U.S. patent number 3,599,620 [Application Number 04/852,974] was granted by the patent office on 1971-08-17 for resilient reservoir assembly.
This patent grant is currently assigned to The Kendall Company. Invention is credited to Jay Z. Balin.
United States Patent |
3,599,620 |
Balin |
August 17, 1971 |
RESILIENT RESERVOIR ASSEMBLY
Abstract
An inflatable retention catheter's resilient inflated reservoir
retaining a fluid under pressure is enclosed by a jacket which
reduces fluid loss through the reservoir wall during storage and
does not inhibit deflation of the reservoir.
Inventors: |
Balin; Jay Z. (Des Plaines,
IL) |
Assignee: |
The Kendall Company (Boston,
MA)
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Family
ID: |
25314692 |
Appl.
No.: |
04/852,974 |
Filed: |
August 18, 1969 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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508673 |
Nov 19, 1965 |
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Current U.S.
Class: |
604/98.01;
604/920 |
Current CPC
Class: |
A61M
25/1018 (20130101); A61M 25/10183 (20131105); A61M
25/10184 (20131105) |
Current International
Class: |
A61M
25/10 (20060101); A61m 025/00 () |
Field of
Search: |
;128/348,351,246,325,344 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Parent Case Text
This application is a continuation of Ser. No. 508,673 filed Nov.
19, 1965 and now abandoned.
Claims
I claim:
1. In combination, a self-inflatable bag catheter comprising an
elongated flexible thin-walled drainage tube open at its proximal
end and having at least one lateral opening in its distal end, a
thin-walled elastic sleeve adjacent the distal end of said drainage
tube, said sleeve being bonded along its marginal zones to the
exterior surface of said drainage tube to form a fluidtight seal
along said marginal zones of said sleeve and being unattached to
said drainage tube along its central region whereby the central
region of said sleeve is free to expand laterally of said drainage
tube upon the introduction of an inflating fluid into the space
formed between the unattached central region of the sleeve and the
exterior surface of the drainage tube adjacent thereto, a flexible
inflation tube opening at its distal end into the space formed
between the unattached central region of the said sleeve and the
exterior surface of the drainage tube adjacent the central region
of the said sleeve, the proximal end of said inflation tube
terminating in an elastic inflation arm offset from the proximal
end of said drainage tube including a resilient inflated reservoir
retaining a fluid under pressure, the natural shape of said
reservoir when unrestrained when inflated being prolate in which
the axis thereof which is parallel with the length of the inflation
arm is the major longitudinal axis, and a jacket enclosing the
inflated reservoir, said jacket restricting said inflated reservoir
to a shape other than a prolate shape with its longitudinal axis
parallel with the inflation arm and restraining the inflated
reservoir to a smaller longitudinal dimension than it would assume
inflated with the same amount of fluid when unrestrained so that
said axis of said reservoir which is parallel with the length of
the inflation arm is no greater than a major axis thereof
perpendicular thereto and the amount of fluid in the restrained and
restricted shaped inflated reservoir being the same as the amount
of fluid in the reservoir inflated when unrestrained and
unrestricted.
2. The catheter of claim 1 wherein a portion of the jacket interior
is spheroidally concave.
3. The catheter of claim 1 wherein the interior of the jacket is
predominantly spherically concave in which all axes passing through
the center thereof are substantially of equal length.
4. The catheter of claim 1 wherein the interior of the jacket is
predominantly oblately spheroidally concave in which the axis
thereof parallel to the length of the inflation arm is shorter than
an intersecting axis perpendicular thereto.
5. The catheter of claim 1 wherein the interior of the jacket is
predominantly prolately spheroidally concave in which its major
axis intersects the longitudinal axis of the inflation arm and is
perpendicular thereto.
6. The catheter of claim 1 wherein the interior surface of the
jacket is in sealing contact with the exterior surface of the
inflated reservoir throughout substantially its entire surface
area, the restrained and restricted shape of said inflated
reservoir being such that upon partial loss of fluid from the
reservoir and consequent deflation of the reservoir the total
surface contact between the jacket and reservoir is greater, for
the same amount of fluid loss, than the total surface contact
between a reservoir and enclosing jacket of a prolate shape
corresponding to the prolate shape the reservoir would have if
inflated when unrestrained.
Description
This invention relates to self-inflating catheters, that is, to
catheters which have a fluid distended elastic reservoir which upon
release of the contained fluid exerts sufficient pressure while
deflating to inflate an inflatable retention bulb or balloon near
the distal end of the catheter. More specifically, this invention
relates to means for reducing fluid loss from the reservoir through
its walls in storage and prior to use.
For purposes of this invention, the distal end of a catheter is
considered to be that end which is inserted into an animal body
whereas the proximal portion of the catheter is that portion which
is intended to be outside the body.
The reservoir of a self-inflating catheter is preferably kept as
small as possible to eliminate bulkiness but it is kept within size
limitations for other reasons. The retention bulb of an inflatable
bulb indwelling catheter has definite size limitations. On the one
hand, it has to be large enough to retain the distal end of the
catheter in the bladder when the bulb is inflated after insertion.
On the other hand, it should not be so large as to interfere with
the efficiency of the catheter as a drainage device or to cause
undue irritation of the bladder.
These size limitations are important when it is considered that the
elastic reservoirs in use today have fairly high fluid losses
through their walls and the difference in volume between maximum
and minimum desirable inflation of the retention bulb is not very
great.
Attempts have been made in the past to provide self-inflating
catheters with small reservoirs by coating the distended reservoir
with various gas and vapor retentive coatings. Unfortunately,
however, such coatings are comparatively inelastic (and some become
more so on aging) when compared with the elastic rubber reservoir
and, therefore, must be kept at a thickness considerably less than
optimum in order to avoid restricting reservoir deflation.
Furthermore, such coatings may present a very unattractive
appearance when the reservoir is deflated and their thinness
restricts the loss of fluid to the bare minimum necessary for
practical usage. What has been unattainable until this invention
has been a self-inflatable catheter whose shelf life has been
substantially increased.
It is the primary object of this invention to provide a cover for
the elastic reservoir of a self-inflating catheter which does not
inhibit deflation of the reservoir and which significantly reduces
fluid loss from the reservoir.
Other objects of the invention will be apparent from the drawings
and from the specification.
It has been found that a reservoir covering jacket whose walls are
of sufficient thickness to significantly reduce fluid loss is
effective in this respect provided a fluid-retaining seal is
maintained between the ends of the reservoir and the jacket.
Referring to the figures:
FIG. 1 illustrates a self-inflating catheter with the jacket of the
invention in place over the inflated reservoir thereof.
FIG. 2 illustrates in detail the jacketed reservoir of FIG. 1 prior
to inflation of the latter.
FIG. 3 is an illustration of the jacketed reservoir of FIG. 2 with
the reservoir partially inflated.
FIG. 4 is an illustration of the jacketed reservoir of FIG. 2 with
the reservoir fully inflated.
FIG. 5 illustrates the comparative values as fluid retentive
jackets of prolate spheroidal, true spherical and oblate spheroidal
jackets.
It has been found that when a tubular elastic reservoir is
inflated, it tends to assume a prolate spheroidal form in the
inflated portion. It would appear at first glance that a jacket
closely following the contour of the inflated reservoir would be
the most desirable form for a jacket. But as can be seen from the
schematic illustrations in FIG. 5 when partial fluid loss occurs,
the prolate jacket 30 begins to lose its fluid-retaining seal
first, the true spherical jacket 31 loses its fluid-retaining seal
next while the oblate jacket 32 is just at the point of losing its
fluid retaining seals. Thus, while all of the spheroidal shapes are
somewhat effective, the oblate jacket would prevent excessive loss
of fluid for a longer period than either of the other shapes.
However, while a spheroidal shape is the preferred shape, the end
seals and the distance between them are more important than the
jacket shape. For instance, one could utilize a cuboid shape so
long as the fluid-retaining seal areas are present at both ends and
the distance between them is less than the reservoir length when
partially inflated. The jacket obviously should not be
substantially greater in volume than the volume of the inflated
reservoir.
Referring once more to the drawings:
In FIG. 1, the self-inflating catheter 10 consists of a tubular
main drainage arm 11 with a connector end 12 and a discharge end 13
connected by a drainage channel 22. An inflating side arm 14
normally has its inflating channel 21 closed by a clamp 15 and its
proximal end closed by the plug 16. The inflating channel 21 and
the drainage channel 22 are contained within the main arm from the
point where the side arm 14 meets the main arm until channel 21
terminates in orifice 20 within the inflatable sleeve 19. On the
side arm 14, between the plugged proximal end and the point where
the side arm joins the main arm, an inflated reservoir 17 is
covered by and sealed against fluid loss by the spheroidal jacket
18 which compresses the reservoir longitudinally from its normally
prolate spheroidal shape to a more nearly spheroidal shape or even
to an oblate spheroidal shape. The compressed reservoir presses
against the jacket at each end to form pressure seals which
prevent, or at least very much restrict, fluid loss from the jacket
interior at the seals. In practice, the jacket is slipped over the
proximal side arm end in place over the reservoir and the latter is
inflated by a syringe or other fluid discharge means. The end seals
are so effective that to obtain maximum inflation of the reservoir,
it is desirable to vent the jacket as with the vent 23.
Substantially self-closing vents may be made in jackets of flexible
material by piercing them from the outside inwardly. This causes a
hole with rather jagged edges to be produced and as the reservoir
fills, the hole edges interfit to provide a substantial closure. It
is to be understood, however, that the jacket is effective whether
a vent is or is not provided, or whether the vent hole is
closed.
In FIG. 2, the reservoir 17 on side arm 14 is uninflated and seals
are not yet formed with the jacket 18.
In FIG. 3, the reservoir 17 has been inflated sufficiently so that
the reservoir ends are beginning to form seals against the jacket
interior. As soon as the seal is effective, the vent 23 relieves
the internal pressure between the reservoir and the jacket.
In FIG. 4, the reservoir 17 is fully inflated and the end seals
which progressively increase in width as the reservoir is inflated
meet near the equatorial circle of the jacket. The hole 23, if not
substantially closed is sealed around its edges by the inflated
reservoir.
Vents made in jackets with a hot needle and whose bores take an
hourglass configuration which measures at its widest point
approximately 0.012 inches in diameter cause fluid losses only
slightly greater than unvented jackets. With fully inflated 11 1/2
cc. reservoirs at 70.degree. F. maintained for 3 years, for
instance, such a vent causes the jacket to lose only one-half cc.
more fluid than an unvented jacket.
Preferably, the jackets of this invention are blow molded in one
piece of thermoplastic materials including glass. But they could be
made of metal. Plastic materials can be injection molded in two
pieces which can be joined by any of several methods including
solvent sealing, ultrasonic welding, heat sealing, cementing, etc.
For the most part, the wall thickness should be upwards of 5 mils
for most plastic jackets, somewhat less for glass jackets and at
least 1 mil for metal jackets. The thickness obviously depends upon
the strength and fluid transmission rate of the materials used.
Suitable thermoplastic materials include polyethylene,
polypropylene, polycarbonate, phenoxy resins and styrene blends
such as styrene-acrylonitrile resins. The latter three materials
like glass are very attractive because of their transparency.
Obviously, materials with low fluid transmission rates are to be
preferred since they may be made proportionately thinner.
While jackets with volumes in the range of 8 to 12 cc. are
preferred, the size is optional and animal catheters and special
hemostatic or pediatric catheters with larger or smaller retaining
bulbs may require proportionately larger or smaller reservoirs and
corresponding jackets.
It has been postulated [Journal of Polymer Science 18:201 (1955)
Berry and Watson] that stress relaxation of sulfur vulcanizates is
essentially the result of first order degradation of more than one
type of cross-link. Our own tests with vulcanized latex tends to
corroborate these postulations. But regardless of the explanation
of the deterioration of the rubber latex, the pressure within
inflated rubber latex reservoirs does deteriorate with time. If the
known deterioration in pressure continues for a sufficient period
of time, it eventually becomes insufficient to inflate the
retention bulb. With an unprotected aged reservoir, therefore, it
may be necessary to squeeze the reservoir to inflate the retention
bulb. I have discovered, however, that when the reservoir is
inflated but not permitted to assume its natural inflated contours,
the distorted inflated reservoir exerts a higher pressure upon the
same fluid contents than it does when it has its natural inflated
contours. Not only is this initially true but it continues to be
true as the pressures in the distorted and naturally contoured
reservoirs deteriorate with time. The jackets of this invention,
therefore, so long as they are effective in distorting the
reservoir, not only retain the fluid with minimal loss but also
retain the fluid at higher pressure than otherwise. This insures
that there will be sufficient liquid at higher pressure for a
longer period of time.
For example, when observed within the range of temperatures from
0.degree. F. to 120.degree. F., a coated catheter reservoir (1/4
mil polyvinylidene chloride coating) loses water approximately 60
percent as fast as an uncoated catheter. A catheter of the
invention (substantially spherical except at ends) loses water
approximately 10 percent as fast as an uncoated catheter so long as
the reservoir is effectively distorted.
Likewise, in the same observed temperature range, the jacketed
reservoir of the invention, when inflated with the same amount of
water as a similar but unjacketed reservoir, initially exerts a
greater pressure on the contents which can be regulated by the
relative size of the jacket but reasonably is in the range of 2 to
10 pounds per square inch greater. Until the jacket becomes
ineffective due to loss of the end seals, the difference in
pressure, while reduced, continues to be significant.
The jacketed reservoirs of this invention need not be integral with
catheters. In some embodiments the reservoir assembly is detachable
after inflation of the inflatable retention means. In other
embodiments the reservoir assembly is attached only during
inflation of the inflatable retention means. Connection may be
accomplished by insertion of a hollow needle or by well known
valvular means.
* * * * *