U.S. patent number 3,633,586 [Application Number 05/033,374] was granted by the patent office on 1972-01-11 for sterile technique tube end closure and syringe adaptor.
Invention is credited to David S. Sheridan.
United States Patent |
3,633,586 |
Sheridan |
January 11, 1972 |
STERILE TECHNIQUE TUBE END CLOSURE AND SYRINGE ADAPTOR
Abstract
A tube end closure for medicosurgical tube devices having an
encircling removal cap that is captive to the closure body is
molded as an integral unit from plastic material. The closure is
constructed to make fluidtight union with tapered connectors of
Luer syringes. A syringe needle penetratable plug may be fixed
inside the closure sufficiently below the proximal end tip so
contact of the plug will occur only with a syringe needle when
fluids are injected or withdrawn via the closure.
Inventors: |
Sheridan; David S. (Argyle,
NY) |
Family
ID: |
21870063 |
Appl.
No.: |
05/033,374 |
Filed: |
April 30, 1970 |
Current U.S.
Class: |
128/207.15;
215/306; 604/96.01; 138/89; 285/901 |
Current CPC
Class: |
A61M
16/04 (20130101); A61M 39/20 (20130101); A61M
16/0434 (20130101); Y10S 285/901 (20130101) |
Current International
Class: |
A61M
39/00 (20060101); A61M 39/20 (20060101); A61m
025/00 () |
Field of
Search: |
;128/348-351,246,325,344,214.4 ;222/542,543 ;215/41,73,99 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
The embodiments of the invention in which an exclusive property or
right is claimed are defined as follows:
1. An endotracheal tube comprising an inflatable balloon cuff, a
secondary lumen and an inflation tube joined to the proximal end of
the secondary lumen through which the balloon cuff may be inflated
via the secondary lumen, a tube end closure fixed to the proximal
end of said inflation tube, said end closure comprising a distal
end portion, a proximal end portion, a central body portion, a
removal cap for said proximal end portion and fastener strip
through which said cap is tied to said central body portion, all of
said portions and strip being molded of plastic material as an
integral unit, said proximal end portion being of larger diameter
than said distal end portion, said central body portion being
tapered from said proximal end to said distal end, said removal cap
comprising a cylinder portion of inside diameter approximately
equal to the outside diameter of said proximal end portion, a
transverse top and a central plug depending concentrically inside
said cylinder portion from said top, said plug having an outside
diameter approximately equal to the inside diameter of said
proximal end, said plug being shorter in length than said cylinder
portion whereby the free end of said plug is recessed within said
cylinder portion, and a plug fixed within said tapered central body
portion of the end closure made of soft elastomeric material that
may be penetrated by a syringe needle and will reseal upon
withdrawal of the syringe needle.
Description
BACKGROUND OF THE INVENTION
This invention relates to end closures for medicosurgical tube
devices which serve not only to maintain sterile conditions in the
handling and use of the devices, but also as adapters for
operatively connecting a syringe to the medicosurgical tube device
as may be required for injection or withdrawal of fluids through
the device.
Devices in he form of tubes involving a distal end which is
inserted into a patient and a proximal end through which fluids may
be introduced or withdrawn in the treatment of a patient are made
in a variety of forms. Some of these are called catheters, e.g.,
suction catheters, Foley catheters, urethral catheters, thoracic
catheters, and the like. In other cases, the devices are referred
to as cannulae, e.g., nasal oxygen cannulae, intravenous cannulae,
etc. Additionally, the devices are referred to as tubes, e.g.,
stomach tubes, feeding tubes, rectal tubes, flush tubes,
endotracheal tubes, and the like. This invention is contemplated
for use with all such devices where an end closure for sterile
technique procedures is necessary or desirable. The term
"medicosurgical tube" is used throughout the following description
and claims as a general term to encompass all such devices whether
they be referred to as catheters, cannulae, or tubes.
It is essential when any medicosurgical tube device is first
inserted into a patient for required treatment or operation, that
the device be in completely sterile condition. With such devices
that are reused a number of times, sterilization may be
accomplished by autoclaving or by immersion in sterilizing
solution. Sometimes such procedure fails to completely sterilize
the medicosurgical tube device and cross infection occurs in the
use of a single device upon multiple patients. In order to avoid
this, as well as expense of onsite sterilization with rising labor
costs, the present trend is to use medicosurgical tube devices
which are designed and constructed for disposal after use upon a
single patient. Improvements of the present invention are
contemplated for use on both these general classes of devices, but
they are particularly advantageous with regard to medicosurgical
tube devices of the disposable type.
In many types of medical or surgical procedures, once a sterile
medicosurgical tube device has been inserted in a patient, the
proximal end will be attached to some auxiliary equipment so that
the device is sealed off from the ambient atmosphere and sterile
conditions throughout the interior of the tube device are
maintained until the treatment is terminated and the tube device
withdrawn from the patient. On the other hand, there are a number
of medicosurgical tube devices which by their nature and method of
use permit or require the proximal end to be intermittently exposed
to the ambient atmosphere, handled by a person attending the
patient, contacted by a syringe or other piece outside equipment or
the like. One example of this is feeding tubes for the nasogastric
feeding of both infant and adult patients. Such feeding tubes, once
inserted in the patient, remain in position for extended periods of
time although feeding liquids will be introduced through them into
the patient only at spaced intervals. During the periods of nonuse,
it is desirable that the proximal end of the feeding tube be closed
to prevent ingress of bacteria.
A somewhat different example of medicosurgical tubes which have a
proximal end element that in the course of treatment of a patient
receives intermittent use are endotracheal tubes. Normally these
involve a balloon cuff which is inflated by a secondary side tube
in order to retain the endotracheal tube within the patient during
administration of anesthesia or other fluids through the principal
lumen in treatment of the patient. With such devices, it becomes
necessary to introduce air or liquid through the secondary tube to
inflate the balloon cuff and this is normally accomplished using a
syringe to inject the fluid and apply the pressure required to
inflate the cuff. This may need to be repeated several times during
a given operation on a patient. Hence, it is desirable that such
tubes be provided with a syringe adapter which enables a syringe to
be quickly and easily applied and then withdrawn as required in the
particular circumstances.
Various schemes have been used in closing ends of medicosurgical
tubes during intermittent use as described or for adapting syringes
to the tube structures for whatever purpose this would be required.
For example, rubber plugs of stoppers have been used to close tube
proximal ends. Also, funnel-shaped caps have been used for this
purpose. Funnel-shaped ends have also been employed as connectors
or adapters for syringes to medicosurgical tube devices. However,
notwithstanding the various schemes or structures used heretofore,
there is need for improvement in end closures and syringe adapters
employed with medicosurgical tube devices, particularly from the
viewpoint of maintaining sterile conditions throughout use of the
device in treatment of patients and also in the simplicity and ease
with which the tube device may be adapted to a syringe or otherwise
manipulated as may be required by the treatment being applied to
the patient.
OBJECTS
A principal object of this invention is the provision of new forms
of sterile technique tube end closures and syringe adapters for
medicosurgical tube devices. Further objects include the provision
of:
1. New designs in the construction of catheters and other
medicosurgical tube devices that mitigate contamination in handling
and use of the devices.
2. Medicosurgical tube devices with end closures having a syringe
needle penetratable element through which fluids may be injected or
withdrawn, which element is protected against contamination during
handling and use of the device.
3. New end closures for medicosurgical tubes with captive removable
caps that are highly effective and easily manipulated in sterile
technique use of the device.
Other objects and further scope of applicability of the present
invention will become apparent from the detailed described given
hereinafter; it should be understood, however, the the detailed
description, while indicating preferred embodiments of the
invention, is given by way of illustration only, since various
changes and modifications within the spirit and scope of the
invention will become apparent to those skilled in the art from
this detailed description.
SUMMARY OF THE INVENTION
These objects are accomplished according to the present invention
by the provision of sterile technique tube end closures and syringe
adapters for medicosurgical tube devices which comprise a distal
end portion, a proximal end portion, a central body portion, a
removable cap for said proximal end portion and fastener strip
through which said cap is held captive to said central body
portion, all of said portions and strip being molded of plastic
material as an integral unit. The proximal end portion is
preferably of larger diameter than said distal end portion of said
central body portion is tapered from said proximal end to said
distal end. Further, the removal cap comprises a cylinder portion
of inside diameter approximately equal to the outside diameter of
said proximal end portion, a transverse top and a central plug
depending concentrically inside said cylinder portion from said top
and said plug has an outside diameter approximately equal to the
inside diameter of said proximal end. Further, the end closure
includes an encircling removable cap that is captive to the closure
body, the body and cap being cylindrical in shape.
Advantageously, the new tube end closures of the invention are
molded from semirigid or rigid polyvinyl chloride material although
they may be molded from any other suitable plastic of elastomeric
material such as synthetic rubber, polyolefins, acrylic resins, or
the like.
As a preferred embodiment of the invention, there are provided
feeding tubes equipped on the proximal end with a tube end closure
having a structure as aforesaid. As another preferred embodiment,
there are endotracheal tubes having a balloon cuff which is
inflatable through a secondary lumen and inflation tube, the
proximal end of the inflation tube being equipped with a tube end
closure and syringe adapter of the invention constructed as
aforesaid.
Objects of the invention are further accomplished through the
provision of end closures for medicosurgical tube devices that
comprise a plug of elastomeric material which is penetratable by a
syringe needle and will automatically reseal upon withdrawal of the
syringe needle, such plug being positioned distally of the proximal
end tip of the closure sufficiently so that contact of the plug
will occur only with the syringe needle when the end closure is
handled by a person attending the patient on which the
medicosurgical tube device with the end closure is associated.
Preferably, the needle penetratable plug is positioned a distance
below the proximal end of the closure at least twice the diameter
of the proximal end portion.
BRIEF DESCRIPTION OF THE DRAWINGS
For a more detailed understanding of the invention, reference is
made to the accompanying drawings in which:
FIG. 1 is a perspective view on an endotracheal tube having an
inflation tube for the balloon cuff equipped with and end closure
and syringe adapter in accordance with the invention.
FIG. 2 is a fragmentary side view partially in section of the end
closure and syringe adapter shown in FIG. 1 with the cap removed
and a Luer syringe inserted in the adapter.
FIG. 3 is an enlarged sectional view of the end closure and syringe
adapter of FIG. 1 with the encircling cap in place.
FIG. 4 is an enlarged sectional side view similar to FIG. 3 showing
an alternative form of end closure and syringe adapter in
accordance with the invention.
FIG. 5 is an enlarged end view of the cap for the end closure
looking into the cap.
DESCRIPTION OF PREFERRED EMBODIMENTS
Referring in detail to the drawings, and end closure and syringe
adapter 2 for medicosurgical tube devices, such as endrotracheal
tube 4 in accordance with the invention, comprises a distal end
portion 6, a proximal end portion 8, a central body portion 10, and
a removable cap 12. The removable cap is made captive to the
closure body by a fastener strip 14 which is molded as an integral
unit from plastic material with the cap and the closure body (see
FIG. 3).
The proximal end portion 8 is of larger diameter than the distal
end portion 6 and the central body portion is tapered beginning at
the base 16 of the proximal end portion downwardly to its
connection 18 with the base of the distal end portion 6.
In the preferred embodiment of the invention as shown in FIG. 1,
the endotracheal tube 4 has an inflatable balloon cuff 20, a
secondary lumen 22, and an inflation tube 24 joined to the proximal
end 26 of the secondary lumen through which the balloon cuff may be
inflated via the secondary lumen. The tube end closure 2 of the
invention is fixed to the proximal end 28 of the inflation tube 24.
Advantageously, the material of which the end closure 2 is molded
is semirigid polyvinyl chloride material which may be formulated to
be transparent or translucent, but which is preferably pigmented to
be opaque. The endotracheal tube 4 is fabricated initially by
extrusion of tubing sections from plasticized polyvinyl chloride
material and assembled by suitable procedures. Endotracheal tubes
or other medicosurgical tubes to which the new tube closure and
syringe adapters of the invention are applied may take any form
desired known to the art.
The end closure 2 may be fixed to the inflation tube 24 at the
proximal end 28 or to any other medicosurgical tube device to which
it may be connected with cement or adhesive, by friction welding,
by induction welding, or in any other manner known to the plastic
art for joining together two elements of plastic material. The
junction between the medicosurgical tube and the end closure may be
an overlapped joint such as shown in FIG. 3, a butt joint (not
shown) or shiplap joint (not shown).
The removable cap 12 comprises an outside cylinder portion 30
having an inside diameter approximately equal to the outside
diameter of the proximal end portion 8 of the closure 2, a
transverse top 32 and a central plug 34 depending concentrically
inside the cylinder portion 30 downwardly from the top 32. Said
plug 34 has an outside diameter approximately equal to the inside
diameter of the proximal end 8 of the closure 2.
When the removable cap is in place upon the proximal end of the
closure (see FIG. 3), the cap encircles the closure end protecting
both the outside and inside of the closure from contamination. In
addition to this protective feature of the encircling form of cap,
the cap may be easily manipulated for removal by one hand of the
person attending the patient upon which the medicosurgical tube
device is being used. Moreover, the central plug 34 of the cap 12
serves to maintain cylindrical shape in the closure body, thereby
aiding in the cap removal as required and also improving the cap
sealing function.
The closure 2 has the proximal end 8 of such size as to make a
fluidtight union (see FIG. 2) with the male connector 40 of a Luer
syringe 42. Hence, manipulation of the plunger 44 of the syringe
will give the required suction or pressure for withdrawal or
injection of liquids or other fluids through the closure 2 into the
attached tube 24. Such use of a syringe can be for inflating a
balloon cuff 20 of an endotracheal tube, introducing feeding liquid
into a feeding tube, removing or injecting fluids through a
catheter, or for any other purposes as required by the operation
being performed upon the patient.
In a preferred embodiment of the new tube closures as shown in FIG.
4, the central body portion 10 of the closure 2 is plugged with a
section 46 of soft elastomeric material that may be penetrated by a
syringe needle and will reseal upon withdrawal of the syringe
needle. Resealable elastomeric compositions of this type are known
in the art. Such resealable section is utilized in unique manner in
accordance with the invention to improve on sterile techniques in
use of medicosurgical tube devices. Thus, the top surface 48 of the
elastomeric section or plug 46 is sufficiently below the proximal
end tip 50 of the closure 2 so that accidental contact of the top
surface 48 of the plug 46 with any outside substance or member is
substantially prevented, i.e., contact will only be made
intentionally such as with a syringe needle and contact with the
finger of the arty using the device will be prevented.
Advantageously, this is attained by making the combined length of
the proximal end portion 8 and central body portion 10 of the
closure 2 at least twice the diameter of the proximal end portion 8
and the top surface 48 of the elastomeric plug 46 is below the tip
50 of the proximal end portion 8 a distance at least equal to the
inside diameter of the proximal end portion 8.
* * * * *