U.S. patent number 3,680,562 [Application Number 05/137,550] was granted by the patent office on 1972-08-01 for surgical drainage apparatus for bladder.
This patent grant is currently assigned to Becton, Dickinson and Company. Invention is credited to Peter J., Bonanno, James M. Wittes.
United States Patent |
3,680,562 |
Wittes , et al. |
August 1, 1972 |
SURGICAL DRAINAGE APPARATUS FOR BLADDER
Abstract
A surgical apparatus for delivering fluids to or withdrawing
fluids from the bladder includes a catheter having an inwardly
curved, tapered blunt-tip with a series of longitudinally aligned
ports spaced on the inside of the curve. A removable piercing
element is disposed within the catheter having a beveled point
extending beyond the end of the plastic tube. A pliant sheath,
tightly fit over the catheter tube, is bifurcated at its distal end
into half-tube branches which are adapted to be bent away from the
catheter tube after introduction of the assembly into the body to
anchor the apparatus to the skin. In order to provide further
control over the position of the catheter tubing in the bladder the
bifurcated anchoring wings are in a mutually perpendicular plane to
the outlet ports.
Inventors: |
Wittes; James M. (Linden,
NJ), Bonanno; Peter J., (Tenafly, NJ) |
Assignee: |
Becton, Dickinson and Company
(East Rutherford, NJ)
|
Family
ID: |
22477933 |
Appl.
No.: |
05/137,550 |
Filed: |
April 26, 1971 |
Current U.S.
Class: |
604/500; 604/174;
604/541 |
Current CPC
Class: |
A61M
25/02 (20130101); A61M 25/0606 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61M 25/02 (20060101); A61b
017/34 (); A61m 025/00 () |
Field of
Search: |
;128/214.4,221,347,348,349R,35R,351 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. A surgical catheter assembly for draining or delivering fluids
to the bladder comprising:
a. a hollow, flexible plastic tube of suitable diameter for
insertion into the bladder, said tube having a tapered blunt tip at
the distal end thereof, said tube being inwardly curved at the
distal end when unobstructed, said tube having a series of
longitudinally aligned ports spaced on the inside of said
curve;
b. a rigid hub in open communication with the lumen of the plastic
tube in sealing engagement with the proximal end of the tube;
c. a hollow, piercing element removably disposed within said
plastic tube, said element having a beveled point extending beyond
the distal end of said plastic tube, wherein the tapered blunt tip
of said tube is in close friction fit with the piercing
element;
d. means for indicating the presence of fluid in the piercing
element after insertion into the bladder; and
e. a pliant sheath sealingly fitted about the proximal end of the
catheter tubing, said sheath bifurcated at its distal end into
anchoring wings adapted to be bent away from the catheter tube
after introduction of the assembly into the bladder to form an
anchor for the assembly.
2. The invention in accordance with claim 1 in which the piercing
element comprises a needle extending beyond the blunt tip of the
catheter tube at its distal end and having a hollow light-pervious
hub in fluid communication with the proximal end of said catheter
tube.
3. The invention in accordance with claim 2 including a vent plug
removably engaged in said needle hub for blocking the flow of fluid
through said needle during insertion of the assembly into the
bladder and for permitting the passage of air through said needle
during such insertion.
4. The invention in accordance with claim 1 in which said
bifurcated wings are in preselected alignment with said outlet
ports for proper orientation of the distal end of the catheter
tubing in the bladder.
5. A suprapubic method for inserting the catheter assembly of claim
1 into the bladder comprising, in sequence, the steps of:
a. distending the bladder with nontoxic fluid,
b. inserting the catheter assembly through the abdominal wall into
the bladder for approximately one half the distance between the
distal end of the catheter tubing and the bifurcation point of the
sheath,
c. verifying the presence of said assembly in the bladder,
d. withdrawing the piercing element while introducing the catheter
tubing into the bladder until the bifurcation point on the sheath
is reached, and
e. affixing each of said wings to the skin.
Description
BACKGROUND OF THE INVENTION
The invention relates to a catheter assembly, and in particular, to
a catheter assembly which can be introduced into the bladder with
minimal trauma.
In the past a number of catheter units of one form or another have
been introduced commercially. A catheter unit having received
acceptance, features an assembly including a piercing element, in
some instances a conventional hypodermic needle, and a plastic
catheter tube engaging the walls of the needle and so arranged with
respect thereto that both are adapted to be introduced into the
skin. When the desired degree of penetration has occurred, the
needle and catheter tube are respectively shiftable whereby the
needle is withdrawn with respect to the catheter tube which, under
such circumstance, will remain situated for the intended
catheterization purpose. Catheter needles accorded a high degree of
commercial acceptance for this purpose are disclosed in U.S. Pat.
No. 3,406,685 and U.S. Pat. No. 3,469,579. Other indwelling
catheters are illustrated in U.S. Pat. No. 3,419,010 and U.S. Pat.
No. 3,312,220.
Recently, the medical profession has recognized the desirability of
suprapubic catheterization following gynecological surgery instead
of employing the traditional Foley catheter. It has been postulated
that traditional bladder catheterization through bacteria-laden
exterior reproductive apparatus represents a greater infection
hazard than traversing the more easily cleansed abdominal skin and
sterile abdominal wall. General and specialized technique catheter
needles known to the art as, for example, the needles described in
the above-identified patents, are not adapted for this function as
certain unique problems are presented. A suprapubic catheter for
bladder drainage must be provided with anchoring means for the
indwelling period, wherein the anchoring means does not create a
germ trap and concomitant source of infection. The distal end of
the catheter inserted into the bladder must resist expulsion
through the urethra. Outlet ports on the distal end of the catheter
must resist occlusion by the bladder mucosa during the indwelling
period. Indexing means must be provided to determine orientation of
the distal end of the catheter within the bladder and to indicate
satisfactory penetration of the catheter needle in the bladder
during introduction.
SUMMARY OF THE INVENTION
It is, therefore, a primary object of the invention to provide an
indwelling catheter apparatus for suprapubic insertion into the
urinary bladder.
It is another object of the invention to provide a catheter
apparatus adapted to drain the bladder which resists expulsion from
the bladder and occlusion by the bladder mucosa.
It is an additional object of the invention to provide suprapubic
catheter apparatus with indexing means to indicate proper insertion
and orientation in the bladder.
The above and other objects are obtained in a surgical catheter
drainage apparatus for the bladder, the apparatus including a
flexible plastic tube inwardly curved at the distal end with a
tapered, blunt tip and a series of longitudinally aligned outlet
ports spaced on the inside of the curve at the distal end of the
tube. Within the tube is disposed a hollow piercing element having
a beveled point which extends beyond the distal end of the tube,
wherein the tapered blunt tip of the tube provides a close fit with
the piercing element. A pliant sheath, bifurcated at its distal end
into half-tube branches, is tightly fitted over the proximal end of
the plastic tube. The proximal ends of the piercing element and
tube are each affixed to a rigid hub, the hubs adapted to
interlock. At least a portion of the hub of the piercing element is
pervious to light.
The above assembly is inserted through the skin into the bladder
and, when properly positioned, the piercing element is removed as
the catheter tubing is inserted into the bladder. The bifurcated
wings of the sheath provide the anchoring means for the indwelling
catheter. The tightly fitted sheath precludes the formation of a
germ trap. As the piercing element is withdrawn from the catheter
tubing, its distal end assumes a preformed coil or curve. The
springiness of the coil prevents the catheter from injuring the
body cavity walls as the catheter changes shape. Since the catheter
tip is located within the coil, it is prevented from working itself
into any natural passages or orifices leading from the cavity. The
catheter can uncoil or coil to adapt to changes in the distance
from the skin to which the catheter is anchored and the cavity wall
through which it passes.
The spacing of the catheter ports on the inside of the coil permits
unimpeded introduction of the piercing element into the catheter
lumen and avoids occlusion by the bladder mucosa. The
light-pervious element hub allows identification of fluids passing
through the element as the assembly is introduced into the
body.
BRIEF DESCRIPTION OF THE DRAWINGS
Other objects and advantages will become apparent from the
following detailed description of the invention which is to be
taken in conjunction with the accompanying drawings illustrating
several preferred embodiments of the invention and in which:
FIG. 1 is an exploded elevational view of the piercing element and
indwelling catheter with a gripping shield over the catheter for
insertion of the piercing element and a ribbed vent plug for the
hub of the piercing element;
FIG. 2 is an elevational view of the catheter assembly of the
invention including the gripping shield and vent plug;
FIG. 3 is an enlarged sectional view of the catheter assembly
including a vent plug;
FIG. 4 is an enlarged view, partially in section, of the distal end
of the catheter tubing;
FIG. 5 is an enlarged elevational view of a catheter tubing in the
coiled position after removal of the piercing element; and
FIG. 6 is a schematic diagram of the indwelling catheter with the
piercing element removed representing the position of the catheter
within the bladder.
As illustrated in FIG. 1, the catheter needle assembly of the
invention includes a piercing element such as a hollow puncture
needle 10 having a beveled point 12 at the distal end and a
light-pervious hub 14 at the proximal end. The tubular shank 16 of
the needle is of a selected gauge, for example, 18 gauge, to
facilitate ready insertion through the skin into the bladder. An
air dent surface 20 is provided to indicate the depth of
penetration of the needle into the body.
The hub 14 of the puncture needle or cannula 10 is fabricated from
translucent and, preferably, transparent rigid material, such as a
polycarbonate plastic. As the catheter assembly is inserted into
the bladder, proper penetration may be insured by observing the
presence of fluids in the hub. During insertion vent plug 22
engages hub 14 to prevent escape of contaminated body fluids into
the sterile catheterization field. As illustrated in FIG. 3, shank
16 is securely bonded to the bore 18 of hub 14 with epoxy resin. If
desired, the shank may be swedged within the hub according to
conventional techniques.
For aspiration and other purposes, it is desirable that proximal
end 24 of hub 14 have a Luer-Lok type fitting. Distal end 26 of hub
14 is tapered and adapted to frictionally engage hub 30 of catheter
32.
Indwelling catheter 32 comprises hollow, smooth, flexible plastic
tubing 28 and hub 30. The tubing is preferably fabricated from a
transparent polymerized olefin resin, such as tetrafluoroethylene
(Teflon) resin, or, more preferably, a fluorinated ethylene
propylene resin. The catheter tubing has a penetrating tip, tapered
onto penetrating needle shank 16 to prevent collapse of the tubing
during insertion into the bladder. As illustrated in FIG. 3, a
portion of the shank 16 and beveled point 12 of the piercing needle
extends beyond the blunt end 34 of the catheter tubing to
facilitate insertion.
Turning now to FIGS. 4 and 5 it is seen that the catheter tubing 28
terminates in an inward pigtail curve. The distal end of the tubing
is pre-formed to have a coil memory. The end of the unobstructed
coiled tip 34 of the tubing forms an angle .alpha. of preferably
from about 30.degree. to 45.degree. with the adjacent straight
portion of the catheter tubing.
To facilitate withdrawal or introduction of fluids into the bladder
a series of longitudinally aligned ports 36 are spaced on the inner
portion of the pigtail curve. Such placement prevents kinking of
the tubing and permits unimpeded introduction of the cannula 10
into the catheter lumen. Further, the placement avoids occlusion of
the ports by bladder mucosa.
The proximal end of the catheter tubing is affixed in permanent
fluid communication to hub 30. A leak-proof, permanent and strong
connection is formed between catheter tubing 28 and hub 30. A
satisfactory method for forming the connection is disclosed in U.S.
Pat. No. 3,469,579. If desired, the tubing can be affixed to the
hub by conventional riveting or swedging techniques. The catheter
hub is fabricated from a rigid plastic material, such as
polypropylene. For drainage pruposes, it is particularly preferred
that the catheter hub have a Luer-Lok type fitting.
Turning now to FIGS. 1 and 2, in order to provide an anchoring
means for the indwelling catheter, a pliant sheath 38, bifurcated
into half-tube wings 40, 40' at its distal end, is fitted over the
catheter tubing. After the catheter tubing is implanted within the
bladder, the bifurcated wings are bent away from the catheter tube
and affixed to the skin to anchor the indwelling catheter. The
wings may be anchored to the skin with silk sutures. In order to
provide a means for properly orienting the catheter coil in the
bladder, the bifurcated wings are aligned in a plane perpendicular
to the plane passing through outlet ports 36. Thus, the orientation
of the coil and outlet ports within the bladder can be determined
merely by observing the bifurcated wings affixed to the skin, since
the plane passing through the coil and outlet ports will be
oriented 90.degree. from the plane in which the wings are
spaced.
The pliant sheath is preferably fabricated from a flexible,
heat-shrinkable, plastic resin such as the aforementioned
tetrafluoroethylene resin, or, more preferably, a polyolefin
material, such as Penntube V vinyl resin. The length of the sheath
and the extent of bifurcation are preselected such that the
precoiled catheter tubing is fully implanted within the bladder. A
workable catheter for this purpose has an eleven inch catheter tube
with a 4 inch sheath shrunk fit about the proximal end of the
catheter tubing, said sheath having a 1 inch bifurcation at the
distal end.
The tight fit between the sheath and catheter tubing prevents fluid
and/or blood seepage therebetween. Undesired blood or fluid seepage
results in the formation of a germ trap between the sheath and
catheter tubing, thereby promoting infection at the catheter
insertion site. To assemble the sheath over the catheter tubing,
the sheath is slipped over the distal end of the tubing and onto
the lower portion 42 of hub 30. Thereafter the sheath is shrunk fit
about the tubing and hub by suitable heating means such as an
autoclave or an oven.
In order to assemble the catheter apparatus prior to insertion into
the bladder, a tubular shield 44 is introduced over the catheter
tubing. The shield provides a gripping surface during insertion of
the piercing needle 10 into the catheter 32 and prevents
contamination of the catheter tubing through handling. The shield
is of slightly greater diameter than the catheter tubing and forms
a slidable friction fit with the tubing. As shown in FIG. 3
piercing needle 10 is inserted into catheter 32 until needle hub 14
is firmly seated in catheter hub 30 and beveled point 12 of needle
10 protrudes from the distal end 34 of catheter tubing 28.
In order to prevent fluids from escaping from the proximal end 24
of hub 14 during insertion of the catheter assembly into the body,
vent plug 22 is provided. Plug 22 has a series of spaced ribs 23
which are adapted to be force-fit into needle hub 14. The ribs
allow air to pass through the cannula 10 during insertion, but
prevent the passage of fluids.
In order to insert the catheter apparatus into the bladder, the
bladder is initially distended with sterile saline or other
suitable fluid. Next, with the gripping shield removed, the
catheter assembly is thrust through the abdominal wall about half
the distance between the needle point 12 and the bifurcated wings
40, 40', as indicated by air dent surface 20. The preferred clear,
fluorinated ethylene propylene catheter tubing allows the operator
to follow the movement of air dent 20 at all times. The presence of
clear fluid in light pervious hub 14 verifies the presence of the
catheter tip in the bladder. Occasionally it may be necessary to
aspirate the apparatus with a syringe.
When the catheter is within the bladder, the cannula is disengaged
and gradually withdrawn, while the catheter is simultaneously
introduced up to the point of bifurcation in the sheath.
Thereafter, the bifurcated wings are anchored to the skin with
sutures or the like as illustrated in FIG. 6.
To drain the bladder, catheter hub 30 is interengaged in fluid
communication with an adapter (not shown) having a male luer
fitting and a female luer fitting. The adapter is connected to a
plastic drainage bag or the like by conventional tubing having
clamping means.
Various embodiments of the invention will be obvious to those
skilled in the art. A trocar with a light-pervious hub may be
employed in combination with a fitted, pointed stylet for piercing
element 10 and vent plug 22, with less satisfactory results,
however. Such an assembly would be more awkward to use and more
expensive to fabricate than the catheter assembly hereinbefore
described. If desired, a LONGDWEL obturator may be inserted into
the catheter tubing to plug the lumen during manipulation of the
adapter.
Having thus described the preferred embodiment of the invention, it
is not intended to be limited except as set forth in the following
claims:
* * * * *