U.S. patent number 3,736,939 [Application Number 05/216,230] was granted by the patent office on 1973-06-05 for balloon catheter with soluble tip.
Invention is credited to Glenn N. Taylor.
United States Patent |
3,736,939 |
Taylor |
June 5, 1973 |
BALLOON CATHETER WITH SOLUBLE TIP
Abstract
A flexible retention catheter of the balloon inflation type is
provided with an auxiliary drainage opening in the wall of the
catheter, situated below the inflation balloon, and with an
imperforate tip composed of a material which is soluble in body
fluids. During insertion, drainage is initiated only through the
auxiliary opening. Upon dissolution of the tip, the whole diameter
of the lumen of the catheter becomes available for drainage.
Inventors: |
Taylor; Glenn N. (Barrington,
IL) |
Family
ID: |
22806275 |
Appl.
No.: |
05/216,230 |
Filed: |
January 7, 1972 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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1471 |
Jan 8, 1970 |
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692853 |
Dec 22, 1970 |
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Current U.S.
Class: |
604/265; 604/275;
604/915; 604/96.01 |
Current CPC
Class: |
A61M
25/10 (20130101); A61M 25/0069 (20130101) |
Current International
Class: |
A61M
25/10 (20060101); A61M 25/00 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348,349R,349B,349BV,35R,351,343,344,239-246 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Brit. Med. Journ. 25 Feb. 1967 pg. 485.
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Primary Examiner: Truluck; Dalton L.
Parent Case Text
This is a continuation of application Ser. No. 1,471, filed Jan. 8,
1970, which is a continuation-in-part of U. S. Ser. No. 692,853,
filed Dec. 22, 1970, both now abandoned.
Claims
Having thus described my invention, I claim:
1. A flexible retention catheter of the balloon inflation type
which comprises
a flexible tubular body portion with an inflatable balloon sealed
to said body near its distal end, said body portion having an open
end beyond said balloon,
and an imperforate distal tip portion terminating short of said
balloon and composed wholly of a substance which is soluble in body
fluids covering said open end,
said tubular body portion being provided with an unobstructed
auxiliary drainage opening in the main wall of said body
portion,
said auxiliary drainage opening being directly connected to the
drainage lumen of said catheter and being located near but below
the point of attachment of the inflatable balloon to said body
portion,
whereby the open end of the tubular body portion is covered during
insertion of the catheter, the unobstructed auxiliary drainage
opening will permit drainage of liquid as a signal to the operator
of the catheter that the balloon and distal end are properly
located before the balloon is inflated, and after the balloon is
inflated to secure the catheter in proper position, the imperforate
tip portion is dissolved to permit normal drainage.
Description
This invention relates to surgical retention catheters, and more
particularly to catheters provided with an imperforate, transient,
water-soluble tip.
Conventional catheters of the balloon-inflated retention type are
generally provided at one end with a rounded tip or head containing
one or more elongated openings to allow for the drainage of body
fluids through the catheter. These drainage openings in the tip of
the catheter are limited in size, since the larger they are, the
more they tend to decrease the rigidity and resistance to
distortion of the tip. Ideally, the insertion tip of a catheter
should be as resistant to distortion as the body portion thereof,
to resist doubling over upon insertion, with consequent discomfort
and pain to the patient.
As a result of this physical limitation on the size of the openings
in the catheter tip, the drainage of viscous fluids is impeded.
Furthermore, sediment or fragments of tissue may accumulate in and
around the eyelets or openings, with a slowing down or even
complete stoppage of the drainage function.
Ideally, once the catheter is in place, it would be desirable to
utilize the maximum drainage capacity of the catheter by having the
end of the catheter open and untipped. Open-end catheters have been
proposed wherein the tipless open end of the catheter tube is
provided with inserted reinforcing strips of latex-impregnated
fabric, as in U. S. Pat. No. 2,677,375. However, such catheters do
not have a smoothly rounded tip, so that an unprotected and
uncovered edge of the tube end comes in contact with the passage
through which the catheter is being threaded, with the danger of
injury to the patent.
It has also been proposed to provide irrigation devices with tips
which become soluble in aqueous fluids. However, all of such
devices known to me have soluble tips which are perforate, in that
they contain one or more drainage openings in the tip itself. Such
devices are not well-suited to function as retention catheters of
the balloon inflation type, since as soon as the perforate tip
enters the bladder, drainage will begin. The nurse will then
inflate the retention balloon, which may or may not be situated in
the desired position inside the bladder and resting against the
bladder wall. If the balloon is still in the upper portion of the
urethral canal, its inflation is accompanied by extreme discomfort
to the patient.
It is an object of this invention to provide a retention catheter
of the balloon inflation type which can be inserted with maximum
ease and lack of discomfort and which, once in place, offers
maximum drainage capacity, and which minimizes the danger of
premature inflation.
It is a further object of this invention to provide a retention
catheter with a rounded, imperforate atraumatic tip which is
capable of dissolving in body fluids.
The invention will be better understood with reference to the
following description and drawing, in which:
FIG. 1 is a cross-sectional view of the catheter of this
invention.
Referring to FIG. 1, there is shown an inflation catheter with a
flexible body portion comprising sidewalls 12--12, of conventional
construction, surrounding the drainage lumen 11. The insertion end
of the catheter is provided with a tightly fitting rounded
imperforate tip 10 formed from a substance which is firm and
resilient when dry, but is capable of softening and dissolving in
body fluids such as urine.
The catheter of this invention is of the inflation balloon type,
wherein the drainage lumen 11 is provided with an inflation wall
channel 22, said channel having the conventional angularly disposed
inflation connection, not shown, by means of which fluid is
transmitted through the channel and the communicating opening 20 to
inflate the balloon 18, situated near the distal end of the body of
the catheter and sealed thereto, said balloon and inflation lumen
being well-known and conventional.
The catheter is also provided with an auxiliary drainage opening 24
in the wall 12, opening directly into the main drainage lumen 11.
Such an opening assists in the drainage of small subnatant pockets
of body fluids which may accumulate when the inflation of the
balloon walls 18 causes the open tip of an indwelling catheter to
project an appreciable distance beyond, for instance, the wall of
the human bladder. More importantly, as the catheter is being
inserted, the actual soluble tip of the catheter is closed, and
drainage can begin only through this auxiliary opening 24. Thus,
during the insertion process, the initiation of drainage is a sure
sign to the nurse that the balloon portion of the catheter is
inside the bladder, and that inflation can be safely carried out
without discomfort to the patient.
The imperforate water-soluble catheter tip 10 should fit snugly and
firmly over the open end of the catheter tube. It is, however,
generally of thinner wall construction than the walls 12 of the
catheter, a wall thickness of 2-5 mils facilitating satisfactorily
rapid disintegration when the tip is immersed in, for example,
urine. It may be fashioned from any suitable substance which has
the property of forming a solid film capable of softening and
dissolving in aqueous fluids, such as gelatin, methyl cellulose,
polyvinyl alchol, polyethylene oxide, polyvinyl pyrrolidone, and
the like. These may be used alone, or in combination with
water-soluble non-toxic plasticizers such as various glycols, to
obtain the desired combination of flexibility and disintegration
time. The substance chosen preferably will disintegrate and
dissolve substantially completely when immersed in an aqueous fluid
of pH 5 to 8 for a period of not more than 5 minutes.
The use of a catheter with an imperforate tip soluble in body
fluids is especially advantageous when occasional irrigation is to
be carried out. In such procedures, substantial amounts of cellular
debris and disconnected fragmented tissue are frequently dislodged
which do not pass freely through the eyes of a conventional cather
tip, but tend to collect in and around the eyes to impede or
occlude the desired drainage function.
* * * * *