flexible, the displaced
location of the holes can allow axial displacement of the adapter body.
That is to say that, when the wings are made fragile and flexible in order
to adapt to the contour of the patient's body. Suturing tied through the
tips of the wings in the premade holes tends to aggravate a stress
condition and give a loose attachment. The suture thread is very thin as
is the cross section of the flexible wing, thus resulting in a potential
for tearing either of the skin of the patient or the cross section of the
wing.
OBJECTS OF THE DISCLOSURE
Consequently, an arrangement whereby the entire rigid body of the adapter
can be securely affixed to the patient by means of a suture is required.
The means of fixation should be adapted to resist the pull out of the
catheter from the blood vessel and should hold the catheter in position to
minimize the effects of internal lumen injury, such as abrasion,
mechanical phlebitis, etc., i.e. to the inside surface of the blood vessel
as a consequence of any relative motion between the catheter and the
lumen.
In order to resolve the problems of the prior approaches and meet the needs
of the product, a specifically shaped adapter body has been constructed in
accordance with the description of the preferred embodiment which follows
herein; such an adapter body satisfies the safety and performance needs
heretofore unfulfilled.
SUMMARY OF THE INVENTION
An adapter is shown for use in combination with a catheter in an
over-the-needle insertion procedure. The adapter includes laterally wings
extending from an elongated hollow tubular body having distal and proximal
end openings aligned along a common axis of the hollow tapered tubular
body. The catheter is in fluid communication with and extends from the
distal end opening of the hollow adapter body. The other end of the hollow
tubular adapter body forms a fastener such as a luer lock connection. This
facilitates the attachment of the adapter to the tubing fitting from an
administration set for the introduction of for example, blood or saline.
Along the patient contacting surface of the adapter body is a flat,
generally planar, support surface that extends outwardly in a lateral
fashion to form thin flexible wings.
The planar surface is angled relative to the axis of the adapter body in
order to tip the distal end of the body toward the patient, thus
positioning the catheter for location in the blood vessel. As a result of
this angularity, the catheter extends from the body without kinking
between its connection to the adapter tip and the entrance to the skin.
The catheter axis lies generally along a line which is nearly parallel to
the central axis of the blood vessel once the catheter is placed within
the lumen. This is a consequence of the position of the planar surface of
the adapter against the flesh.
Transverse to the axis of the adapter body opposite the planar surface is a
saddle formed from a pair of upstanding ribs, a suture drawn between these
ribs may be extended across the proximal portion of the wings at their
juncture with the sides of the adapter body. The suture can also be sewn
through the wings and into the flesh or skin of the patient. Either
approach will assure that the adapter body and supported catheter will not
move axially relative to the insertion site in the blood vessel.
The angular placement of the winged/planar surface is such that the radial
extent of the luer lock fitting at the proximal end of the tubular adapter
body and the radial extent of the catheter connection at the other end of
the tubular body are generally in the plane of the wings whereby any
concern about rocking of the catheter support adapter body either
longitudinally or laterally is overcome by this particular geometric
construction.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a side elevational view of the adapter of the preseut invention
showing same sutured with a wrap and tie,
FIG. 2 is a top plan view of the adapter in FIG. 1,
FIG. 3 is a side elevational view of the adapter of the present invention
showing same with a suture passing through the wings close to the body,
FIG. 4 is a top plan view of the sutured adapter in FIG. 3,
FIG. 5 is a side elevational view of the adapter of the present invention
showing same with a suture once across the saddle and adJacent the body
extending to the back of the wings, and
FIG. 6 is a top plan view of the adapter in FIG. 5.
DETAILED DESCRIPTION OF THE DRAWINGS
FIGS. 1, 3, and 5 are similar side elevational views of the adapter 10, the
only difference being the way in which the adapter is sutured, suture
knots are not specifically shown. The main reference numbering for the
parts in FIGS. 1 through 6 is identical.
Adapter 10 constructs of an elongated hollow tubular body 11 which is
tapered about an axis A. The distal end 12 is small end and the proximal
end 13 is the large end of body 11. The opening for the small or distal
end 12 is designated 12a and shown best in FIG. 1 and the opening for the
large end or proximal end 13 is designated 13a. Specifically, a portion of
the catheter 14 is shown in section where it attaches to the distal end
opening 12a also in section. The catheter 14 extends axially from opening
12a along axis "A" and has a bevelled or tapered tip to ease insertion in
an over-the-needle technique during placement into a blood vessel.
At the proximal end 13 of the adapter body 11 there is provided a set of
male luer lock threads 15 designed to receive the standard luer lock
female nut. These threads are molded as part of the adapter body 11 and
circumscribe the opening 13a at the proximal end 13 of the adapter 11. In
FIGS. 1, 3, and 5, the radially extending portion 15a at the bottom of the
threads 15 defines one point of a plane B (also shown in these figures).
Another point in plane B is located at the distal end 12 and more
specifically the radially extended portion of the bottom of the distal end
opening designated 12b. While plane B is shown as merely a line in FIGS.
1, 3, and 5, and because more than two points are needed to describe a
plane, it is clear from the top plan views in FIGS. 2, 4 and 6; that the
wings 16 are in plane B and described at least a third point which is not
on the line extending between portion 15a and 12b on the threads 15 and
tip 12. The wings 16 are positioned to extend laterally from the base or
patient contacting portion of the body 11. The wings are symmetric about
the body having one wing on each side of the body opposite one another
being the mirror image of one another. The angle C at which plane B
intersects axis A as shown in FIGS. 1, 3, and 5 is approximately 6.75
degrees or about 7.0 degrees. The wings 16 are molded as part of the body
and are thin. Flexibility of the wing results from the thin cross-section
and the material selected. Longitudinal reinforcement ribs extend parallel
to the axis of the axis A of the body 11 and inner rib is designated 16b
and the outer rib near the tip of each wing is designated 16c. These ribs
help constrain flexure of the wings. Disposed between the two ribs through
the wing is a suturing hole 16d. The rear or proximal edge of the wing 16
where it joins the body 11 is called juncture 16a. This location is
critical to the suturing function as will be explained in detail with
respect to the suturing material. Wing 16 is positioned in plane B by the
base or bottom of the body 11 immediately above the wing 16. Body 11 along
its bottom is formed with an angled spacer 11a that extends radially from
the axis to a greater extent at the proximal end than it does at the
distal end where the body 11 meets the wing 16.
On the side of the body 11 opposite the wing 16 there is provided a saddle
17 formed by a pair of transversely extending upstanding ridges 17a and
17b. Ridges 17a and 17b define therebetween a saddle 17 and are positioned
longitudinally relative to the body 11 such that ridge 17a is generally
laterally in line with Juncture 16a. Ridge 17b is spaced forwardly
therefrom at least two to three times the thickness of suturing material
to permit same to be looped thereacross during securement of the adapter
10 to the patient. Suture material, fashioned of braided silk and having a
diameter of 0.010 inches designated size 3-0 can be used for holding the
adapter body 11. In FIGS. 1 through 6, the suturing material is generally
designated 18 and may be any type of material generally used for surgical
suturing whereby same can be wrapped, tied or sewn in any of the ways
normally used by surgeons. The body 11 has one more feature to aid adapter
10 tie down and that is a hemispherically shaped downwardly depending nib
19 positioned between the radially extending portion 15a of the threads 15
and the area of juncture 16a i.e. between the rearwardly or proximal end
of the wing 16 and the body 11. While only two ridges 17a and b are shown
more could be provided.
As seen in FIGS. 1 and 2, the suture 18 is looped twice around the body 11;
once through the saddle 17, and down through and between the nib 19 and
the rearward juncture 16a before being secured by sewing through the flesh
as indicated by a discontinuity in the suture material just beneath and
aft of the wing 16 in FIGS. 1 or 2. This technique for suturing provides a
fore and aft and a side to side securement of the adapter 10 to the
patient. With regard to fore and aft or longitudinal movement, the point
at which the suture 18 bears against the adapter 10 near juncture 16a,
FIG. 1 prevents longitudinal movement which would pull the catheter 14 out
of the patient's blood vessel. That is because the suture goes through the
saddle 17 and bears against the rearward edge of the wings 16 at the
juncture 16a with the body 11. Side to side or lateral movement is of
course restrained by the way in which the suture 18 is tied to the
patient. For purposes of clarity and illustration, this is shown merely by
sewing the suture through the patient and out again. However, often times
suturing material is tied to the patient through a small pinch of skin and
then a leg or legs of suture are extended from the tie site to the adapter
10 and wrapped thereabout before being brought back to that tie site or to
a different tie site. There are a multitude of possibilities of suturing
techniques possible but to simplify illustration all are not shown.
FIGS. 3 and 4 show the same style adapter 10 with another suturing scheme
in particular the suture 18 is here sewn directly through the wing 16
where same joins body 11 directly under the saddle 17, see FIG. 4. This is
done by merely driving the suturing needle (not shown) through the adapter
10 at the wing 16. As the wing 16 is particularly flexible. Again the
suture 18 holds the adapter body 11 from longitudinal movement by means of
the securement due to the sewing through the wing 16 and subsequent
connection to the patient by means of a site as shown by the discontinuity
in the suture 18 illustrated essentially beneath or after the wing 16 in
FIGS. 3 and 4.
Finally in FIGS. 5 and 6 a third possibility for securing the suture 18
relative to the patient is shown. In FIGS. 5 and 6 the suture 18 is again
looped over the saddle 17 and across the Junctures 16a on both sides of
the body 11 but the suture 18 is drawn across and under the body as shown
in FIG. 5 to the tie site. This approach is similar to FIGS. 1 and 2
without the double wrap. The tie down to the patient in connection with
FIGS. 5 and 6 is identical. Again the longitudinal movement is restrained
by the positioning of the suture 18 relative to the juncture 16a near the
body 11. The nib 19 once again acts to position the suture 18 where same
drops beneath and across the bottom of the adapter 10.
While three specific methods of tying sutures relative to the adapter body
11 have been shown and described, the invention is the geometrical
configuration of the adapter 10 which facilitates the use of suturing
material to provide a securement of the adapter 10 to the patient thus
preventing longitudinal withdrawal of the catheter from the blood vessel.
Skilled artisans will no doubt conceive of a myriad of approaches useful
to and which take advantage of the saddle 17 in cooperation with the
angled wings 16 to provide a simple and secure attachment of the adapter
10 to the patient during catheterization. It is intended in the claim
which follow that the structural and configurational features of the
adapter 10 disclosed herein will be suitably protected for any and all
purposes and functions to which the adapter 10 may be properly put in
securing the catheter adapter.
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