U.S. patent number 3,757,768 [Application Number 05/241,915] was granted by the patent office on 1973-09-11 for manipulable spring guide-catheter and tube for intravenous feeding.
Invention is credited to William M. Kline.
United States Patent |
3,757,768 |
Kline |
September 11, 1973 |
**Please see images for:
( Certificate of Correction ) ** |
MANIPULABLE SPRING GUIDE-CATHETER AND TUBE FOR INTRAVENOUS
FEEDING
Abstract
This invention is directed to a manipulable, flexible, unitary,
combined spring guide-catheter that includes an inner wall portion
formed as a continuous helical spring with the helices in contact
with each other and an outer wall portion formed from an inert
plastic material enclosing the spring in such a manner as to become
firmly bonded to the spring while having its outer surface smooth.
The distal end of the outer wall extends beyond that of the inner
wall to define a hollow tip that is provided with axial and/or
radial perforations. A wire stylette is freely carried within the
lumen of the inner wall; and the stylette and the spring
guide-catheter are separately manipulable by suitable handles
attached to the respective proximal ends thereof. A shorter length
guide-catheter of this same construction, but without the wire
stylette, may be used to replace the rigid tubes heretofore used
for intra-venous feeding.
Inventors: |
Kline; William M.
(Gloversville, NY) |
Family
ID: |
22912692 |
Appl.
No.: |
05/241,915 |
Filed: |
April 7, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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218224 |
Jan 17, 1972 |
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Current U.S.
Class: |
600/434;
604/95.01 |
Current CPC
Class: |
A61M
25/09041 (20130101); A61M 25/09025 (20130101); A61M
25/0662 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348-351,343,356,33R,2M,2.5R,DIG.9,214.4 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
US.C.I. Catalogue, 1967, pg. 41.
|
Primary Examiner: Truluck; Dalton L.
Parent Case Text
RELATED APPLICATION
This application is a continuation-in-part of my co-pending
application Ser. No. 218,224, filed Jan. 17, 1972 (now abandoned),
under the title "Manipulable Combined Spring Guide and Catheter".
Claims
I claim:
1. A flexible spring guide-catheter including an inner wall portion
having proximal and distal ends and formed from stainless steel
wire as a continuously wound lumen-defining helical spring with the
helices thereof in contact with each other, and an uninterrupted
externally smooth outer wall portion having proximal and distal
ends and formed from an inert halogenated hydrocarbon so applied
around said helical spring that its inner surface is firmly bonded
thereto and its outer surface remains smooth, the distal end of
said outer wall portion extending beyond the distal end of said
inner wall portion and shaped to define a hollow tip, said hollow
tip being provided with at least one perforation to effect open
communication between the exterior and interior thereof, the
proximal end of said hollow tip being closely engaged around the
distal end of said inner wall portion whereby to prevent the said
distal end of said inner wall portion from becoming axially
elongated (the proximal portion of exterior and interior
thereof).
2. The spring guide-catheter of claim 1 in which said hollow tip is
preformed into a curvilinear shape.
3. The spring guide-catheter of claim 1 additionally including a
wire stylette freely movable into and out of the lumen of said
inner wall portion, and having a length such that when fully
inserted into said spring guide-catheter the proximal end of said
wire stylette extends proximally beyond the proximal end of said
spring guide-catheter a distance sufficient to permit its
manipulation from such proximal location, at least the distal end
portion of said wire stylette being preformed into a curvilinear
shape.
4. The spring guide-catheter of claim 1 additionally including; a
wire stylette freely movable within the lumen of said inner wall
portion and having a length such that when fully inserted into said
spring guide-catheter the proximal end of said wire stylette
extends proximally beyond the proximal end of said spring
guide-catheter a distance sufficient to permit its manipulation
from such proximal location; a first manipulative handle provided
with an axial bore to permit free passage of said wire stylette
therethrough and removably attached to the proximal end of said
spring guide-catheter; and a separate manipulative handle removably
attached to the proximal end of said wire stylette proximally of
said first manipulative handle.
5. The construction of claim 1 having a length of from about 2.5 to
about 10.0 cm. whereby to be capable without physical change for
use as a tube for intravenous feeding purposes, and additionally
including a fitting rigidly affixed to the proximal end thereof for
operative connection to a liquid supply source.
6. The spring guide-catheter of claim 5 wherein said outer wall
portion terminates at the distal end of said inner wall
portion.
7. The intra-venous feeding tube of claim 5 wherein the distal end
of said outer wall portion is cut off at an angle distally of said
inner wall portion.
Description
THE INVENTION
This invention is generally directed to new and useful improvements
in those types of spring guides and catheters that are used for the
catheterization of the heart and/or internal vessels of the body
during certain diagnostic testing and treating procedures and
particularly seeks to provide a novel, unitary, manipulable,
combined spring guide and catheter for such purposes.
Although catheters of various constructions and materials have long
been known, it has been only relatively recently that catheters and
devices for controlling them have been developed to permit their
generally successful use in techniques such as those required for
coronary arteriography or aortography by percutaneous
catheterization.
Currently, such techniques generally require the percutaneous
insertion of a sharpened cannula into the lumen of a vein or other
vessel, after which a wire guide is inserted through the cannula
and advanced through the curvatures of the vessel(s), under
fluoroscopic observation, until the distal tip of the guide has
reached the position at which the injection of a liquid contrast
material, or pressure or other readings taken, in order to commence
the diagnostic test or chemo-therapy treatment. After the wire
guide has been thus advanced to its then ultimate position, a
catheter is inserted thereover and advanced to the point at which
its distal end coincides with or extends beyond the distal end of
the wire guide. At this stage, the wire guide must be withdrawn in
order to allow sufficient volume within the lumen of the catheter
to permit the required rate of flow of the injected contrast medium
to take place or to permit the taking of pressure or other
measurements without the throttling or other effects that may be
caused by the presence of the wire guide.
Obviously, such catheterizations are very delicate in nature,
requiring manipulative techniques that avoid such problems as the
inadvertant perforation of the wall of a vessel, breaking or
kinking of the guide due to its mishandling during advance through
the curvatures or convolutions of the vessel's lumen, or comparable
problems in advancing the catheter over the wire guide. Still
further complications can arise during or as a consequence of
withdrawing the wire guide in the event that its withdrawal or
retraction is improperly effected.
More recently, such problems have been somewhat reduced through the
use of guides formed as closely wound helical springs that are more
capable of following the various curvilinear paths of the vessel's
lumen; and still more recently, these latter types of wire guides
have been constructed to permit the manipulation of their distal
ends by devices located at their proximal ends.
Even so, it is still necessary to withdraw the wire guide after the
catheter has been advanced into place thereover.
However, a combined spring guide and catheter constructed in
accordance with this invention overcomes the problems heretofore
present in such catheterization procedures and does not require the
separate and successive use of a wire guide followed by a catheter,
and in a shorter length can be used as a tube for intra-venous
feeding.
Therefore, an object of this invention is to provide a novel
manipulable unitary spring guide and catheter that can be ued in
place of the heretofore used separate spring guides and used
Another object of this invention is to provide a spring
guide-catheter of the character stated that is of tubular
construction and includes an inner wall portion formed from a
continuous helically wound metal spring with the helices thereof in
contact with each other and an outer wall portion or sheath formed
from an inert plastic material that is shrunk fit over the coils of
said inner wall portion.
Another object of this invention is to provide a spring
guide-catheter of the character stated in which the distal end of
said outer wall portion extends distally beyond the distal end of
said spring-defined inner wall portion and is provided with at
least one perforation whereby to define a distal tip for open
communication with the adjacent portion of the vessel into which
said spring guide-catheter has been inserted.
Another object of this invention is to provide a spring
guide-catheter of the character stated into which a pre-configured
wire stylette may be freely inserted and withdrawn before, during
or after insertion of the spring guide-catheter into a body vessel,
whereby to assist the guidance or positioning of at least the
distal end of the spring guide-catheter.
Another object of this invention is to provide a spring
guide-catheter of the character stated in which detachable means
are provided for torsionally rotating or oscillating the spring
guide-catheter and for advancing, retracting or rotating or
oscillating the freely movable wire stylette.
A further object of this invention is to provide a spring
guide-catheter of the character stated which is so constructed that
its lumen capacity for any given outside diameter is greater than
that heretofore available in prior known catheters of corresponding
external diameters.
A further object of this invention is to provide a spring
guide-catheter of the character stated in which the distal end of
the outer wall portion or sheath may be preformed into any desired
curvilinear shape.
A further object of this invention is to provide a spring
guide-catheter of the character stated in which the material of the
spring inner wall is sufficiently radiopaque as to eliminate the
need for any additional radiopaque material in order to permit
fluoroscopic observation of the guide-catheter as it is advanced,
manipulated or retracted.
A further object of this invention is to provide a spring
guide-catheter of the character stated in which the outer wall
portion is sufficiently strong and well bonded to the spring inner
wall portion as to safely contain the spring in the event that it
should become broken due to any overviolent mishandling by an
operator or to fatigue that may occur through overuse.
A further object of this invention is to provide a guide-catheter
of the character stated that, if produced in short lengths and
without the wire stylette, can be used as an insertable tube for
intra-venous feeding purposes.
A further object of this invention is to provide a spring
guide-catheter of the character stated that is simple in design,
rugged in construction and economical to manufacture.
With these and other objects, the nature of which will be apparent,
the invention will be more fully understood by reference to the
drawings, the accompanying detailed description and the appended
claims.
In the drawings:
FIG. 1 is an enlarged longitudinal section of a spring
guide-catheter constructed in accordance with this invention and
shows a straight tip having a single axial perforation at its
distal end;
FIG. 2 is an enlarged longitudinal section of the distal end of the
spring guide-catheter in which the tip is preformed into a
curvilinear shape and is provided with a plurality of lateral
perforations;
FIG. 3 is an enlarged detail elevation of the distal end of a
control wire stylette that has been preformed into a
J-configuration;
FIG. 4 is a view similar to FIG. 3 but showing the wire stylette
preformed as a long pitch spiral;
FIG. 5 is an enlarged fragmentary longitudinal section of the
proximal end of the spring guide-catheter when attached to typical
manipulating handles or devices;
FIG. 6 is a view similar to FIG. 1, but showing a modification of
the spring guide-catheter, without the wire stylette, for use as an
intra-venous feeding tube;
FIG. 7 is a fragmentary longitudinal section of the distal end of
the tube of FIG. 6, but showing its tip biased or cut at an angle;
and
FIG. 8 is a fragmentary longitudinal section of or modification of
the distal end of the tube of FIG. 6 in which the distally
extending hollow tip has been eliminated.
Referring to the drawings in detail the invention, as illustrated,
is embodied in a spring guide-catheter generally indicated 5 that
may be made in any required length, for example, from 20 cm. to 150
cm. or more, and of a size ranging from a No. 2 to a No. 10
French.
The spring guide-catheter 5 includes an inner wall portion 6
defined by a continuous helical spring wound with the helices
thereof in contact with each other and formed from stainless steel
spring wire, and an outer portion 7 formed from a tube of smooth,
inert, flexible plastic material, such as a halogenated
hydrocarbon, that is shrunk-fit, as by heat, over the inner wall
portion 6 in such a manner that the outer surface of the plastic
tube remains smooth and its inner surface is forced into the spiral
grooves on the outer surface of the inner wall portion 6, thus
effecting a firm bond between the outer tube and the inner
spring.
The tubular outer wall portion 7 extends beyond the distal end of
the inner wall portion 6 to define a distally extending straight
tip 8 (see FIG. 1) provided at its distal end with an axial
perforation 9 to permit open communication between the lumen of the
spring guide-catheter 5 and the lumen of the vessel into which the
spring guide-catheter is inserted.
Shrinkage of the plastic tube from which the outer wall portion 7
is formed causes a natural slight necking down of the tip 8, as at
10, which locks the distal end of the inner wall spring against
axial elongation and also provides a smaller outside diameter for
the tip which enhances its advance through a vessel or into a
branch thereof.
FIG. 2 of the drawings shows a modification of the distal end of
the spring guide-catheter in which the tip 8 thereof is preformed,
as by heat-setting, into a curved shape and the axial perforation 9
is replaced by a plurality of lateral or radial perforations
11.
A stylette wire 12, for assisting in the manipulation and control
of the spring guide-catheter as it is being advanced into or
withdrawn from a vessel, fits freely within the lumen 13 of the
spring guide-catheter and is freely movable axially with respect
thereto. The stylette wire 12 may be straight as shown in FIG. 1;
may have a preformed J-shape 14 at its distal end as shown in FIG.
3; or may have all or a portion of its length formed as a
long-pitch spiral 15 as shown in FIG. 4. In any event, the specific
configuration or curvature of the wire stylette will be that which
has been determined, from manipulative experience, to be the most
desirable to enable the spring guide-catheter to be most easily
used for the type of catheterization involved.
In use, and common to prior techniques, a sharpened hollow needle
or cannulus is first used to gain percutaneous entry to the lumen
of a vessel to be catheterized, after which the spring
guide-catheter of this invention is employed for the actual
catheterization.
At this stage, due to the unitary construction and proportions of
this spring guide-catheter, only the single passage of a single
device along the lumen of the vessel to be catheterized is
required.
By contrast, all prior known techniques have at least required;
firstly, the introduction and advance of an independent spring
guide to its ultimate position within the lumen of a vessel;
secondly, the insertion of a catheter over the previously inserted
spring guide with the consequent further abrasion or frictional
contact with the walls of the vessel's lumen and a further dilation
thereof due to the added thickness of the catheter; and thirdly a
complete retraction or withdrawal of the initially implanted spring
guide in order to provide sufficient volumetric capacity within the
lumen of the implanted catheter to permit the proper infusion of a
contrast medium through the catheter or to permit the unobstructed
or unthrottled taking of pressure or other measurements
therethrough.
Here, even if the stylette wire 12 should be retained within the
lumen of the spring guide-catheter 5, there is still sufficient
capacity within the lumen to permit proper infusion of a contrast
medium under the required pressure or to permit the taking of
pressure or other measurements, although such functions would be
enhanced if the wire stylette were completely retracted or
withdrawn before any such functions are commenced.
It should be pointed out that the fully bonded inner-to-outer wall
construction of the spring guide-catheter of this invention enables
it to withstand any normally used pressures for the introduction
and dispersion of a contrast medium through the distal tip and that
the tip itself has a wall strength to withstand such pressures,
even though there is a pressure drop in the tip due to the release
or discharge of the contrast medium through the perforations
thereof.
Manipulation of the spring guide-catheter 5 by torsion in either
direction and its advance or retraction within the lumen of a
vessel is effected by a handle generally indicated 16 which is
removably attached to the proximal end of the spring guide-catheter
and provided with an axial bore 17 which initially permits passage
of the wire stylette 12 therethrough and subsequently serves as a
duct for transmission of the contrast medium or the taking of
pressure measurements after the stylette has been fully withdrawn
therefrom.
The stylette 12 is manipulated axially and torsionally relative to
the spring guide-catheter as the spring guide-catheter is being
advanced to assist in the proper directioning thereof during
advance. For this purpose, a handle or knob generally indicated 18
is removably attached to the proximal end of the stylette.
It will have become evident from the description thus far, that
since only a single device, namely the combined spring
guide-catheter of this invention, is required for catheterization
in a single pass into a vessel, the time required to effect the
fully-controlled catheterization is greatly reduced in comparison
with that required by prior known techniques using separate and
sequentially inserted spring guides and catheters.
Furthermore, the spring guide-catheter of this invention is so
proportioned and constructed that it can be used for the controlled
catheterization of smaller diameter vessels than heretofore
possible while retaining an adequate capacity for the transmission
of a contrast medium therethrough at any desired flow rate and
pressure normally used.
For example, it is believed that no prior known sequentially used
spring guides and catheters could effectively catheterize vessels
having lumens smaller than about 0.72 inch I.D. (inside diameter),
since a French No. 5 catheter, having an O.D. (outside diameter) of
about 0.65 inch is the smallest that could be used for such a
vessel while providing sufficient volume capacity within the
catheter lumen to properly transmit a contrast medium under the
flow rates and pressures required.
In contrast, a spring guide-catheter constructed in accordance with
this invention can be fabricated down to a No. 2 or No. 3 French
size (O.D. 0.035 - 0.045 inch) and still have adequate lumen
capacity for the transmission of a contrast medium, under the
desired flow rates and pressures, without danger of blow out
through the walls or of whiplash of the distal end due to reaction
from the release or emission of the contrast medium through the
perforation(s) of the tip thereof.
As a corrolary, it should also be noted that, on a size-for-size
basis, the spring guide-catheter of this invention has a delivery
capacity of from about 1.5 to about 1.75 times greater than that of
prior catheters per se usable for the same purposes.
Where the tip 8 is provided with the single distal axial
perforation 9, as shown in FIG. 1, it has been observed that the
discharge of a contrast medium therethrough takes place in a
whirling manner about the axis of delivery, thus assuring complete
and immediate contact of the contrast medium with all of the
adjacent wall portions of the vessel's lumen.
If the length of the tip 8 should extend sufficiently beyond the
distal end of the radiopaque spring inner wall 6 that additional
radiopaqueness of the tip is required, such can be accomplished by
treating all or part of the tip with a supplemental radiopaque
material that either is incorporated therein or is separately
applied and firmly bonded thereto.
As previously indicated in the objects of this invention and as
illustrated in FIGS. 6-8 of the drawings, this spring
guide-catheter may be readily modified by reducing its length to
from about 2.5-10.0 cm. and by eliminating the wire stylette 12 in
order to adapt it for use as a flexible intra-venous feeding tube
to replace the heretofore used normally rigid I.V. tubes or hollow
needles.
It is believed that, originally, such I.V. tubes were made of a
frangible material such as glass, with consequent risks of injury
to the patient due to breaking of the tube during or after
insertion thereof into a vein or to movements of the patient that
would cause discomfort, breaking of the tube or even perforation of
the vein wall; or, more recently, were made of a vinyl or other
relatively rigid plastic material that eliminated only the breakage
problem while introducing the new problem of flow stoppage or
reduction due to wall collapse or kinking resulting from a
patient's movements.
Such problems, too, are solved through the use of guide-catheter
tubes constructed in accordance with this invention since these
tubes (1) are not frangible; (2) are strong enough to withstand
substantial flexing without being subject to wall collapse or
kinking; and (3) are sufficiently flexible as to minimize patient
discomfort during movements while at the same time adapting to such
patient movements without danger of causing perforation of the vein
walls.
For this purpose (see FIG. 6) the guide-catheter 5 still comprises
the spring inner wall portion 6, the plastic outer wall portion 7
and the distal tip 8 extending from the necked-down portion 10.
However, the distal end of the tip 8 is shorter than that shown in
FIG. 1 and is open as at 19 to permit a free flow of the I.V.
liquid therethrough; and the handle 16 (shown in FIG. 5) at the
proximal end of the guide-catheter 5 is replaced by a female Luer
or other suitable fitting 20 for connection with the discharge from
the I.V. supply.
Naturally, the lumen capacity of this modification of the
guide-catheter will be such as to permit the required flow rate of
the I.V. fluid while its outside diameter is small enough to permit
its ready insertion into the patient's vein.
Although it is believed desirable in this modification to retain
the shortened distal tip 8, since its somewhat smaller diameter
enhances the ease of insertion of the I.V. tube into a vein, some
technicians may feel that it produces an unnecessary constriction
at the distal end. In such cases the tip 8 may be eliminated by
terminating the outer wall portion 7 at the distal end of the inner
wall portion 6 (see FIG. 8), where its natural tendency to
neck-down will simply form a smooth bead 21 at the distal end which
still will restrain the inner wall portion 6 against axial
elongation.
The distal end of the tip 8 may also be biased or cut off at an
angle as shown at 22 in FIG. 7 of the drawings.
For either catheterization of I.V. feeding purposes, percutaneous
access to the vein or vessel involved may be gained through the use
of a sharpened split cannula or needle through which the
guide-catheter or I.V. tube is inserted and which is removed from
the patient immediately thereafter.
Whenever the guide-catheter or I.V. tube must remain in place for a
substantial length of time, its proximal end may be removably
fastened to the patient's skin by adhesive tape, but more
preferably through the use of a two part multiple hook fabric
fastener, such as that currently available under the trademark
"Velcro", in which one part is carried by the proximal end of the
tube or guide-catheter and the other part is carried by the exposed
surface of a strap or adhesive strip removably fastened to the
patient.
It should be further mentioned that, due to the relative low cost
of fabrication, the spring guide-catheter of this invention
normally will be disposed or discarded after a single use, even
though its materials and construction are such that it is capable
of being used a plurality of times before being discarded, assuming
that it would be properly autoclaved for cleanliness and sterility
between uses.
It is of course to be understood that variations in arrangements
and proportions of parts may be made within the scope of the
appended claims.
* * * * *