U.S. patent number 3,683,911 [Application Number 05/063,438] was granted by the patent office on 1972-08-15 for protective seal for catheter.
This patent grant is currently assigned to Pelam, Inc.. Invention is credited to James B. McCormick.
United States Patent |
3,683,911 |
McCormick |
August 15, 1972 |
**Please see images for:
( Certificate of Correction ) ** |
PROTECTIVE SEAL FOR CATHETER
Abstract
A device for providing a protective seal at an incision provided
incident to the insertion of a catheter beneath the skin includes a
shield having an adhesive coating on one surface so that the shield
adheres to the skin in the area of the incision to prevent bacteria
from passing beneath the shield. A tubular sleeve extends outwardly
from and is sealed to the shield to define a passageway for the
catheter, the sleeve having an inner adhesive coating to provide a
seal between the sleeve and catheter so as to prevent bacteria from
gaining access to the incision.
Inventors: |
McCormick; James B. (Hinsdale,
IL) |
Assignee: |
Pelam, Inc. (Hinsdale,
IL)
|
Family
ID: |
22049188 |
Appl.
No.: |
05/063,438 |
Filed: |
August 13, 1970 |
Current U.S.
Class: |
604/180;
128/DIG.26 |
Current CPC
Class: |
A61M
25/02 (20130101); A61M 2025/0266 (20130101); A61M
2025/0273 (20130101); Y10S 128/26 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61m 025/02 () |
Field of
Search: |
;128/348-351,133,214R,214.2,215,DIG.26 ;248/25A ;24/DIG.11 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A device for providing a protective seal at the locus of an
incision provided incident to the insertion of a catheter beneath
the skin, said device comprising
A. a shield adapted to overlie essentially the entirety of an area
of skin encircling the incision,
1. the body of said shield being formed so as to be impervious to
the passage of bacteria therethrough and being provided with an
opening located within its periphery alignable with the incision to
accommodate a catheter,
2. at least a portion of one surface of said shield being provided
with an adhesive coating effective to maintain said shield in
contact with the skin so as to prevent bacteria from passing
beneath said shield and gaining access to the incision,
B. a tubular sleeve extending outwardly from the non-adhesive
surface of said shield and sealed thereto so as to prevent bacteria
from gaining access to said opening in said shield at the juncture
of said sleeve and shield,
1. the walls of said sleeve being formed so as to be impervious to
the passage of bacteria therethrough,
2. said sleeve defining a passageway in alignment with said opening
in said shield and adapted to accommodate the catheter intimately
therein,
3. at least a portion of the inner surface of said sleeve being
provided with an adhesive coating effective to create a seal
between said sleeve and the catheter so as to prevent bacteria from
passing between said sleeve and the catheter and gaining access to
the incision.
2. A device in accordance with claim 1, wherein lateral access
means includes a cut extending from the periphery of the
catheter-accommodating opening to the outer periphery to facilitate
the placement of the shield in a position encircling a
catheter.
3. A device in accordance with claim 1, wherein said lateral access
means includes a cut extending the length of said sleeve to
facilitate the placement of the sleeve in a position surrounding a
catheter.
4. A device in accordance with claim 1, wherein said shield and
sleeve are integral, and wherein said lateral access means is a cut
which extends from the outer end of said sleeve along said sleeve
and shield to the periphery of said shield so as to facilitate the
placement of the device relative to a catheter.
5. A device in accordance with claim 1, wherein essentially the
entire inner surface of said shield and essentially the entire
inner surface of said sleeve are provided with an adhesive coating,
and wherein a removable backing sheet overlies each coating to
protect it prior to use.
6. A device in accordance with claim 1, wherein said adhesive
coating contains an antibacterial chemical.
7. A device for providing a protective seal at the locus of an
incision provided incident to the insertion of a catheter beneath
the skin, the device comprising:
A. a flat shield having top and bottom surfaces adapted to overlie
essentially the entirety of an area of skin encircling the
incision,
1. the body of said shield being formed so as to be impervious to
the passage of bacteria therethrough and being provided with an
opening located within its periphery alignable with the incision to
accommodate a catheter,
2. at least a portion of one surface of said shield being provided
with an adhesive coating effective to maintain said shield in
contact with the skin so as to prevent bacteria from passing
beneath said shield and gaining access to the incision,
B. and a tubular sleeve extending outwardly from the non-adhesive
surface of said shield and sealed thereto so as to prevent bacteria
from gaining access to said opening in said shield at the juncture
of said sleeve and shield,
1. the walls of said sleeve being formed so as to be impervious to
the passage of bacteria therethrough,
2. said sleeve defining a passageway in alignment with said opening
in said shield and adapted to accommodate the catheter intimately
therein,
3. at least a portion of the inner surface of said sleeve being
provided with an adhesive coating effective to create a seal
between said sleeve and the catheter so as to prevent bacteria from
passing between said sleeve and the catheter and gaining access to
the incision, said adhesive coating containing an antibacterial
chemical.
Description
The present invention relates to a protective seal for inhibiting
bacteria from gaining access to an incision provided incident to
the insertion of a catheter beneath the skin.
The insertion of a catheter beneath the skin of an individual to
administer parenteral fluids or to facilitate the drainage of
fluids from a body cavity or organ is not uncommon. In the majority
of instances, the catheter enters the body through an incision in
the skin, by a needle or other device, and it is not unusual for it
to remain in this position for several days or even longer. The
exposure of an incision or puncture site for such an extended
period of time renders it particularly vulnerable to infection.
It is the principal object of the present invention to provide an
improved, economical and easily applied device for providing a
protective seal at the locus of an incision provided incident to
the insertion of a catheter beneath the skin.
A related object of the invention is to provide such a device which
is effective to essentially preclude access to the incision by
infectious bacteria.
Other objects and advantages of the invention will become apparent
with reference to the following description and the accompanying
drawing.
In the drawing:
FIG. 1 is a perspective view showing a device embodying various of
the features of the invention as the device might appear on the arm
of an individual receiving an intravenous injection;
FIG. 2 is an enlarged fragmentary sectional view taken along line
2--2 of FIG. 1;
FIG. 3 is an enlarged fragmentary sectional view taken along line
3--3 of FIG. 2; and
FIG. 4 is a perspective view of the device of FIG. 1 as it might
appear before being applied at the locus of an incision.
There is illustrated in the drawing a device 11 which constitutes a
preferred embodiment of the present invention. The device is
intended to be positioned at the locus of an incision or puncture
(not shown) provided incident to the insertion of a catheter 13
beneath the skin of the arm of an individual receiving an
intravenous injection and, in this instance, an elastic band 15
holds the catheter adjacent the wrist of the individual and a tape
17 secures it to the thumb. However, it should be clear that the
device 11 is not limited to use with catheters inserted into the
arm and that it can be used in connection with catheters inserted
through the skin at various areas of the body, not only for
supplying fluids but also for the drainage of body cavities and
organs.
Basically, the device 11 includes a shield 19 having an outwardly
projecting sleeve 21 sealed thereto. The shield is adhesively
secured to the skin of the individual which encircles the incision,
and the sleeve is adhesively secured to the catheter. The adhesive
material contains a bacteriostatic or bacteriocidal chemical to
arrest the growth of or destroy any organisms present in deep pores
or sweat glands or hair follicles of the skin surface and
structure. Thus, bacteria are precluded from reaching the incision
through or under the shield or along the catheter, and those which
may be present are destroyed. The incision is thereby insulated
from a major source of infection.
The shield 19 is preferably formed of a flat sheet of a suitable
plastic such as polyethylene which is essentially air-impervious
and is thus capable of preventing bacteria-laden air from having
access to the incision. The shield is provided with an internal
opening 23 (FIG. 2) located within its periphery to accommodate the
catheter. The opening may be merely an internal hole, in which case
the shield is placed in encircling relation to the catheter by
passing one end of the catheter through the hole either before it
is inserted or, at least, before it is connected at its outer end
to a fluid supply or drainage receptacle. However, in order to
enable the shield to be placed in position relative to a catheter
previously inserted beneath the skin and connected to a fluid
supply or receptacle as, for example, to enable replacement of a
device 11 previously applied without the necessity of disconnecting
or removing the catheter, the preferred device 11 includes a cut 25
which extends from the periphery of the opening 23 to the periphery
of the shield itself. Thus, in positioning the device, the opposed
edges defining the cut 25 may be spread to facilitate placement of
the shield around the catheter and then returned to an abutting
relationship to provide the desired seal. Of course, in positioning
the shield provided with the cut 25 around the catheter 13 and
securing it to the skin, it is possible that a slight slit will be
left along the cut 25; however, it will be appreciated that ideally
there will be no slit and even if one should be present, the shield
still covers essentially the entirety of an area of skin encircling
the incision.
One surface of the shield, the lower surface as the device 11 is
viewed in the drawing, is provided with an adhesive coating 27 to
enable it to be secured or attached to that area of the skin of the
individual which encircles the incision. This coating is preferably
antibacterial in that it possesses bacteriostatic or bacteriocidal
properties which enable it to arrest the growth of or destroy any
bacteria on that portion of the skin with which it is placed in
contact. Thus, the coating may include a quaternary ammonium
complex, or any one of many antibiotics such as, for example, that
sold under the name Bacitracin by the American Pharmaceutical
Company. The thickness of this coating is exaggerated in the
drawing for clarity of illustration.
Preferably, all of the lower surface of the shield is covered so
that no passageway or route is left open through which bacteria can
gain access to the incision. However, if the shield is provided
with merely an internal opening 23 and no cut 25, it may be
sufficient to merely provide the coating 27 adjacent the outer
periphery of the shield, specifically omitting any coating adjacent
the periphery of the opening 23 to avoid placing the adhesive in
contact with the incision. If a cut 25 is provided, an additional
coating should be provided adjacent the edges of the cut. In any
event, the adhesive coating should be sufficient to maintain the
shield in contact with the skin so that bacteria will not be able
to gain access to the incision by passing beneath the shield.
The sleeve 21 extends outwardly from the periphery of the internal
opening 23. It may constitute a separate element from the shield 19
and be adapted to be adhesively secured thereto so that the shield
and sleeve may be secured in place separately around the catheter.
In the illustrated embodiment, however, the sleeve is integral with
the shield and both are formed together as one unit. This is
considered the preferred embodiment since it eliminates the
possibility of bacteria passing between the shield and sleeve
through openings which may occur through incomplete joining of the
two during the positioning of the sleeve.
The sleeve 21 is tubular in shape and defines an internal
passageway 29 to receive the catheter 13. The entire internal
surface of the passageway in the illustrated embodiment is provided
with the bacteriostatic or bacteriocidal adhesive coating 31 so
that the sleeve can be secured to the outer surface of the catheter
in such a manner as to prevent bacteria from gaining access to the
incision through the passageway 29. However, in some instances, it
may not be necessary to provide an adhesive coating in the area of
the passageway immediately adjacent the incision, and it may be
desired to terminate the coating 31 short of that end of the sleeve
which is immediately adjacent the incision. A removable backing
sheet 32 of plastic or the like is preferably maintained in contact
with the coating 31 of the sleeve and with the coating 27 of the
shield to prevent these coatings from becoming attached to material
other than the catheter or skin prior to the actual placement of
the device around the catheter.
The internal diameter of the passageway 29 preferably corresponds
closely to the outer diameter of the catheter to insure an intimate
engagement between the two. To facilitate placement of the sleeve
around the catheter, the sleeve is provided with a cut 33 which
enables a wall of the sleeve to be opened to receive the catheter
and eliminates the difficulty of inserting the catheter
longitudinally through the sleeve when the inner surface of the
sleeve is provided with an adhesive coating. When the shield is
also cut, both cuts 25 and 33 are preferably in alignment (FIG.
3).
It would be possible to merely coat the upper portion of the inner
surface of the passageway 29 with adhesive and to then fold this
coated portion back upon itself, placing the adhesive on the
outside of the sleeve. The catheter could then be easily inserted
longitudinally through the passageway 29 and, subsequently, the
upper portion of the sleeve unfolded to place the adhesive in
contact with the catheter.
In the use of the device 11 of the illustrated embodiment, the
catheter 13 is preferably inserted beneath or through the skin in
the usual manner and suitably connected to a supply of parenteral
fluid or to a drainage receptacle as the situation dictates. Prior
to forming the incision or puncture for insertion of the catheter,
the skin is normally sterilized by means of a suitable reagent, but
it may also be desirable if conditions permit to shave the skin
surrounding the area where the incision or puncture is to be made
to insure complete adherence to the skin by the shield 19. The
device 11, which ideally is distributed in a sealed envelope, is
then unwrapped and the protective sheet 32 is removed from the
adhesive coatings 27 and 31 on the outer surface of the shield 19
and the inner surface of the sleeve 21. The wall of the sleeve, and
the shield, are spread along the cuts 33 and 25, respectively, and
the device is placed around the catheter 13 immediately adjacent
the incision where the catheter penetrates the skin. The shield is
then secured to the skin by means of the bacteriostatic or
bacteriocidal adhesive coating 27, with the edges defining the cut
25 in abutting or overlapping relation, and the sleeve is secured
to the catheter 13 with the edges defining the cut 33 also in
abutting or overlapping relation.
When the device 11 is properly positioned, the shield 19 is sealed
to the skin and precludes access to the incision by bacteria except
through the internal opening 23. The sleeve, on the other hand, in
addition to supporting the catheter, is sealed to the catheter and
prevents access to the incision through the opening 23 as well as
along the outer surface of the catheter 13. The device 11 not only
serves to protect the incision, but is secured in place in such a
manner as to prevent the displacement of the device incident to the
normal movements of the individual. Assuming that the device is
applied in a relatively sterile field and includes an antibacterial
adhesive, infection of the incision is greatly minimized.
While one of the specific embodiments of the deice 11 has been
shown and described, it should be apparent that various
modifications may be made therein without departing from the scope
of the invention. Such modifications include the forming of the
shield and sleeve as separate parts, the provision of an adhesive
coating on less than an entire surface of the shield and/or sleeve,
and the elimination of the cuts in the shield and sleeve if it is
desired to place them on the catheter before the catheter is both
inserted in the body and connected at its opposite end, as to a
supply of fluid or to a drainage receptacle.
Various of the features of the invention are set forth in the
following claims.
* * * * *