U.S. patent number 3,648,704 [Application Number 05/055,769] was granted by the patent office on 1972-03-14 for disposable catheter apparatus.
Invention is credited to Frederick E. Jackson.
United States Patent |
3,648,704 |
Jackson |
March 14, 1972 |
DISPOSABLE CATHETER APPARATUS
Abstract
A urethral catheter tube formed of a flexible low-friction
plastic is carried in a transparent plastic casing one end of which
is flattened and severably joined to a plastic cap member. The
other end of the casing is closed to form a reservoir. The cap
member is a closed vessel containing a lubricant. When the cap is
separated from the casing it can be opened to permit application of
the lubricant and the casing also opened to permit insertion and
implantation of the catheter. Both the lubricant and the catheter
tube can be maintained in a sterilized condition and the catheter
remains sterile during implantation since it can be worked out of
the casing by aseptically contacting it through the casing walls,
the net result being that the catheter need not be contacted by
human hands.
Inventors: |
Jackson; Frederick E. (Camp
Pendleton, CA) |
Family
ID: |
22000033 |
Appl.
No.: |
05/055,769 |
Filed: |
July 17, 1970 |
Current U.S.
Class: |
604/172; 206/364;
206/459.5; 206/568; 383/209 |
Current CPC
Class: |
A61M
25/0111 (20130101); A61M 25/002 (20130101); A61M
2025/0062 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/01 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348,349R,35R,260,261,239 ;206/63.2R |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. Disposable catheter apparatus comprising:
a flexible transparent elongate open-ended tubular casing member
having one of its ends closed for providing a baglike receptible
portion,
an elongate flexible catheter tube longitudinally disposed within
said casing,
a cuplike open-ended capping member having its open end portion
sized to match the open end portion of said casing member,
fluid catheterization material carried by said capping member,
the open ends of the casing and capping members being pressed
together to provide a flattened sheetlike multi-ply section common
to both members and said section having its plies severably united
for sealably closing both of said members,
whereby the contents of said members can be maintained in a
sterilized condition and the catheterization can be conducted by
separating said members and reopening said open ends,
the reopening permitting said sterilized fluid material to be
applied for catheterization and said sterile catheter tube to be
worked out of said casing for implantation by asceptically
manipulating the catheter tube through contact with the casing,
said envelope then providing a baglike reservoir for receiving
fluids delivered through the implanted catheter tube.
2. The apparatus of claim 1 further including means for positively
retaining a portion of the tube within the casing whereby the
retained portion provides a conduit communicating with said baglike
receptacle.
3. The apparatus of claim 2 wherein said retaining means includes a
ferrule fixedly disposed interiorally of said casing and a flanged
lock ring carried by said catheter tube, said lock ring mating with
said ferrule whereby said flanged portion restrains movement of the
tube outwardly of the casing.
4. The apparatus of claim 2 wherein said catheter tube is formed of
a smooth low-friction plastic.
5. The apparatus of claim 4 wherein said fluid material is a
lubricant adapted to be applied to the catheter tube and the
patient for facilitating catheterization.
6. The apparatus of claim 2 wherein said baglike receptacle portion
of the casing is expandable to increase its capacity.
7. The apparatus of claim 6 wherein said baglike receptacle is
formed with longitudinal pleats permitting said expansion.
8. The apparatus of claim 7 wherein said pleated portion bears
indices designating volumetric contents of the reservoir.
9. The apparatus of claim 1 wherein said casing and capping members
both are formed of a heat-sealable plastic material and said
sheetlike section common to both members is heat-sealed.
10. The apparatus of claim 1 wherein said common section includes a
weakened portion extending as a tear line transversely of the
section.
Description
The invention described herein may be manufactured and used by or
for the Government of the United States of America for governmental
purposes without the payment of any royalties thereon or
therefor.
BACKGROUND OF THE INVENTION
The present invention relates to disposable catheters and, in
particular, to sterile catheter apparatus which can be applied
manually without direct contact by human hands or other unsterile
objects.
Many hospital patients require urethral catheterization and one of
the serious problems in the treatment of these patients is to
prevent urinary infections. Infections, however, can be
substantially reduced by limiting the period of time in which the
catheter remains in place or, in other words, by employing an
intermittent rather than an inlying technique. Even so, the
intermittent technique presents real problems that have greatly
restricted its obviously beneficial use. The principal problem
arises because of the relative frequent need for catheterization
coupled with the requirement that each operation must be conducted
with sterile equipment and by trained personnel to assure aseptic
cleanliness. These requirements apparently have proven too
demanding particularly for hospitals or clinics which are
notoriously overcrowded and understaffed.
However, there have been several prior art arrangements which
utilize disposable catheters that can be handled aseptically. The
aseptic handling is achieved by enclosing the catheter tube in an
envelope in such a manner that the tube can be inserted by
retracting the envelope while pressing the tube in an outward
direction. Since the tube itself is not directly touched, it
remains sterile. Also, the disposability of the entire arrangement
avoids the need for resterilization.
Such prior art arrangements clearly are advantageous, although
unfortunately they have not been adapted and used to any
appreciable extent. Apparently the reason for their low use has
been that the specific arrangements have been rather impractical,
difficult to use and relatively expensive. Further, they do not
provide in one unitary package all of the necessary components and
materials such, for example, as a sterile lubricant to facilitate
insertion or a convenient receptacle for collection of the samples.
The need is to provide a catheter package that can be distributed
economically to patients with assurance of convenient,
noninfectious use as the occasion arises.
OBJECTS OF THE PRESENT INVENTION
It is, therefore, one of the objects of the present invention to
provide a low cost, disposable catheter apparatus including a
catheter tube capable of being aseptically handled, a lubricant and
a convenient receptacle for collection of samples through the
implanted catheter tube.
Another object is to provide a convenient and relatively
inexpensive packaging arrangement for such catheter apparatus, the
convenience permitting use by relatively untrained personnel.
A further more specific object is to provide a packaging
arrangement in which the lubricant and the catheter tube are
separately sealed in their own containers which, in turn, are
joined so that separation of the two containers permits both to be
opened for use.
Another specific object is to provide catheter apparatus in
accordance with the foregoing objects, the container of the
catheter tube also providing a receptacle for sample
collection.
These and other objects which will become more apparent are
achieved by providing apparatus including a flexible, transparent,
open-ended tubular casing that encloses an elongate flexible
catheter tube. One end of the casing is closed to provide a baglike
receptacle for sample collection through the tube after it has been
implanted. The other end of the casing is joined to a cuplike
capping member and, preferably, the joined ends of the casing and
the capping member both are constricted or pinched together for
sealably closing the interiors of each of the members. A lubricant
or other catheterizing material is contained in the cuplike member
and the sealing of this member, as well as the casing member,
permits the contents of both of these members to be maintained in a
sterilized condition. Separation of the two members permits both to
be opened and the contents exposed for use. The caplike member can
be squeezed to apply lubricant, while the casing member can be
manipulated to progressively work the catheter tube outwardly from
the casing to permit its insertion and implantation. The lack of
any direct contact by human hands of the tube itself maintains a
sterile, aseptic condition of the tube and, most suitably, the
extent to which the tube can be worked out of the casing is limited
so that a length of the tube remains in the casing to provide a
communication between the body cavity and the receptacle portion of
the casing.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention is illustrated in the accompanying drawings of
which:
FIG. 1 is a face view showing the transparent package or casing of
the catheter apparatus and certain of the components contained in
the package;
FIG. 2 is a longitudinal section taken along lines 2--2 of FIG.
1;
FIG. 3 is a section similar to FIG. 2 of the catheter tube portion
of the apparatus; and
FIG. 4 is a perspective illustrating the capping member and the
manner in which it is used.
DETAILED DESCRIPTION OF THE INVENTION
Referring to FIGS. 1 and 2, the catheter apparatus is shown
enclosed in a transparent, plastic envelope or package generally
indicated by numeral 1, the envelope being formed of an elongate
casing member 2 and a capping member 3. Ends 4 and 6 of the
envelope both are closed by any appropriate means, such as by
heat-sealing, so that, in effect, both casing member 2 and capping
member 3 are provided with closed ends permitting both of these
members to be used as containers in a manner which will be
described. The other ends 7 and 8 of the casing and capping members
are joined together in such a manner that each of the members forms
a separate container. More specifically, end portions 7 and 8 are
compressed and separably joined again by a heat-sealing process or
the like. To permit separability of the casing member and the
capping member, the joined portions of these two members may be
scored, perforated or otherwise weakened so that the two members
readily can be separated by tearing. Alternatively, a tear strip
can be employed although obviously the tear line must not sacrifice
sealability which, in turn, assures sterility. The rip or tear line
for the members is indicated by numeral 9 of FIG. 1.
Casing member 2 sealably encloses an elongate catheter tube 11 as
well as a lock ring 12 which, for reasons to be set forth, is
provided to restrain the extent to which catheter tube 11 can be
worked outwardly of its casing or, in other words, to assure that a
portion of the catheter tube remains within casing 2. A sleeve or
ferrule 13 mounted on the trailing end of catheter tube 11
cooperates with lock ring 12 to achieve the desired restraining
action. As shown, ferrule 13 is fixedly mounted on the end portion
of tube 11 and the ferrule is formed with a reduced diameter
portion adapted to fit within the internal diameter of ring 12, the
remainder of the ferrule being enlarged so as to provide a flange
14 which abuts ring 12 and restrains further outward movement of
the tube. Ring 12 also is fixedly mounted by being joined in an
appropriate manner to the plastic casing member.
Catheter tube 11 may be of any conventional type although
preferably it should be formed of a smooth-surfaced silastic
material which is of low friction material adapted to facilitate
use of the tube. Also to facilitate use, the tube should be
flexible although a certain degree of stiffness is needed to assure
insertion. In this regard, it no doubt is apparent that the present
apparatus primarily is intended as an urethral catheter although
the packaging arrangement could with certain modifications be
adapted for other catheterizing applications. As an urethral
catheter, the tube is hollow and open-ended, the leading end of the
tube being slightly enlarged and provided with particular opening
16 which permits flow from the bladder through the tube into the
casing.
Cap member 3 provides a separate container coupled to casing member
2 in the manner already described, this member being used to
provide a lubricating material facilitating the insertion of
catheter tube 11. More specifically, cap 3 is filled with a
lubricant 17 which, when the cap is separated from casing member 2
becomes available for use both on the tip of catheter tube 11 and
around the entrance to the urethral passage.
Other features of the invention best can be appreciated by
considering the manner in which the present catheter apparatus is
used. In fabricating the apparatus, the catheterizing components
such as tube 11 and lubricant 17 are enclosed in envelope 1 and the
envelope heat sealed to provide a tight closure which then can be
sterilized in any suitable manner to maintain these components in
an aseptic condition. The packaged apparatus then may be marketed,
stored and distributed as sterile packages and the notation
"STERILE" can, if desired, be marked on the exterior of the
package. Also, distribution of the packaged apparatus either can be
to hospital personnel trained to perform the catheterizations or
relatively untrained personnel, such as patients themselves, can
perform the task with very little preliminary instruction. When
catheterization is required, the user simply separates the cap
member from the casing member by ripping the package along line 9
and the separation causes ends 7 and 8 of these members either to
open or to be readily openable. The first step, as has been
indicated, is the application of sterile lubricant 17 and, as
desired, the lubricant can be applied both to end 16 of the tube
and to the urethral passage. Preferably, application of the sterile
lubricant to the end of the tube is accomplished as soon as the tip
end is exposed, although it may be desirable to apply a small
amount of the sterile lubricant to end 7 of casing member 2 prior
to initial exposure of tip 16. The manner in which lubricant 17 is
applied is illustrated in FIG. 4 where it will be seen that
application can be accomplished simply by squeezing cap member 3 to
extrude whatever amount of lubricant may be required. Obviously, it
is desirable that lubricant 17 be somewhat viscous so that a
squeezing action is required for the application.
In a manner intended to be illustrated by FIG. 3, catheter tube 11
can be progressively inserted into the urethral canal for
implantation in the bladder of a patient without directly
contacting the tube with human hands or other instruments which
might produce contamination and destroy its aseptic condition. More
specifically, the tip portion of tube 11 can be exposed by grasping
the tube through package 2 and moving the tube relative to the
package to cause tip 16 either to break through the closed end of
the package or, if this end is already open, to pass through the
opening. Tip 16 then is inserted in the urethral passage and the
tube progressively worked into implanted disposition by gently
continuing the forward thrust of the tube relative to casing member
2, the casing member being retracted in the manner shown in FIG. 3
as the progressive insertion is accomplished. The tube, of course,
is of sufficient length to extend fully into the bladder of the
patient and, when so implanted, the tube may be locked in position
by retracting the casing to contact its ring 12 with locking
ferrule 13. The apparatus then is in position to receive urine
samples which pass through the tube into the rearward portion of
the casing, this rearward portion preferably being provided with
longitudinal pleats 18 (FIG. 1) to provide a baglike reservoir to
receive the sample.
Another distinct advantage of the present apparatus is that it can
be manufactured relatively inexpensively and that its components
also can be made from inexpensive materials, these features provide
a total package which permits disposability after each use without
any particular economic sacrifice. In this regard, it has been
pointed out that the present catheter is intended for intermittent
catherizations as opposed to the more conventional inlying
Foley-type catheters which, as has been demonstrated in practice,
are far more prone to produce infection due entirely to the period
of time in which they remain implanted. The particular advantages
of the present apparatus are found in the ability to handle the
catheter tube aseptically so as to avoid the need for
sterilizations or resterilizations upon each use or reuse.
Disposability obviously avoids the prior need for resterilization.
In addition, the apparatus includes all of the elements necessary
for intermittent catheterization, these elements, in addition to
the catheter tube itself, being the ready availability of lubricant
17 as well as the availability of a baglike reservoir portion of
the casing as a sample collector. A further refinement of the
apparatus is to mark the pleated portion of the casing in graduated
cubic centimeter indices to provide a visual indication of the
volume of the sample. In total, a complete catheterizing package is
provided which can be conveniently and easily used in a safe and
reliable manner and which, after collection of a sample from its
receptacle portion, can be disposed of at minimum expense.
Obviously many modifications and variations of the present
invention are possible in the light of the above teachings. It is
therefore to be understood that within the scope of the appended
claims the invention may be practiced otherwise than as
specifically described.
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