U.S. patent number 3,612,050 [Application Number 04/812,102] was granted by the patent office on 1971-10-12 for intravascular catheters.
Invention is credited to David S. Sheridan.
United States Patent |
3,612,050 |
Sheridan |
October 12, 1971 |
INTRAVASCULAR CATHETERS
Abstract
Intravascular catheters of improved vascular insertability are
made with a plastic catheter snugly encircling a trocar. The
catheter is tapered at the distal end which is blended with the
exterior wall of the trocar, e.g., by being shrunk into a groove in
the trocar wall. This structure permits smooth intravasculary entry
of the catheter and reduces occurrence of phlebitis in the use of
intravascular catheters.
Inventors: |
Sheridan; David S. (Argyle,
NY) |
Family
ID: |
25208506 |
Appl.
No.: |
04/812,102 |
Filed: |
April 1, 1969 |
Current U.S.
Class: |
604/166.01;
D24/112 |
Current CPC
Class: |
A61M
25/065 (20130101); A61M 25/0606 (20130101); A61M
2025/0687 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61m 005/00 () |
Field of
Search: |
;128/214.2,214.4,221,DIG.16,348 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
The embodiments of the invention in which an exclusive property or
right is claimed are defined as follows:
1. An intravascular catheter assembly comprising:
a. a trocar adapted to pierce a vascular wall to create an opening
therethrough,
b. said trocar having a sharp-angled tip and a longitudinal tubular
body of substantially uniform diameter extending rearwardly of said
tip,
c. an arcuate concave groove in the exterior wall of said trocar
adjacent said angled tip,
d. a plastic catheter having a distal end tip and a substantially
uniform lumen throughout its length approximately equal to the OD
of said tubular body extending proximally of said tip, the catheter
being fitted over the trocar snugly encircling it,
e. the exterior wall of the distal end portion of the catheter
being tapered toward said catheter tip, said tip being smoothly
rounded, and
f. said tip having a smoothly rounded convex constriction that
extends radially inwardly, said constriction filling said concave
groove in said trocar wall.
Description
BACKGROUND OF THE INVENTION
Intravascular catheters are required in the variety of medical and
clinical procedures for the administration of fluids of various
types into the vascular system of a patient or for the removal of
body fluids from the vascular system. The intravascular catheter is
placed in the vascular channel by puncturing a hole through the
skin and vascular channel wall and installing the intravascular
catheter. Assemblies for accomplishing this comprising a trocar and
an encircling catheter have been developed (see U.S. Pat. No.
3,313,299).
Numerous procedures performed on a patient using intravascular
catheters require the catheters to remain positioned within the
vascular channel for extended periods of time. Use of available
intravascular catheters has resulted in frequent occurrence of
phlebitis and there is a need for improvements in these medical
devices which will serve to migitate or entirely eliminate
phlebitis resulting from the use of intravascular catheters.
Another difficulty connected with use of intravascular catheters is
irritation or damaging of the vascular wall upon insertion of the
catheter. This can occur from the action of the tip of the catheter
as it is forced through the vascular wall if it surrounds the
stylet or trocar used to puncture the wall for the insertion.
OBJECTS
A principal object of this invention is the provision of new
improvements in the construction of intravascular catheters.
Further objects include the provision of:
1. Intravascular catheter assemblies of improved form which reduce
occurrence of phlebitis in the use of intravascular catheters.
2. A new combination of trocar adapted to install an intravascular
catheter within a vascular channel and an encircling catheter
involving complementary structural features which aid in obtaining
correct, noninjurious placement of the intravascular catheter and
mitigation or elimination of inflammation of the vascular wall and
phlebitis which may occur from intravascular placement of the
catheter.
Other objects and further scope of applicability of the present
invention will become apparent from the detailed description given
hereinafter; it should be understood, however, that the detailed
description, while indicating preferred embodiments of the
invention, is given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description. It should also be understood the
foregoing abstract of the disclosure is for the purpose of
providing a nonlegal brief statement to serve as a
searching-scanning tool for scientists, engineers and researchers
and is not intended to limit the scope of the invention as
disclosed herein nor is it intended it should be used in
interpreting or in any way limiting the scope or fair meaning of
the appended claims.
SUMMARY OF THE INVENTION
These objects are accomplished according to the present invention
by forming an intravascular catheter assembly to include a trocar
and a plastic catheter snugly encircling the trocar, with the
catheter being tapered at the distal end, the tapered end in turn,
being blended to the exterior wall of the trocar. The catheter tip
which is formed in this manner presents a smooth-rounded orifice
free of sharp edges or the like which can inflame the vascular
channel wall when the catheter is installed within the vascular
channel. Furthermore, the geometry of the new catheter assemblies
ensures a minimum of irritation or injury to the vascular wall
during installation of the catheter and subsequent withdrawal of
the trocar. Several constructions are used to obtain the necessary
blending of the catheter to the trocar exterior wall.
In a preferred embodiment, the new intravascular catheter
assemblies comprise:
a. a tubular trocar adapted to pierce a vascular wall to create an
opening therethrough,
b. said trocar having a sharp-angled tip and a longitudinal tubular
body of substantially uniform diameter extending rearwardly of said
tip,
c. a concave groove in said tubular body adjacent said tip,
d. a plastic catheter substantially uniform lumen throughout its
length approximately equal to the OD of said tubular body, the
catheter being fitted over the trocar snugly encircling it,
e. a distal end portion on the catheter which is tapered toward the
catheter tip, and
f. a convex constriction extending radially inwardly on said
catheter tip, the convexity of the constriction being complementary
to the concavity of said groove,
g. said constriction being fitted into said groove in said
assembly.
In another preferred embodiment, the new intravascular catheter
assemblies, instead of having a convex constriction on the catheter
tip to complement the trocar groove, has the catheter tip shrunk
into a groove or undercut in the exterior wall of the trocar.
In yet another preferred embodiment, no groove or undercut is made
in the trocar exterior wall. Instead, the wall is roughened, e.g.,
by sandblasting, or scored, e.g., by circumferential cutting or
milling, and the tapered tip of the catheter is shrunk into the
roughened or scored trocar wall.
BRIEF DESCRIPTION OF THE DRAWING
A more complete understanding of the new intravascular catheters of
this invention and their method of use may be had by reference to
the accompanying drawing in which:
FIG. 1 is a plan view of an intravascular catheter assembly
constructed in accordance with the invention.
FIG. 2 is an enlarged fragmentary view partly in section showing
the distal end portion of the catheter assembly of FIG. 1.
FIG. 3 is an enlarged fragmentary view partly in section related to
FIG. 2 but illustrating the trocar of the catheter assembly being
withdrawn from the intravascular catheter.
FIG. 4 is a plan view of another embodiment of an intravascular
catheter assembly in accordance with the invention.
FIG. 5 is a plan view of the trocar unit of the assembly shown in
FIG. 4.
FIG. 6 is a plan view of the catheter of the assembly shown in FIG.
4 prior to association with the trocar shown in FIG. 5.
FIG. 7 is an enlarged fragmentary sectional side view of the distal
end of the catheter of FIG. 6.
FIG. 8 is an enlarged fragmentary side view, partially in section,
of the distal end portion of the catheter assembly shown in FIG.
4.
FIG. 9 is an enlarged fragmentary side view, partially in section,
of another embodiment of the new catheter assemblies.
FIG. 10 is an enlarged fragmentary side view, partially in section,
of another embodiment of the new catheter assemblies.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
Referring in detail to the drawings, the intravascular catheter
assembly 2 comprises a trocar 4 and a plastic catheter 6.
The trocar 4 has a sharp tip 8 which angles from the point 10 to
the tip base 12 suitably ground or otherwise formed upon the end of
the longitudinal tubular body 14. The opposite end of the trocar
comprises end means 16 which can be used to receive a cap or plug
to close the longitudinal bore 18 of the trocar against flow of
fluid therethrough. The end means 16 may be a metal hub formed with
a tapered female opening 19, a molded plastic unit or the like that
is suitably attached such as by welding, press fit, cementing or
the like to the rigid longitudinal tubular body 14 of the trocar.
Advantageously, the trocar 14 is a standard type of stainless steel
hypodermic needle with the conventional syringe fitting metal hub
16 into which a groove 20 has been formed.
The concave groove 20 is formed in the tubular body 14 adjacent the
tip 8 of the trocar 4. Advantageously, the base of the groove 20 is
represented by the arc of a circle permitting smooth manipulation
of the plastic catheter portion of the assembly as described
hereinafter. However, the groove 20 may assume other
configurations. The distance of the groove 20 from the trocar point
10 may be varied, but most satisfactory results in vascular wall
penetration and insertion are obtained if the distance from the
trocar tip base 12 to the groove 20 is less than the distance from
the base 12 to the trocar tip 10. Further, the trocar tips of the
preferred angle a, i.e., less than 45.degree., the distance from
the base 12 of the angled tip 8 to the groove 20 is greater than
the outside diameter of the tubular body 14.
The plastic catheter 6 comprises a distal end portion 22 which
tapers from the catheter tip 24 rearwardly to a base 26 at which
the outside diameter of the catheter remains substantially constant
along the central body portion 28 until the proximal end section 30
of the plastic catheter is reached. The proximal end portion 30 may
comprise a tapered opening metal or plastic hub 32 and a sleeve 34
which are suitably fastened such as by heat fusion or cementing to
the body portion 28 of the catheter. Alternatively, the proximal
end portion 30 may constitute a funnel end connector formed
integrally with the plastic catheter body portion 28 or the hub 32
may be molded plastic to which the body portion is cemented or
welded by a butt or shiplap joint.
The extent of tapering of the catheter tip in terms of taper angle
or distance may be varied. However, most satisfactory results in
use of the catheter assemblies are obtained if, in conjunction with
trocar tip dimension relationships as discussed above, the distance
from the tip 24 of the catheter to the base 26 of the tip tapering
is greater than the diameter of the catheter lumen 34.
The catheter tip 24 includes an integral convex constriction 36
which extends radially inward on the catheter tip. The convexity of
this constriction 36 is preferably complementary to the concavity
of the groove 20 so that there is a mating of the constriction 36
with the groove 20 when the catheter assembly is arranged as shown
in FIGS. 1 and 2 in preparation for intravascular positioning in a
patient. This mating relationship between the trocar 4 and the
catheter 6 permits smooth intravascular entry of the catheter upon
piercing of the vascular wall by the trocar and catheter assembly.
Accordingly, such construction serves to reduce phlebitis,
subcutaneous hematomas or similar undesired occurrences which may
produce discomfort or other undesired reactions to the patient.
Although the trocar 4 is advantageously made entirely of metal, or
with at least the tubular body and tip being formed of metal, the
trocar or stylet can be formed of suitable rigid plastic material.
Also, although the plastic catheter 6, and especially the proximal
end portion 22 and main body portion 28 are formed of plasticized
polyvinyl chloride, other flexible or semirigid plastic materials
may be used for this purpose. The proximal end portion of the
catheter 6 which comprises the connector means for connecting the
catheter to a fluid conveying tube if required in the use of the
device, may be formed integrally as an enlarged funnel end from the
same plastic material used to construct the tubular body portion 28
or of different plastic material as well as metal. The construction
of the catheter tip portion with the tapered section 22 and the
convex constriction 36 may be attained in several ways. For
example, the catheter 6 may be entirely molded such as injection
molding from suitable plastic material. Alternatively, the main
body portion 28 may be cut from extruded tubing, the tapering 22
may be ground or cut onto the end of the tube and the rounded tip
24 and convex constriction 36 may be attained by heat and pressure
molding, by controlled flame polishing or other suitable plastic
fabrication techniques known to the art.
Instead of the arrangement of a complementary bead 36 on the
catheter, alternative constructions may be used to obtain the
required blending of the catheter tip to the trocar exterior wall.
One of these is illustrated in FIGS. 4-8. In this embodiment,
instead of a semicircular groove in the trocar 40, which may be a
heavy wall hypodermic needle or a solid stylet, an undercut 42 is
ground or milled into the exterior wall 44 adjacent the angled tip
46. The catheter 48, in turn, is formed of a plastic cannula 50
with an inside diameter or lumen 52 of proper size to make a snug
slide fit on the wall 44 of the trocar 40. A hub 54 of molded
plastic with a female Luer tapered proximal opening 56 is fixed to
the cannula 50 such as by solvent or heat welding, cementing or
mechanically locked in the forward collar 58 of the hub.
The distal end 60 of the cannula 50 is molded or ground to a
rounded or tapered tip 62 before the catheter 48 is assembled on
the trocar 40. Just before such assembly, the distal end portion 60
of the cannula 50 is soaked in a volatile organic liquid which
dilates the plastic of which the cannula is formed and leaches out
plasticizer. For example, the cannula may be formed of polyvinyl
chloride plasticized with dioctyl phthalate and ethyl acetate may
be used as the leaching liquid. While the cannula tip is still in
the dilated condition, it is slid over the trocar into position as
shown in FIGS. 4 and 8. The plastic shrinks as the organic liquid
evaporates. The resulting configuration of cannula tip 62 and
trocar undercut 42 after the plastic is shrunk is shown in FIG. 8.
The portion of the plastic which has been soaked in the organic
solvent acquires a harder Durometer in the process because of
leaching of plasticizer. This increase in rigidity helps the
cannula tip to hold better in the undercut 42. This, in turn, helps
to prevent "push back" of the cannula as the assembly is inserted
through the vascular wall of a patient. Also, the resulting
geometry of the shrunk cannula tip and trocar end, permits the
catheter insertion to be accomplished without venous
thrombosis.
Another way of blending the catheter distal end tip to the trocar
wall is illustrated in FIG. 9. In this embodiment, the exterior
wall 64 of the trocar 66 has the distal end portion 68 roughened,
such as by sandblasting, centerless grinding, chemical etching,
electrolytic etching or the like. The distal end portion 70, with
the tapered tip 72 of the cannula 74 is dilated with volatile
organic liquid and then placed upon the trocar so the dilated
portion 70 overlays the roughened trocar surface 68. When the
dilating liquid evaporates, the cannula end portion 70 and tip 72
shrink around the trocar and create a firm blending of the cannula
tip to the trocar. This creates good holding and prevents push back
of the flexible cannula on the trocar which the skin and vascular
wall of the patient are pierced upon insertion of the catheter
assembly.
Yet another modification is shown in FIG. 10. Here, the wall 76 of
the trocar 78 is scored with a plurality of shallow circumferential
grooves 80 by milling, cutting, pressing or the like. The cannula
distal end portion 82 and tapered tip 84 are dilated with volatile
organic liquid before assembly of the parts. Upon evaporation of
the liquid, a blending of the distal end with the trocar wall is
obtained simultaneously with an increase in rigidity of the cannula
in the end portion.
In any of the embodiments described, the distal tip or any other
portions of the catheters may be provided with X-ray opaque
features to permit the position of the catheter or parts thereof,
should they break off in use, to be determined in the body of the
patient by X-ray observation, e.g., with photographic plate of
fluoroscope.
In accordance with practice which is now standard in the marketing
of intravascular catheters, the new catheter assemblies as
described and shown will preferably be placed in a functional
container or package and suitably sterilized such as exposure to
ethylene oxide vapors, gamma radiations or the like. In such a
packaged unit, the catheter assembly will preferably include a
small plastic plug (not shown) inserted into the proximal end
opening of the trocar connector to maintain sterility within the
trocar bore and seal the bore against egress of blood or other
vascular fluids until the exact moment for opening of the trocar
bore as desired by the physician, nurse or other party using the
catheter assembly upon a patient.
The use of the new catheter assemblies as described above follows
general practice which has been developed for use of related
devices known heretofore. With reference to the embodiment of FIG.
1, the sharpened end 8 of the trocar 4 is used to pierce the
vascular wall of a patient to create an opening therethrough. As
the assembly penetrates the vascular wall, the plastic catheter 6
enters the vascular channel along with the trocar 4. At this point,
if special procedures require it, the vascular fluid may be
withdrawn through the trocar bore 18 out the connector end 16, or
fluids may be introduced through the same channel. However, normal
use of the catheter assembly involves withdrawing the trocar 4 from
the assembly. This is attained by holding the plastic catheter 6
immobile relative to the patient by grasping the catheter connector
end 32 and pulling the trocar out through the catheter 6 by pulling
on the trocar connector end 16. At this point, an infusion tube
(not shown) or other suitable device is connected to the catheter
at the connector end 32 and any necessary infusion flow into the
vascular channel into which the catheter 6 has been placed may
begin. Adhesive tape, or similar arrangements known to the art may
be used to ensure retention of the catheter 6 in the patient
safeguarding against possible accidental dislodgment through normal
movement of the patient.
Not only does the unique structural arrangement between the blended
trocar and special ended catheter as described provide for smooth
intravascular entry of the catheter, but the rounded tip and
hardened arrangement on the end of the catheter serves to reduce
irritation to the internal walls of the vascular channel. This in
turn serves to substantially reduce occurrence of phlebitis in
patients in which intravascular catheters have been positioned.
* * * * *