U.S. patent number 3,888,249 [Application Number 05/412,199] was granted by the patent office on 1975-06-10 for arterial infusion catheter.
Invention is credited to David L. Spencer.
United States Patent |
3,888,249 |
Spencer |
June 10, 1975 |
Arterial infusion catheter
Abstract
A catheter for prolonged infusion of medication into an artery.
The catheter has a unique tip design employing the flap valve
principle to assure uniform and steady diffusion of the medication
into the bloodstream and also to inhibit retrograde flow of blood
into the catheter thereby minimizing clotting and the resulting
blockage of the medication flow.
Inventors: |
Spencer; David L. (Chicago,
IL) |
Family
ID: |
23632004 |
Appl.
No.: |
05/412,199 |
Filed: |
November 2, 1973 |
Current U.S.
Class: |
604/247;
604/523 |
Current CPC
Class: |
A61M
25/0021 (20130101); A61M 25/0075 (20130101); A61M
25/007 (20130101); A61M 25/0023 (20130101); A61M
2025/0076 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61m 005/00 (); A61m
025/00 () |
Field of
Search: |
;128/214R,214.4,240,241,348,349R,349B,349BV,35R,35V,351,274 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Reynolds et al. -- Surgery, Dec. 1965, Vol. 58, No. 6, pp.
938-940..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Nemmers; James C. Simmons; Haven
E.
Claims
I claim:
1. A catheter for use in arterial infusion of fluids and the like,
said catheter comprising a cannula formed of a material
sufficiently rigid to facilitate insertion thereof into an artery,
said cannula having a distal end and a proximal end, a part of said
cannula at the distal end having a plurality of cutout portions
spaced around the circumference of said cannula and separating said
distal end from the main body of the cannula, said cutout portions
being separated by ribs extending longitudinally between the main
body of said cannula and its distal end which ribs are formed
integrally with said cannula, a flexible material extending
completely over each of said cutout portions along the inside
surface of said cannula and having a modulus of elasticity less
than the modulus of elasticity for the material which forms said
cannula, the flexible material covering each of said cutout
portions having a plurality of slits therein to provide for
discharge of fluid from inside of said cannula through said slits
when the fluid pressure in said cannula exceeds the pressure on the
outside of said cannula which preventing the retrograde flow of
fluid into said cannula regardless of the pressure difference
between the inside and outside of said cannula.
2. The catheter of claim 1 in which there is at least one row of
slits in the flexible material covering each of said cutout
portions, the said row extending longitudinally along the cutout
portion, and said cutout portions extend around the entire
circumference of said cannula between said ribs.
Description
BACKGROUND OF THE INVENTION
In the care and treatment of hospitalized patients, catheters of
various types are used to carry out the necessary treatments. Some
catheters are used for drainage, some for infusion and some for
both purposes. Also, depending upon the particular treatment, the
catheters may be used for either short term or prolonged treatment.
In the area of regional intra-arterial infusion, catheters are used
to inject or infuse medication into the bloodstream. For example,
in certain malignant tumors, arterial catheters are used for the
regional infusion of chemotheraputic agents over prolonged periods.
Thus, once the catheter has been inserted, it can be fixed in place
and utilized for continuous infusion or for periodic infusion over
prolonged periods. In this manner, the trauma of repeated punctures
and re-insertions of the catheter can be kept to a minimum.
However, in using prolonged intra-arterial infusion several
difficulties are encountered. Quite frequently, the blood will clot
around the distal end of the catheter and cause premature cessation
of the treatment. Also, with arterial catheters of presently known
design, there is an inadequate mixing of the medication with the
bloodstream which results in sporadic and unpredictable drug levels
at the sight of the lesion. When clotting around the end of the
catheter occurs resulting in blockage of the flow of medication,
the catheter must be withdrawn, cleaned and reinserted. Since
clotting is unpredictable, the infusion process must be closely
watched so that cessation of the flow of medication can be quickly
detected and corrective action taken. Thus, patients receiving
medication through intra-arterial infusion must be closely watched
and if problems result the patient quite often must suffer the
trauma of withdrawal and re-insertion of the catheter a number of
times during the course of the treatment. It is a principal object
of my invention to overcome these disadvantages of prior art
catheters so that more effective treatment can be accomplished with
a minimum of trauma and pain to the patient.
SUMMARY OF THE INVENTION
The invention provides a catheter design in which the distal end
inserted into the artery is provided with a flexible portion
containing one or more slits which serve as valves. When positive
pressure is applied to start the infusion process, the slits will
open and allow the medication to enter the arterial flow of blood.
During the time that positive pressure is being applied, clotting
cannot occur to block the flow, and if the positive pressure is
withdrawn the slits will close to shut off the flow of medication
and inhibit the retrograde flow of blood into the catheter thereby
preventing blockage of the catheter. Also, with the multiple valve
design of the catheter, and using positive pressure to inject the
medication, greatly improved diffusion of the medication into the
bloodstream is achieved.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of a portion of an artery, partly in section, and
showing a catheter employing the principles of the invention in
place in the artery;
FIG. 2 is a perspective view of the end of the catheter and showing
the valves in a closed position;
FIG. 3 is a sectional view taken on line 3--3 of FIG. 2;
FIG. 4 is a perspective view similar to FIG. 2 but showing the
valves in an open position;
FIG. 5 is a sectional view taken on the line 5--5 of FIG. 4;
FIG. 6 is a perspective view showing the tip of a catheter
employing the principles of the invention as disclosed in another
embodiment thereof; and
FIG. 7 is a view similar to FIG. 6 but showing the valves of the
catheter of the second embodiment in an open position.
DESCRIPTION OF THE PREFERRED EMBODIMENTS OF THE INVENTION
In FIG. 1 there is shown in section the wall 10 of an artery 12 in
which the flow of blood is in the direction indicated by the
arrows. In employing the technique of intra-arterial infusion, the
artery in punctured by a suitable instrument (not shown) and then
the tip of a catheter 14 is inserted to the desired depth and with
its distal end 16 pointing downstream. The catheter 14 consists of
a cannula or hollow tube 18 the proximal end 19 of which is
attached to a source of medication (not shown). By force of gravity
or other means of applying a positive pressure, the medication
flows through the tube 18 and is discharged through the distal end
16 into the bloodstream.
At or near the distal end 16 of the catheter 14 the tube 18 is
provided with a plurality of cutout portions or windows 20 which
are formed in between connecting ribs 22 that interconnect the tube
18 and the distal end 16 of the catheter 14. Each of the windows 20
is covered with a material having a modulus of elasticity less than
the material from which the tube 18 is made. Formed in the material
covering each of the windows 20 is a plurality of cuts or slits 24
which provide valves through which fluid introduced into the
catheter 14 may be discharged. As best seen in FIGS. 2 and 3, when
the pressure inside of the catheter 14 is approximately that of the
blood in the artery 12, the valves 24 will be closed thus
preventing both the flow of medication from the catheter 14 and
retrograde flow of blood into the catheter 14. However, when the
pressure applied to the medication in the catheter 14 is slightly
greater than the blood pressure, the valves 24 will open, as best
seen in FIGS. 4 and 5. Opening of valves 24 allows the medication
of flow outwardly through each of the valves 24 and into the
bloodstream of artery 12. Because there are a plurality of valves
24 provided around the entire circumference of the catheter 14 near
its distal end 16, this allows the medication to be discharged
uniformly and evenly thus providing greatly improved diffusion of
the medication into the bloodstream and eliminating sporadic and
unpredictable drug levels at the injection site. If the prolonged
treatment requires repeated, regular injections of medication for
limited periods of time, the catheter 14 is left in place, and the
positive pressure applied to infuse the medication is stopped after
each injection and the valves 24 will close preventing the
retrograde flow of blood into the catheter 14. With prior art
devices, the blood in the artery 12 would tend to clot at the site
of the lesion sometimes even during treatment, and would start to
clot immediately after treatment was discontinued if the catheter
was left in place. The invention eliminates these problems by
allowing the catheter 14 to be inserted and left in place during
the entire time of the treatment without clogging even though the
treatment may be quite prolonged.
In FIGS. 6 and 7 there is shown another embodiment of the
invention, and parts corresponding to those of the first embodiment
will be referred to by the same reference numeral followed by the
latter a. Thus, in the second embodiment, the catheter 14a includes
a cannula or tube 18a having a distal end 16a. At the distal end
16a of tube 18a there is provided a valve tip 30 which is formed of
a material having a modulus of elasticity less than the material
from which the tube 18a is formed. The valve tip 30 is affixed to
the distal end 16a in any suitable manner and completely encloses
the otherwise open end of the tube 18a. Formed around the periphery
of the valve tip 30 are a plurality of slits or valves 24a. In FIG.
6, the slits or valves 24a are shown in a closed position which is
their condition if the pressure inside of the catheter 14a is
approximately that of the blood inside of the artery 12. In FIG. 7,
the valves 24a are shown in an open position which will occur if
the pressure applied to the medication inside of the catheter 14a
is greater than the blood pressure in the artery 12. The second
embodiment of FIGS. 6 and 7 has all of the advantages and features
of the first embodiment, the only difference being that the
catheter 14 of the first embodiment has a distal end 16 of a
relatively hard material thus facilitating insertion. On the other
hand, the catheter 14a of the second embodiment has a soft easily
deformable valve tip 30. In either case, the insertion technique is
the same with the catheter being inserted immediately after the
artery wall 10 is punctured with a suitable instrument.
A catheter employing the principles of the inveniton is of
tremendous benefit in any procedure requiring the prolonged
infusion of medication into the arterial tree either continuously
or periodically over a prolonged time. Also, a properly designed
catheter employing the principles of the invention may be used for
intermittent intravenous administration of all types of medications
including such techniques as the scalp-vein heparin lock technique.
It will be obvious to those skilled in the art that a variety of
techniques and treatments can be employed with a catheter made
according to the principles of the invention.
I have described my invention in connection with two preferred
embodiments thereof. It will be obvious to those skilled in the art
that the materials used in the catheter can be of any suitable
material, it being important only that the valve portion have a
modulus of elasticity less than the cannula. the number, size and
actual placement of the slits which form the valves can be varied
as will be obvious to those skilled in the art. Obviously,
catheters can be built according to the invention in various
diameters with various specified rates of flow, the rate of flow
being a function of the infusion pressure, the modulus of
elasticity of the valve segment, the thickness of the valve
segment, diameter of the catheter and number and size of the slits
forming the valves.
It will be further obvious that various revisions and modifications
can be made in the specific preferred embodiments disclosed herein
without departing from the spirit and scope of the invention. It is
my intention, however, that all such revisions, modifications and
uses will be included within the scope of the following claims.
* * * * *