U.S. patent number 3,568,679 [Application Number 04/774,662] was granted by the patent office on 1971-03-09 for catheter placement unit.
This patent grant is currently assigned to Dow Corning Corporation. Invention is credited to James R. Reif.
United States Patent |
3,568,679 |
Reif |
March 9, 1971 |
CATHETER PLACEMENT UNIT
Abstract
A unit for retaining a catheter in a desired place within a body
is disclosed. A thin disc of flexible material, preferably silicone
rubber, is adhesively secured to any desired external surface of a
body. If the surface has already been punctured, a desirable
catheter is then introduced into the body through an aperture in
the disc, otherwise a trocar can be used to puncture the surface
and introduce the catheter into the body. When the catheter has
been placed in the desired position, it is then locked in place by
a locking device affixed to the disc.
Inventors: |
Reif; James R. (Midland,
MI) |
Assignee: |
Dow Corning Corporation
(Midland, MI)
|
Family
ID: |
25101878 |
Appl.
No.: |
04/774,662 |
Filed: |
November 12, 1968 |
Current U.S.
Class: |
604/180;
128/DIG.26 |
Current CPC
Class: |
A61M
25/02 (20130101); A61M 2025/0266 (20130101); A61M
2025/024 (20130101); Y10S 128/26 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61m 025/02 () |
Field of
Search: |
;128/348--351,133 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. In a catheter placement unit wherein a catheter is to be
inserted into an opening into the body of a patient, transversely
through an aperture in a flexible disc adapted to be placed over
said opening for preventing infection in said opening and the
deposition of body fluids from said opening onto the body of said
patient, said disc having a first surface adapted to be adhesively
adhered to said body of said patient and a second surface having
means whereby said catheter is locked in a desired position, the
improvement in said means for locking said catheter which
comprises:
a block of substantially semirigid material affixed to said second
surface of said disc and substantially coextensive with an entire
diameter of said disc, said block having first and second portions
separated by said aperture through said disc and defining a cleft
around said aperture, said first and second portions having a
passageway therethrough substantially parallel to the portion of
said second surface to which said block is attached, which
passageway is substantially equal in diameter to the outer diameter
of said catheter, said first and second portions further having a
slit narrower than the diameter of said passageway extending
substantially radially away from said passageway in a direction
substantially parallel to the portion of said disc to which said
block is attached and through an external edge of said block along
the full length of said passageway.
2. The catheter placement unit as defined in claim 1, wherein said
block and said disc are made from a silicone rubber.
Description
Background of the Invention
The present invention relates to the field of surgical appliances,
and more particularly, to catheters and their proper placement.
Catheters of many sizes, shapes and designs have long been used in
the bodies of humans and other animals to permit injection or
withdrawal of fluids. A problem occurs with catheters being so used
in that either they can slip out of the body thereby stopping the
desired injection or draining, or they can be drawn into the body
thereby causing damage to body tissue and frequently necessitating
surgery for their removal.
Accordingly, many devices for a proper placement or retention of a
catheter have been developed. Some of these devices include
balloons attached to the distal end of a catheter, wings or barbs,
hooks, tape, sr straps or belts, and even safety-pins.
For various reasons, some persons are not able to urinate in a
natural or normal manner. The usual method of enabling such persons
to void their bladders is by use of a Foley catheter-- a commonly
used name for a balloon or bulb retention catheter. Generally, the
Foley catheter is inserted through the urethra of the patient into
the bladder, and the balloon is then inflated to hold the catheter
in place.
It is widely reported in the medical journals, that such use of a
Foley catheter causes much discomfort for the patient. If the Foley
catheter is needed for any extended period of time, serious tissue
irritation in both the bladder and urethra can occur, and the
catheter frequently becomes occluded by such body residues as
clotted blood, lymph and bladder stones. Frequent recatherization
therefore is required, adding more discomfort for the patient.
Further, studies have shown that the Foley catheter introduces
infection. Indeed, one such study found that 98 percent of the
patients who use a Foley catheter for four or more days of constant
urinary drainage have bacteriuria of a significant amount. This
fact is particularly important for the female patient following
vaginal repair, where the patient's hygiene is extremely
important.
Still another disadvantage of the Foley catheter is that the
patient cannot use normal urinating procedure while the catheter is
in place in the urethra. Thus, due to lack of use, nearly 100
percent of all patients cannot naturally urinate after the first
removal of the catheter. Thus, recatherization is necessary, and in
nearly 50 percent of all cases, recatherization takes place a
minimum of three times before the patient can urinate
naturally.
Accordingly, doctors and medical researchers have turned to other
methods of maintaining bladder decompression. Recently, several
doctors have developed a suprapubic cystotomy system. In one study
at the University of Nebraska, suprapubic cystotomies using
polyethylene tubing for continuous postoperative urinary drainage
were performed in 37 patients having vaginal plastic procedures.
The patients with cystotomies required three days less continuous
urinary drainage and three days less hospitalization than a control
group of patients managed with indwelling Foley catheters. The
incidence of bacteriuria among these patients was reduced to 19
percent.
Briefly stated, suprapubic cystotomies for urinary drainage are
performed by locating the patient's bladder from the exterior,
puncturing the skin, flesh and bladder with a needle and
introducing a catheter into the bladder through that puncture. A
suitable adapter is then placed in the a catheter and a tube
attached thereto having its distal end placed in a drainage bag for
continual urinary collection.
The patient is encouraged to drink fluids and is given sitz baths
on the first postoperative day. The patient is encouraged to void
while in the sitz bath, thus enabling the patient to urinate
naturally, or at least attempt to do so, while the catheter still
is in place in the bladder. After voiding 50--100 ml. on two or
three occasions, the catheter is removed, and no further
catherizations are required.
The suprapubic cystotomy requires a better catheter placement or
locking device than has been available prior to the present
invention. Some doctors have merely sutured the cystotomy catheter
to the skin of the patient, while other have taped the catheter to
the skin. Consequently, some patients have had the catheter fall
out of the bladder, while other patients have passed the catheter
through the urethra while voiding, because the catheter was not
adequately locked in place. When too much of the catheter works its
way into the bladder, tissue damage can occur. If the catheter
works free of the tape and adapter and is completely drawn into the
bladder but not passed through the urethra, surgery is required to
remove it. Additionally, skin irritation can be caused by the tape
used to secure the catheter.
Summary of the Invention
The primary object of the present invention, therefore, is to
provide an improved catheter placement unit which will be free from
the aforementioned and other disadvantages of prior devices of this
type.
More particularly, it is an object of the present invention to
provide a catheter placement unit capable of retaining a catheter
at a desired position in a body by locking the catheter into a
locking means on the external surface of the body.
Another object is to provide a catheter placement unit which is
capable of preventing body fluids from being deposited on the skin
surrounding the puncture or opening made in the skin and flesh
prior to the insertion of the catheter.
Still another object is to provide a catheter placement unit
capable of protecting the puncture wound from external
infection.
In accordance with these and other objects, there is provided by
the present invention a thin disc which is adhesively secured to a
body at the spot where a catheter is desired to be inserted. A
trocar can then be used to introduce the catheter to some desired
location in the body through the disc. The trocar is then removed
from the body, and catheter is locked securely into the locking
means affixed to the disc.
The locking means affixed to the disc consists of a block of
substantially semirigid material which has an aperture or
passageway through it in a direction substantially parallel to the
portion of the disc to which the block of material is affixed. A
slit extends radially from the aperture, along its full length,
through an external edge of the block. The catheter is locked in
place by forcing it through the slit until it reaches the aperture,
whereupon the semirigid material closed around the catheter,
locking it securely in place.
Thus, the catheter is securely locked into place by the locking
means affixed to the disc, and the body is protected by the disc
from having body fluids deposited on the skin surrounding the
puncture or opening made in the skin and flesh prior to the
insertion of the catheter. Likewise, the puncture wound is
protected by the disc from external infection or irritation.
Brief Description of the Drawings
Other objects and many more attendant advantages will become
obvious to those skilled in the art by reading the following
detailed description in connection with the accompanying drawings
wherein:
FIG. 1 is a view in elevation of a trocar usable in one embodiment
of the present invention showing the head thereof in cross
section;
FIG. 2 is a view in elevation of a catheter usable in one
embodiment of the present invention;
FIG. 3 is a top plan view of the disc of the present invention
showing one embodiment of the locking means affixed thereto;
FIG. 4 is a view in elevation of the disc of FIG. 3;
FIG. 5 is a top plan view of the disc of the present invention
showing another embodiment of the locking means affixed
thereto;
FIG. 6 is a view in elevation of the disc of FIG. 5;
FIG. 7 is a top plan view of the disc of the present invention
showing another embodiment of the locking means affixed
thereto;
FIG. 8 is a view in elevation of the disc of FIG. 7;
FIG. 9 is a view partially in cross section showing the catheter
placement unit of the present invention being inserted into the
bladder of a human; and
FIG. 10 is a view partially in cross section showing a catheter
locked in a desired position within a human bladder by an
embodiment of the placement unit of the present invention.
Description of the Preferred Embodiments
Referring now to the drawings, wherein like reference numerals
designate like or corresponding parts throughout the figures
thereof, there is shown in FIG. 1 a trocar, shown generally as 11,
having a hollow shaft 13 with a pointed tip 15 suitable for
puncturing the skin and flesh of humans and other animals. The
trocar preferred by applicant has a head tapered inwardly from the
top and having a groove 17 in which a catheter can be accommodated.
The trocar does not have to be hollow, but it must be capable of
introducing a desired catheter into a body.
A catheter 21 made of a flexible material and having small holes 23
at one end is shown in FIG. 2. The holes enhance the injection or
withdrawal of fluids from a body, but a catheter without such holes
in the sidewalls may also be used. For most applications, a
silicone rubber catheter has been found to produce the best results
in terms of patient comfort and continue operability. That is, a
silicone rubber catheter has been found to plug up less often than
catheters of other materials and to cause less tissue irritation
than other catheters. When a hollow trocar is used, the catheter 21
must have an outer diameter less than the inner diameter of the
shaft 13 so that the catheter may be introduced through the shaft
13 into the body. However, a rodlike trocar having a catheter
ensleeved about it can also be used as the means of introducing the
catheter into the body.
Further, while a particular catheter 21 has been shown, it is to be
understood that any type or design of catheter desired may be used
within the spirit of the present invention. Likewise, if a wound or
opening already exists in the body, the catheter obviously can be
inserted therein without the use of a trocar.
In FIG. 3, there is shown a thin, flexible disc 25 having an
aperture 27 therethrough and a block of a substantially semirigid
material 29 affixed thereto. The disc is flexible so that it can
readily conform to the surface of the body on which it will be
adhesively secured. Further, the disc is preferably made from a
silicone rubber, which in addition to being nonirritating to the
skin, can be made clear to allow for inspection of the wound site.
Although the word "disc" is generally understood to mean a circular
object, within the scope of this invention, the word "disc" will
also be used to mean ovals, squares, rectangles and other
polygons.
The function of the aperture 27 is to receive the trocar 11 and the
catheter 21 when they are introduced into the body. Although the
aperture 27 is preferred, it is obvious that a disc 25 not having
such an aperture 27 can be used if the disc is made from material
which can be punctured by the trocar 11. Preferably, the disc 25 is
made from a silicone rubber, since that material allows the covered
skin to breathe by allowing vapors to diffuse through it.
The block of substantially semirigid material 29 is the locking
means by which a catheter 21 can be locked into a desired position.
An aperture or passageway 31 passes through the block 29 in a plane
substantially horizontal to the surface of the disc 25 to which the
block is affixed. This aperture 31 must have a diameter equal to,
or slightly smaller than, the outer diameter of the catheter 21, if
the catheter 21 is to be locked securely therein.
As can be seen in FIG. 4, there is a slit 33 extending
substantially radially from the aperture through an external wall
of the block 29. The slit 33 runs the full length of the aperture
31 and can extend in any direction as long as it will emerge from
the block at a place other than where the block is affixed to the
disc 25. When it is desired to lock the catheter in place, the
block of semirigid material 29 is forced open along the slit 33,
and the appropriate portion of the catheter 21 is force through the
slit 33 until it reaches the aperture 31. The slit 33 is then
allowed to close, thereby securely locking the catheter 21 in
place.
The block of semirigid material 29 can be adhesively secured to the
disc 25 by a suitable adhesive, or the entire disc 25 and block 29
can be molded as one piece. Obviously, the aperture 31 can be
drilled through the block 29 and the slit 33 made therein either
before or after it has been affixed to the disc. The semirigid
material 29 must be rigid enough to prevent the catheter from being
easily pulled out of the aperture 31, but must have some
flexibility so that the slit 33 can be forced open to allow the
catheter to enter the aperture 31.
Variations of the locking means 29 as shown in FIGS. 5--8. The
aperture 27 through the disc also passes through the block of
semirigid material 29 in each of these variations. Also, the
locking means or block 29 extends along an entire diameter in each
of the embodiments shown in FIGS. 5 and 7, thus allowing the
catheter 21 to be locked in either of two directions when location
of attached equipment or other considerations, such as skin
irritation, require. Further, each end of these blocks tapers
inwardly at a 45.degree. angle from the surface of the disc 25.
The slit 33 extends substantially radially from the aperture or
passageway 31 in a direction substantially perpendicular to the
disc 25 in the embodiment shown in FIG. 5 and FIG. 6. The slit 33
in the embodiment shown in FIGS. 7 and 8 extends from the aperture
or passageway 31 in a direction substantially horizontal to the
disc 25. The locking means 29 shown in FIG. 7 has a portion cut
away in the area 35 surrounding the aperture 27 through the disc.
Thus, the block 29 defines a cleft or valley around the aperture
27, which cleft facilitates handling of the catheter 21 while it is
being locked into place.
One use of a specific embodiment of the catheter placement unit of
the present invention is in a suprapubic cystotomy as illustrated
in FIGS. 9 and 10. The bladder 41 of a human, shown partially cut
away, is distended by the insertion of 300--400 cc. of a saline
solution therein through the urethra, using a urethral catheter, or
the like. The bladder 41 may then readily be located by probing the
external surface of the body 43.
When the proper site for puncturing the body 43 has been located, a
sterile medical grade silicone adhesive is applied to both the skin
of the body 43 at that site and the appropriate surface of the disc
25. Preferably, the adhesive used is Medical Adhesive-B sold by the
Dow Corning Corporation, Midland, Michigan, and it may be applied
by either spraying or swabbing of the desired amount.
The disc 25, made from a silicone rubber, having a diameter of
three inches, a thickness of .035 inches and an aperture 27 with a
diameter of .078 inches through its center is then applied to the
skin 43. The aperture 31 through the block 29 has a diameter of
.093 inches, and the slit 33 has a width of .062 inches.
A trocar 11 made from a stainless steel tube having an outer
diameter of .134 inches and an inner diameter of .114 inches and a
length of 31/2 inches is then advanced through the aperture 27 in
the disc 25 and into the bladder 41. A catheter 21, made from a
silicone rubber, is threaded through the trocar shaft and into the
bladder 41, as shown in FIG. 9. The catheter 21 has a length of 12
inches, an outer diameter of .110 inches and an inner diameter of
.050 inches.
Then the trocar 11 is removed from the bladder 41 and the disc 25,
and the catheter 21 is forced through the slit 33 until it reaches
the aperture 31 in the semirigid block 29. Thus, as can be see in
FIG. 10, the catheter 21 is locked in a desired place within the
bladder 41 by the locking means 29 affixed to the disc 25. Further,
the skin of the body 43 has been protected from body fluids
excreted from the body prior to the is insertion of the catheter 21
into the puncture wound, and the puncture wound continues to be
protected by the disc from external infection or irritation.
Obviously, the catheter placement unit as described herein has uses
other than in the suprapubic cystotomy system described above. Some
of these other uses include relief of pneumothorax, applying
artificial pneuomothorax, drainage of fluid accumulations, caudal
anesthesia, pleural punctures and feeding tubes.
Having now described the invention in specific detail and
exemplified the manner in which it may be carried into practice, it
will be readily apparent to those skilled in the art that
innumerable variations, applications, modifications and extensions
of the basic principles involved may be made without departing from
its spirit or scope.
* * * * *