U.S. patent number 3,896,816 [Application Number 05/360,363] was granted by the patent office on 1975-07-29 for disposable catheter.
Invention is credited to Martin Mattler.
United States Patent |
3,896,816 |
Mattler |
July 29, 1975 |
Disposable catheter
Abstract
A catheter formed of an elongated, hollow tube having a sealed,
separate air passageway formed integrally of the tube and extending
from a point near the forward end of the tube to an integral air
inlet nozzle located near the rear end of the tube and extending
outwardly therefrom. An inflatable barrel shaped cuff is mounted
upon and encircles the tube near its forward end, there being an
opening in the tube wall communicating the interior of the cuff
with the air passageway for inflating and deflating the cuff. A cup
shaped seal is also mounted upon the tube and is frictionally
secured thereto by integral springy flanges which permit forwardly
sliding the seal upon the tube but which resists rearward sliding
of the seal.
Inventors: |
Mattler; Martin (Franklin,
MI) |
Family
ID: |
26837495 |
Appl.
No.: |
05/360,363 |
Filed: |
May 14, 1973 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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139725 |
May 3, 1971 |
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Current U.S.
Class: |
604/103.03;
604/918 |
Current CPC
Class: |
A61M
25/00 (20130101); A61M 25/1009 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 25/10 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348,349R,349B,35R,351,239-241,245,246,251,248,325,344 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Weiner; Irving M.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATIONS
This application is a continuation-in-part application of copending
U.S. Pat. application Ser. No. 139,725, filed May 3, 1971, for
"Disposable Catheter," now abandoned.
Claims
Having fully described an operative embodiment of this invention I
now claim:
1. A catheter comprising:
an elongated hollow tube having a forward end and a rearward end,
the forward end being provided with a plurality of apertures to
facilitate fluid delivery to a body cavity,
a first opening in the tube wall proximate the forward end
thereof,
a sealing cuff mounted upon the tube over the area including the
first opening, the sealing cuff comprising a thin walled, air
impervious, resilient rubber-like material,
the tube extending through the cuff and the cuff end portion being
sealed to the tube such that the cuff may be inflated to an
enlarged ring-shape co-axial with the tube for sealing a body
cavity within which the tube is inserted;
a second opening in the tube wall near the rearward end
thereof;
means disposed within the tube for interconnecting the first and
second openings,
a rearwardly and outwardly curved shield mounted below the cuff for
sealing the body cavity, the shield including a central opening and
having a rearwardly directed hub portion through which the tube is
fitted,
a plurality of fingers integrally formed with the hub and extending
rearwardly therefrom, the fingers permitting forward sliding of the
shield while resisting rearward movement of the shield,
means for mounting the shield on the tube, the mounting means
including an elongated slot provided through the shield and a
coupling means for closing the slot,
positive stop positioning means formed on the exterior of the tube,
the means comprising at least one forwardly directed bead tapering
outwardly from the tube, and wherein
the openings and the means for interconnecting the openings
cooperate to define an air inlet for flowing pressurized air into
and for discharging air from the cuff to inflate and deflate,
respectively, the cuff after the tube is inserted into the body
cavity.
Description
BACKGROUND OF THE INVENTION
Catheters generally comprise an elongated tube for insertion into a
body cavity and an inflatable cuff or sealing device for sealing
against the body cavity opening around the tube to prevent fluid
leakage around the tube. An example of such a catheter is found in
my prior U.S. Pat. No. 3,417,753 granted Dec. 24, 1968.
In the past, catheters, along with other medical appliances, were
reused and sterilized after each use. However, due to the
difficulties of sterilization and the expenses of labor in
connection with any cleaning and resterilizing of medical
appliances, efforts have been made to make many medical appliances
disposable, that is, single use. This is particularly true with
regard to catheters primarily designed for insertion into anal
cavities. It has been medically proven that it is impossible to
provide that degree of sterilization of anal catheters necessary to
prevent the transference of pathogens from one patient or user to
another. Thus, anal catheters must be disposable. This means, that
the construction must be so inexpensive that it is more economical
to throw away the appliance rather than to clean and reuse it.
However, the appliance must be made well so that it functions
properly on its first and only use.
The foregoing patent illustrates an example of a catheter made for
single use. However, it is desirable to make improvements upon such
catheter particularly to reduce its overall diameter and to
eliminate tubes or other items which are separate from the basic
catheter tube, in order to facilitate ease of entry into and
withdrawal out of the body cavities. Thus, the invention herein
relates to a disposable or single use catheter which is an
improvement over prior catheters.
SUMMARY OF THE INVENTION
The invention herein relates to a disposable or single use catheter
formed of a tube having an integral, internal air passageway which
utilizes only a small portion of the cross-section of the tube. The
tube carries a barrel shaped inflatable cuff of normally small
diameter, but which may be easily inflated into an adequate
diameter for sealing against the wall of a body cavity, around the
tube. The tube also carries a separate slidable plastic shield for
sealing against the body area defining the opening within which the
catheter tube is inserted. The shield includes means for
facilitating placement thereof on the exterior of the tube or
shank.
The tube also has means for positive stop positioning formed on the
exterior thereof. The catheter also includes means for facilitating
fluid flow into a body cavity through the head of the tube.
The invention herein contemplates forming the catheter tube with
its barrel-shaped cuff of simple and inexpensive construction,
while at the same time having the structural strength and
configuration to adequately perform its function.
These and other objects and advantages of this invention will
become apparent upon reading the following description of which the
attached drawings form a part. In the drawing like reference
characters refer to like parts throughout the several views in
which:
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an elevational view of a catheter assembly;
FIG. 2 is an enlarged, fragmentary cross-sectional view of a
catheter assembly;
FIG. 3 is a cross-sectional view of the catheter tube, taken in the
direction of arrows 3--3 of FIG. 2;
FIG. 4 is a perspective view of the inflatable cuff;
FIG. 5 is a cross-sectional view taken in the direction of arrows
5--5 of FIG. 4 of the cuff;
FIG. 6 is a fragmentary view showing the connection or sealing
between the cuff and the tube;
FIG. 7 is a perspective view of the cup-shaped, external
shield;
FIG. 8 is an enlarged, fragmentary view of the means for mounting
the shield upon the catheter tube;
FIG. 9 is a side elevational view of an alternate embodiment of a
catheter tube, and
FIG. 10 is a perspective view of an alternate embodiment of the
external shield.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In copending U.S. Patent application Ser. No. 139,725, the
disclosure of which is hereby incorporated by reference, there is
described a first embodiment of the present invention, and is
detailed in FIGS. 1-8, hereof.
FIGS. 1 and 2 illustrate the catheter assembly 10 of the first
embodiment and which includes an elongated, thin wall, hollow tube
11, formed of a suitable plastic material. The central opening of
the tube forms a fluid passageway 12 which extends from the forward
rounded or bulbous end or head 13 through which it opens at 14, to
the rear or opposite end 15 of the tube 11. The rear end of the
tube is formed with a suitable hose grip configuration 16 over
which a conventional rubber-like hose (not shown) may be slipped
and frictionally engaged and retained in place.
As shown in FIGS. 2 and 3 a transversely arranged, longitudinally
extending internal flat strip 17 is integrally formed within the
tube 11. The strip 17 is closely adjacent to a segment of the tube
wall, as shown, with the long edges of the strip integral with the
wall. The forward end 18 of the strip 17 is integral with the tube
wall near the forward end of the tube. Likewise, the rear end 19 of
the strip 17 is integral with the tube wall near the rear end 15 of
the tube. Thus, the strip, in conjunction with a segment of the
wall of the tube, defines a closed air passageway 20 which, as
illustrated in FIG. 3, occupies a relatively minor portion of the
cross-section of the interior of the tube, so that the major
portion of the interior cross-section is unobstructed for fluid
passage through the passageway 12.
The air passsageway 20 opens at 21 into an integral air nozzle 22
which extends angularly outwardly of the tube near its rear end 15.
A hose grip configuration 23 (FIG. 1) is formed on the end of the
air nozzle 22 so that a rubber-like tube or other suitable hosing
(not shown) may be slipped over and frictionally gripped upon the
nozzle 22. The hosing is attached at its other end to a source of
compressed air (not shown) which delivers or supplies compressed
air into the air passageway 20. As is described hereinafter, the
compressed air is employed to inflate a suitable cuff which aids
fluid retention in a body cavity.
Referring to FIG. 2, air opening 24 is formed in the tube wall at
the forward end of the air passageway 20. The area around the air
opening 24 is covered by an inflatable cuff 25. The cuff 25 is,
preferably, formed of an air impervious, inflatable, resilient and
flexible material, such as latex or a rubber-like material. In the
embodiment shown in FIGS. 1-8, the cuff 25 has a central
barrel-shaped portion 26 and integral, opposed short cylinder end
portions 27. Annular grooves 28 (FIG. 6) are formed in the tube
wall beneath the cuff cylinder portions 27, O-rings or O-ring seals
29 are provided to surround the cylinder portions 27 and to be
positioned over the grooves 28. The seals 29 frictionally anchor
and seal the cylinder portions to the tube wall 11.
The barrel-shaped portion 26 of the cuff 25 is provided with a
plurality of inwardly directed pleats or flutes 30 (see FIG. 5).
These pleats 30 extend the full length of the barrel-shaped portion
26. They invert when the cuff is inflated to permit the relatively
small diameter uninflated cuff 25 to expand into a substantial
inflated diameter.
As best depicted in FIGS. 2 and 7, for sealing against the body
portion surrounding the entry to a body cavity, a shield 35 is
mounted upon the tube 11. The shield 35 is mounted below the cuff
25 and engages the body portion surrounding the cavity. The shield
35 is rearwardly and outwardly curved, relative to the tube 11, and
forms a cup shape portion 36. The shield 35 has central opening 37
surrounded by a rearwardly directed hub portion 38 through which
the tube 11 is closely fitted. Springy fingers or flanges 39
integral with the hub 38 extend rearwardly therefrom. The flanges
39 frictionally engage and grip against the tube 11. The shield is
formed of a springy, relatively flexible plastic material which,
while being stiff enough to maintain its normal shape, may be
sufficiently bent and flexed to conform more closely to the body
portion against which it engages.
The springy fingers or flanges 39 are tapered inwardly relative to
the axis of the tube to frictionally grip against the tube wall, as
illustrated in FIG. 8. Thus, the shield may be easily slid towards
the forward end or head of the tube but resists sliding backwards
towards the rear end of the tube due to the increase in frictional
engagement between the fingers or flanges and the tube wall.
Referring now to FIGS. 9 and 10, there is depicted therein an
alternate embodiment of the present invention. In this embodiment
there is provided an elongated tube or shank 111 having a central
fluid passageway 112. The passageway 112 extends from the forward
end or head 113 of the tube 111 to the rearward end 114 of the
tube. The internal configuration of the tube is the same as
hereinabove described including the air passageway in communication
with a cuff 115 through an air nozzle 116. A hose 117 is connected
to the nozzle 116 and is gripped thereonto by suitable gripping
means 118. The gripping means 118 is analogous to the grip
configurations 23 and 16 of the hereinbefore described
embodiment.
The hose 117 is connected at its other end to a source of
compressed air or the like (not shown) for inflating the cuff 115
through the air passageway.
In order to facilitate fluid flow through the fluid passageway and
in accordance with the present embodiment a plurality of fluid
delivery apertures 119 are circumferentially disposed about the
tube 111 proximate the head 113. A central fluid delivery apertures
120 is also provided at the terminus of the fluid passageway 112.
By providing a plurality of fluid delivery apertures 119, 120, the
fluid flow pressure of the fluid exiting from the tube is greatly
decreased. Concomitantly a greater volume of fluid can be
introduced into a body cavity with less discomfort to the body.
As shown in FIG. 9, the tube 111 has formed on the exterior thereof
positive stop positioning means 121. The positive stop positioning
means generally comprise at least one forwardly directed bead 122.
The bead 122 tapers outwardly from the tube 111, as at 123, and
thereby defines a ledge 124 which extends circumferentially around
the tube 111.
The ledge 124, acts as a barrier to limit or retard any motion of
the shield 125 toward the rear 114 of the tube 111 in a manner
described subsequently. The bead 122 may be integrally formed, such
as by molding or the like, or otherwise affixed to the exterior of
the tube 111 in the medial portion thereof. A plurality of beads
122 are provided to accommodate varying placements of the shield
125.
In the present embodiment of the invention and as shown in FIG. 10,
the shield 125 also includes means 126 for mounting the shield on
the tube 111. The means 126 generally comprises an elongated slot
or cut-out portion 127. The slot 127 is provided along the
cup-shaped portion 128 as well as through the hub portion 129.
Because of the materials used to manufacture the shield, the
mounting thereof is facilitated by the slot 127. The slot affords
flexure of the shield to enable its mounting either between two
beads, or between a bead and the cuff 115. The resiliency of the
shield maintains its frictional mounting on the tube. In order to
insure that the shield remains locked around the tube means 136 are
provided. The means 136 generally comprises a male-female coupling
137, 138 formed on the interior surface of the cup-shaped portion
of the shield 127 proximate the area of the slot 127. Preferably,
the coupling 137, 138 is a detente arrangement which functions in a
known manner. Because of the flexibility of the shield engagement
and interlocking of the coupling 137, 138 is possible. Moreover, by
interlocking the shield any possibility of the shield flexing and
sliding off the tube is prevented. In all other respects, the
shield 125 is the same as the shield 35 hereinbefore described.
It is seen that, in accordance with this embodiment of the
invention, if the shield 125 moves toward the rear 114 of the tube
111, the flanges 130 of the shield 125 will abut and engage a ledge
124 to prevent any movement of the shield therepast, thus providing
positive stop positioning of the shield.
Because the catheter hereof is primarily intended for insertion
into an anal cavity, the shield provides two important functions.
First, the shield functions as a safety means to prevent and
inhibit premature fluid leakage out of the anal cavity. Secondly,
the shield functions as a safety stop if the cuff is improperly
positioned or if the user or patient attempts to expel the cuff
with internal pressure. Thus, the shield is critical to the overall
efficacy and efficiency of the present catheter.
Referring again to FIG. 9, the cuff 115 used herein can comprise
the fluted cuff 25 heretofore described or any other suitably
configured cuff. In the embodiment of FIG. 9, the cuff 115 includes
a central toroidal portion 131 and integrally formed opposed
elongate portions 132 and 133, respectively. The elongate portion
133 can be inverted within the toroidal portion 131 and clamped in
the annular groove 134 through an O-ring seal, as hereinbefore
described.
Similarly, the elongate portion 132 can be clamped in the annular
groove 135 through an O-ring seal (now shown).
It is to be understood though, that the heretofore described fluted
cuff can be used with equal efficacy in this embodiment and vice
versa.
It will be appreciated by those skilled in the art, that with the
present invention there is provided means for facilitating fluid
flow, means for mounting the shield, and means for positive stop
positioning the shield, all of which facilitate the use and
deployment of a disposable catheter.
OPERATION
In operation, a rubber hose is assembled to the rear end
configuration of the tube for the passage of fluids. A separate
rubber hose or tube is connected to the air nozzle, frictionally
engaging the grip portion 23 of the nozzle. Air is pumped through
the air passageway by means of a suitable hand pump or the like, to
inflate the barrel-shaped or toroidal portion of the cuff. This is
done after the catheter tube is inserted into the body cavity the
required distance. Thereafter, the shield 35 is slid towards,
against and into snug contact with the body portion surrounding the
entrance to the body cavity where it functions to limit the leakage
of fluid around the outside of the tube. The shield resists sliding
backwards and remains in place after contacting the body portion
and is aided and abetted by the positive stop positioning means.
For removal, air is permitted to escape out of the nozzle to
deflate the cuff, and the tube is withdrawn from the body
cavity.
With the foregoing construction, the cuff inflates uniformly and
symmetrically about its center axis, with its wall thickness
remaining uniform. This is an improvement over the prior catheters
which have a tendency to inflate non-symmetrically and with
corresponding bulges and non-uniform wall thicknesses.
* * * * *