U.S. patent number 3,841,308 [Application Number 05/406,605] was granted by the patent office on 1974-10-15 for distally valved catheter device.
This patent grant is currently assigned to Medical Evaluation Devices & Instruments Corp.. Invention is credited to Thomas E. Tate.
United States Patent |
3,841,308 |
Tate |
October 15, 1974 |
DISTALLY VALVED CATHETER DEVICE
Abstract
The disclosure is that of an invention directed to spring
guides, catheters, combined guide-catheters or intra-venous feeding
tubes in which the distal end is provided with a normally-open
proximally-controlled flow shut off valve. The valve is formed as a
helically wound spring distal extension with the coils normally
separated to define passages for fluid flow therebetween and a
proximally operated wire stylette is used to axially contract the
spring extension so that the coils thereof are brought into mutual
contact, thus closing the passages therebetween.
Inventors: |
Tate; Thomas E. (New Hyde Park,
NY) |
Assignee: |
Medical Evaluation Devices &
Instruments Corp. (Gloversville, NY)
|
Family
ID: |
23608720 |
Appl.
No.: |
05/406,605 |
Filed: |
October 15, 1973 |
Current U.S.
Class: |
600/585; 604/249;
604/528 |
Current CPC
Class: |
A61M
25/0075 (20130101); A61M 2025/0079 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61m 025/00 () |
Field of
Search: |
;128/2R,2M,2.5R,348,349R,35R,351,DIG.9 ;251/DIG.3 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Tate; Thomas E.
Claims
I claim:
1. A flexible catheter-like device, including a flexible inner
lumen-defining body having proximal and distal ends, a helically
would spring defining an open end distal extension of said inner
body and having proximal and distal ends, said distal extension
being formed with the coils thereof normally separated whereby to
provide normally open passages therebetween for fluid flow into or
out of the lumen of said inner body, said inner body being enclosed
within an outer smooth flexible sheathing, firmly bonded thereto
and formed from an inert plastic material, said sheathing extending
distally beyond the distal end of said inner body to define a
hollow tip for containing said spring-defined distal extension,
means for closing the distal end of said distal extension, and a
stylette passing through the lumen of said inner body and having
its distal end affixed to said distal end closing means and having
its proximal end extending proximally beyond the proximal end of
said inner body for proximally contracting said distal extension to
move the coils thereof into mutual contact, whereby to close the
normally open passages therebetween.
2. The device of claim 1 in which said inner body is formed from a
helically wound spring with the helices thereof in contact with
each other and in which said distal end extension is formed as a
continuation of said body spring.
3. The device of claim 1 in which the distally extending portion of
said outer sheathing is coextensive in length with the said distal
extension of said inner body and is firmly bonded to the separated
coils thereof, said distally extending portion of said outer
sheathing being provided with a plurality of radial apertures in
register with corresponding passages between said normally
separated coils.
4. The device of claim 1 in which the distally extending portion of
said outer sheathing has a length sufficient to define a cavity for
retaining said spring-defined distal extension when said distal
extension is proximally contracted to its mutual coil-contacting
condition, said distally extending portion of said outer sheathing
being unbonded to said spring-defined distal extension whereby to
permit the coils of said distal extension to partake of axial
movement relative thereto, said distal end closing means being
sealed to the distal coil of said distal end extension.
5. The device of claim 1 in which the distally extending portion of
said outer sheathing is coextensive in length with the said distal
extension of said inner body but is unbonded thereto whereby to
permit the coils of said distal extension to partake of axial
movement relative thereto, said distally extending portion of said
outer sheathing being provided with a plurality of radial apertures
in register with corresponding passages between said normally
separated coils, said distal end closing means being sealed to the
distal coil of said distal end extension.
6. The device of claim 1 in which the distally extending portion of
said outer sheathing is coextensive in length with the said distal
extension of said inner body, but is unbonded thereto whereby to
permit the coils of said distal extension to partake of axial
movement relative thereto, said distally extending portion of said
outer sheathing being provided with a plurality of radial apertures
in register with corresponding passages between said normally
separated coils, said distal end closing means being located
distally of the distal end of said distal end extension and being
axially movable relative thereto, whereby to serve as a valve
supplementary to that defined by the coils of said distal end
extension.
7. The device of claim 6 in which the distally extending portion of
said outer sheathing additionally if provided with a distal
extension having a proximal end and a distal end portion, the
proximal end of said sheathing distal extension being necked down
to restrain said distal end spring extension against abnormal axial
elongation, said distal end portion of said sheathing extension
being configured to define a generally spherical cage for freely
retaining said distal end closing means therein.
8. The device of claim 1 additionally including means operably
associated with the proximal end thereof for releasably retaining
said stylette in a proximally retracted position such as to
maintain said distal spring extension in its proximally contracted
condition.
Description
THE INVENTION
This invention relates generally to new and useful improvements in
spring guides, catheters, combined guide-catheters or intravenous
feeding tubes of the types frequently used for relatively long time
retention within a vein or other vessel of an animate being and
particularly seeks to provide a novel such device in which the
distal end thereof includes a normally-open proximally-controlled
flow shut off valve.
Heretofore, in many types of diagnostic tests or subsequent
chemo-therapy treatments or intra-venous feedings it has been, and
still is, customary to employ percutaneous techniques for the
insertion of spring guides, catheters, combined guide-catherters or
intravenous feeding tubes and to withdraw same from the vessel
involved after each test or treatment stage has been completed,
because none of such devices have been provided with valves for
preventing back flow of fluids whenever the use thereof is to be
temporarily suspended or for permitting the internal cleaning of
such devices between test or treatment stages, even though through
the use of external inert coatings, such as those provided by the
group of polyfluroethylene compounds, they could otherwise be
permitted to remain in place during the interim periods without
damaging effects to the vessels involved.
However, in accordance with this invention such devices may be
provided with distal end shut off valves so constructed that the
initial insertion, retention and ultimate retraction of such
devices is not adversely affected, while still permitting the
valves to be operated at any desired time.
Therefore, an object of this invention is to provide a novel
lumen-containing catheter-like device for insertion into and
retention within a blood or other vessel of an animate being and
which is provided with a shut off valve at its distal end.
Another object of this invention is to provide a device of the
character stated in which the distal end thereof includes a
helically coiled spring of which the helices at the tip thereof are
normally separated whereby to permit fluid to flow either into or
out of the lumen therof and in which proximally actuated means are
provided for axially compacting the normally separated helical
coils into contact with each other whereby to shut off fluid flow
to or from the lumen.
Another object of this invention is to provide a device of the
character stated in which the distal end of the spring is
permanently closed and the closure thereof is affixed to the distal
end of an internal wire stylette, the proximal end of which extends
proximally beyond the proximal end of the entire device whereby to
permit proximal movement of the stylette to close the normally open
valve.
Another object of this invention is to provide a device of the
character stated in which at least the distally valved end thereof
is provided with a thin flexible inert sheathing surrounding and
bonded to the separated helices of the spring and having a
plurality of radial perforations or apertures aligned with the
spaces between the normally separated helices to permit free flow
of fluid into or out of the spring lumen and to be compactable when
the spring tip is proximally retracted into its closed valve
status.
Another object of this invention is to provide a device of the
character stated in which the inert sheathing thereof is
sufficiently thick as to be relatively non-axially compactable and
in which the distal end portion of the sheathing is not bonded to
the normally separated distal helices of the spring whereby to
permit the separated distal helices of the spring to partake of
axial movement relative to the sheath.
Another object of this invention is to provide a device of the
character stated in which the closure for the distal end of the
spring is axially movable relative thereto and is affixed to the
distal end of the wire stylette whereby to permit the closure
itself to serve as a valve supplementary to that provided by the
normally separated distal helices of the spring.
A further object of this invention is to provide a device of the
character stated in which the valve-forming helices of the distal
tip may be of progressively reduced radii whereby to form a
distally tapering tip.
A further object of this invention is to provide a device of the
character stated that is simple in design, rugged in contruction
and sufficiently economical to manufacture as to be disposable
after a single use, if desired.
With these and other objects, the nature of which will become
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 a somewhat schematic longitudinal section of the distal
end of a valved device constructed in accordance with this
invention and shows the valve thereof in its normally open
position;
FIG. 2 is a view similar to FIG. 1 but showing the valve in its
closed position;
FIG. 3 and 4 are similar to FIGS. 1 and 2 but showing a tapered
distal tip;
FIG. 5 is a schematic longitudinal section of a typical completed
device showing a fitting at the proximal end for control of the
stylette and for connection with an external fluid supply or
receiver.
FIGS. 6-8 show a modified construction that may be used when the
inert sheath of the spring is relatively thick and imperforate;
FIGS. 9 and 10 are comparable to FIGS. 6-8 but show a further
modification that may be used when the relatively thick inert
sheath of the spring is radially perforated or apertured;
FIGS. 11-13 show a further modification in which the closure for
the distal end of the spring is rigidly affixed to the distal end
of the wire stylette while being unattached to the distal end of
the spring; and
FIG. 14 is a further modification, based primarily upon FIGS.
11-13, and showing one manner of necking down the sheathing to
limit the distal elongation of the spring and to provide a distal
stop or abutment for the closure.
Referring to the drawings in detail the invention, as illustrated,
may be embodied in any diagnostic, surgical or treating device that
includes (see FIGS. 1 and 2) an elongated body generally indicated
5 preferably formed from a helically wound spring having its
proximal coils 6 in contact with each other and having its distal
coils 7 normally separated to function as a valve-forming
compression spring distal extension of the body.
The distal tip of the separated coils 7 is sealed by a solid
closure 8 welded or otherwise permanently affixed thereto and a
flexible wire sytlette 9 extends through the lumen of the spring
body 5 and has its distal end affixed to the closure 8 and is
sufficiently long that its proximal end projects proximally beyond
the proximal end of the spring body 5 so that tension can be
applied thereto when desired in order to axially compact the coils
7 into mutual contact, thus shutting off any fluid flow
therebetween into or out of the body lumen. Obviously, release of
tension on the stylette 9 will permit the coils 7 to again separate
for resumption of fluid flow therebetween.
Recongnizing that such devices generally require the use of an
inert smooth outer coating or sheathing such as that provided by a
polyfluoroethylene compound, a thin flexible coating or sheathing
10 is applied to the full length of the device and is provided at
its distal end with a plurality of radial slots or apertures 11
(see FIG. 1) aligned with the spaces between the normally separated
coils 7. When tension is applied to the stylette 9 to close the
valve tip, the coating 10 simply compacts into bellows-folds or
pleats without preventing the spring coils 7 from being brought
into mutual contact for valve closing purposes.
FIGS. 3 and 4 show a modification by which the principles of this
invention may be applied to tapered distal tip if desired. Here,
the normally separated coils 7 are of progressively decreasing
radii in order to provide the desired taper and preferably the
varying radii should be such as to permit the successive coils to
become seated one upon another when the valve is in its closed
position as indicated in FIG. 4.
However, if for any reason it should be desired to have the valve
substantially flat in its closed position, the progressively
decreasing radii of the coils 7 can be reduced further so that the
coils can become nested in radial contact within a single plane,
rather than becoming seated one upon another as in FIG. 4.
FIG. 5 shows a typical complete device in which the proximal end is
provided with a fitting 12 having an angled fluid connector 13 and
a proximal end 14 through which the proximal end of the stylette 9
passes for adjustable positioning as by a clamp 15.
Although it is believed that the nature of this invention will have
become fully understood from the foregoing description, certain
modifications thereof may be employed in the event that the
sheathing or coating 10 should be too thick to permit its axial
compaction by manipulation of the stylette 9.
For example, FIGS. 6-8 show a modification in which an imperforate
relatively thick sheathing or coating 16 is bonded to the proximal
coils 6 but is not bonded to the normally separated distal coils 7
so that the distal coils may partake of axial sliding movement
within the distal end portion of the sheathing 16. FIG. 6 shows the
normally open status of the distal end parts; FIG. 7 shows the
distal end valve as it would be closed during insertion into a
vessel; and FIG. 8 shows the distal end valve in a wider open
position that may be achieved during retention in the vessel by
pushing the stylette in a distal direction beyond the position
normally achieved solely by the natural spring expansion of the
distal coils 7. The distal end valve may of course be closed at any
time to the condition shown in FIG. 7 by proximal manipulation of
the stylette 9. In this modification fluid flows into or out of the
lumen of the device through the passages between the distal coils 7
whenever those coils are in their separated condition and project
beyond the distal end of the sheathing.
As a further example of such maodifications, FIGS. 9 and 10
illustrate a different structure in which, as in the case of FIGS.
6-18, the sheathing or coating 16 is relatively thick but entirely
surrounds the full length of the normally separated distal coils 7.
Here, the sheathing 16 is provided with a plurality of radial slots
or apertures 17 through which fluid flow into or out of the lumen
of the device may occur, depending upon the open or closed
condition of the distal end valve.
The normal condition of the distal end elements is shown in FIG. 9
in which the valve-forming portions thereof are open and the
closure 8 forms a sliding seal at the distal end of the sheath 16.
FIG. 10 illustrates the relative positions of the parts when the
distal end valve is closed.
A further modification of that illustrated in FIGS. 9 and 10 is
shown in FIGS. 11-13. Here, the closure element 8, while still
being affixed to the distal end of the stylette 9, is free from
attachment to the distal end of the coils 7 so that it may partake
of relative motion with respect thereto and serve as a valve
supplemental to that defined by the normally separated distal coils
7.
Thus, FIG. 11 shows the normal condition of the device with the
normally separated valve-forming distal coils 7 retained within the
distal end portion of the sheathing 16 and the closure 8 seated on
the coils at the distal end of the sheathing. In this condition
fluid flow may occur into or out of the lumen of the device through
the sheath apertures 17 and the passages between the coils 7.
Additional flow capacity may be provided, as shown in FIG. 12, by
distally advancing the closure 8. FIG. 13 shows the valve of this
modification in its closed position, which essentially is the same
as in FIG. 10.
It also should be mentioned that the supplemental valve function of
the closure 8 as shown in FIGS. 11-13 can readily be adapted to a
sole direct or primary valve function simply by eliminating the
valve-forming distal end spring coils 7 and having the closure
seatable upon the distal end of the proximal coils 6. In such event
the sheathing would be imperforate and the normal configuration
would be somewhat similar to that shown in FIG. 7 and the open
valve configuration would be somewaht similar to that shown in FIG.
12.
FIG. 14 shows a further modification, similar to that shown in
FIGS. 11-13, in which the sheathing 16 may be necked down as at 18
to provide an abutment for preventing abnormal axial elongation of
the distal coils 7 and in which the sheathing 16 may be extended
beyond the distal end of the coils 7 to define a generally
spherical retention cage 19 for the closure 8 which thus still can
perform its supplemental valve function while still being
restrained from axial movement beyond the distal tip of the
sheathing extension.
A further modification (not shown) could be a variation of that
shown in FIGS. 9 and 10. Here, the normally separated coils 7 would
be interposed between the mutually contacting body coils 6 and a
similarly coiled body distal tip, so that the similarly coiled
distal tip, in effect, could serve as a sliding plug within the
sheathing 16. Of course, in such a further modification the radial
apertures 17 would be relatively relocated in order still to
register with the spaces between the separated coils 7.
The principles of this invention are equally applicable to those
currently used types of intravenous feeding tubes or catheters
formed from plastic tubing, in which event it is only necessary to
fit the distal end thereof with a normally open coiled spring valve
as heretofore described and to include a proximally controlled
sytlette within the lumen.
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.
* * * * *