U.S. patent number 3,698,396 [Application Number 05/095,012] was granted by the patent office on 1972-10-17 for catheter assembly for peritoneal cavity insertion.
This patent grant is currently assigned to Abbott Laboratories. Invention is credited to Dean R. Katerndahl, Fidel V. Macalalad, Gene C. Ring, Earl D. Wilson.
United States Patent |
3,698,396 |
Katerndahl , et al. |
October 17, 1972 |
CATHETER ASSEMBLY FOR PERITONEAL CAVITY INSERTION
Abstract
A catheter assembly for peritoneal insertion, including an
elongated stylet, an elongated catheter slidably disposed around
the stylet and a gripping member secured to a proximal end of the
stylet and having a handle grip extending transversely therefrom
adjacent a shank of the stylet such that the handle grip may be
grasped in the palm of one hand with the fingers grasping the
catheter adjacent a distal end thereof whereby the catheter
assembly may be firmly held and guided with one hand during
peritoneal cavity insertion. Various embodiments of the catheter
assembly include an elongated barrel surrounding the catheter
having a closed end anchored to the proximal end of the stylet, a
stylet which is bent upon itself to form the gripping member, and a
gripping member disposed parallel to the shank of the stylet and
having an upper end bent upon itself and secured to the proximal
end of the stylet.
Inventors: |
Katerndahl; Dean R. (Wheaton,
IL), Wilson; Earl D. (Ingelside, IL), Macalalad; Fidel
V. (Lake Forest, IL), Ring; Gene C. (Libertyville,
IL) |
Assignee: |
Abbott Laboratories (North
Chicago, IL)
|
Family
ID: |
22248593 |
Appl.
No.: |
05/095,012 |
Filed: |
December 4, 1970 |
Current U.S.
Class: |
604/164.01 |
Current CPC
Class: |
A61M
25/06 (20130101) |
Current International
Class: |
A61M
25/06 (20060101); A61b 017/34 (); A61m
025/00 () |
Field of
Search: |
;128/213,214.4,215,221,303,347,348,349R,35R,351,361,356 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A catheter assembly for peritoneal cavity insertion
comprising
an elongated stylet having a pointed distal end, a proximal end and
a shank extending therebetween; an elongated catheter slidably
disposed around said shank of said stylet; and
gripping means for holding said stylet, said gripping means
including support means secured to said proximal end of said stylet
and handle means of a size to be grasped by a hand, said handle
means extending transversely from said support means and disposed
adjacent said shank of said stylet intermediate and spaced from
said proximal and distal ends whereby said handle means may be
grasped in the palm of one hand with the fingers of the hand
grasping said stylet such that said catheter assembly may be firmly
held in one hand to provide guidance and pressure during peritoneal
cavity insertion.
2. The invention as recited in claim 1 wherein said support means
includes an elongated barrel surrounding said stylet and having a
closed end and an open end, said proximal end of said stylet being
secured in said closed end of said barrel, said shank of said
stylet extending through said open end of said barrel, and said
handle means including a grip member extending transversely from
said barrel at said open end.
3. The invention as recited in claim 2 wherein said barrel has a
bore therein having a diameter slightly larger than the diameter of
said catheter such that said catheter is slidable in said bore,
said bore having an extension of reduced cross section at said
closed end of said barrel, and said catheter having a length
slightly less than the length of said stylet and a first end
disposed at said closed end of said barrel and a second end
disposed at said distal end of said stylet, said second end of said
catheter covering said distal end of said stylet when said first
end of said catheter is adjacent said reduced extension of said
bore and said reduced extension of said bore having a length
sufficient to permit said second end of said catheter to bare said
distal end of said stylet when said first end of said catheter tube
is squeezed further into said reduced extension of said bore.
4. The invention as recited in claim 2 wherein said proximal end of
said stylet is flat and has a width greater than the diameter of
said shank, and said closed end of said barrel has a pair of slots
therein, said flat proximal end being received and anchored in said
slots whereby said stylet is prevented from rotational or
longitudinal movement with respect to said barrel.
5. The invention as recited in claim 4 wherein said barrel has a
bore therein having a diameter slightly larger than the diameter of
said catheter such that said catheter is slidable in said bore,
said bore having an extension of reduced cross section at said
closed end of said barrel, and said catheter has a length slightly
less than the length of said stylet and a first end disposed at
said closed end of said barrel and a second end disposed at said
distal end of said stylet, said second end of said catheter
covering said distal end of said stylet when said catheter is
adjacent said reduced extension portion of said bore and said
reduced extension of said bore having a length sufficient to permit
said second end of said catheter to bare said distal end of said
stylet when said first end of said catheter is squeezed into said
reduced extension of said bore.
6. The invention as recited in claim 5 wherein a flat reinforcing
rib is integrally formed with said barrel and runs along the
longitudinal length of said barrel from said closed end to said
handle grip.
7. The invention as recited in claim 6 wherein said barrel, said
grip member and said reinforcing rib are integrally formed of a
plastic material.
8. The invention as recited in claim 4 wherein said barrel is made
of a plastic material and has first and second blind holes disposed
therein in diametrically opposed relation at said closed end to
define a mass of plastic between each of said slots and each of
said blind holes, respectively, whereby said masses of material may
be melted to anchor said stylet to said barrel.
9. The invention as recited in claim 1 wherein said stylet is bent
upon itself at said proximal end to define said support means and
said stylet, said support means and said handle means are
integrally formed.
10. The invention as recited in claim 1 wherein said support means
includes a support member disposed parallel to said shank of said
stylet, said support member having a first end bent upon itself and
anchored to said proximal end of said stylet and a second end
terminating at an arcuate handle grip defining said handle
means.
11. The invention as recited in claim 1 wherein said support means
extends along said shank of said stylet in parallel relation
therewith.
12. The invention as recited in claim 1 wherein said handle means
is spaced substantially four inches from said distal end of said
stylet.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to surgical instruments and, more
particularly, to a catheter assembly for peritoneal cavity
insertion.
2. Background of the Invention
With its surface area of approximately 22,000 square centimeters,
the human peritoneum is an excellent dialyzing membrane for
removing excessive body wastes, excessive body fluid, excessive
serum electrolytes, and toxic ingestions. This is not surprising,
since the peritoneal surface is approximately equal to the area
available for tubular filtration in the kidneys. Clinical studies
by many investigators have led to refinements in the dialyzing
solution commonly employed, the substances which may be added on
occasion, the equipment for instilling and removing the solution,
and the schedule of dialysis.
The essential steps of the basic procedure involved in peritoneal
dialysis are catheterization, instillation, dialysis, and drainage.
Catheterization for peritoneal dialysis requires insertion of a
catheter into the peritoneal cavity with its tip in the area of the
pelvic gutter. Generally, this is a simple matter of paracentesis
and is performed with an ordinary paracentesis set, using a trocar
and cannula, often as a bedside procedure. Surgical insertion of
the catheter with the use of a trocar and cannula is preferred by
some physicians. Strict aseptic technique should be utilized
throughout the procedure. The midline is usually chosen as the site
for insertion of the trocar and cannula.
After sterile preparation of the desired site, the abdominal
puncture is made and the trocar is removed. A hollow metal cannula
is then advanced to its full length so that only the proximal hub
protrudes. (In very thin individuals, insertion of the set is often
facilitated by prior instillation of two liters of solution to
distend the abdomen. This can be accomplished with a large-bore
needle No. 15 to 18. )
The catheter is then threaded through the cannula and the catheter
maneuvered into position, angling the cannula if necessary. The
catheter must be aimed so that the rounded tip lies in the pelvic
gutter. Gentle maneuvering will push aside omentum and establish a
natural path. (This should be done regardless of the insertion
technique used.) When the catheter is in place, the cannula is
removed.
Next, 2 liters of peritoneal dialysis solution are attached to the
administration set, primed with dialysis fluid, and the catheter
attached to the administration set. Occasionally, incomplete
insertion can be corrected by instilling one or two liters of
solution and then readjusting the catheter. The area of insertion
of the catheter is covered with sterile dressing until the end of
the procedure.
Insertion of the catheter without the use of the trocar and cannula
is preferred by most physicians. The device consists of a 10- 12
inch long 11 Fr. plastic catheter with a metal stylet fitted
inside. The pointed end of the stylet protruding out of the end of
the catheter facilitates insertion into the peritoneal cavity. The
small diameter of the cannula and stylet will result in a catheter
that is significantly flexible and in which the insertion is
difficult to control due to the length and flexibility of the
catheter assembly. Several of the present devices on the market are
provided with a ring at the rear of the stylet to serve as a
pressure point to assist in inserting the catheter assembly.
However, the ring at the rear of the stylet requires application of
pressure up to 12 inches away from the point of insertion; and,
with this long slender flexible catheter assembly, the precise
control required is lacking unless the other hand of the user is
used to control the tip of the catheter. To avoid this impractical
aspect of catheter assemblies presently available, some users of
such devices clamp the catheter and stylet together at the rear to
prevent the stylet point from retracting inside the cannula and
then make their insertion holding the catheter near its tip. This
again, however, is a highly inconvenient and annoying feature and
is one of the primary drawbacks of prior art devices.
SUMMARY OF THE INVENTION
Accordingly, it is an object of the present invention to construct
a catheter assembly which may be manipulated with one hand during
peritoneal insertion while both applying pressure to and guiding
the catheter assembly.
The present invention is generally summarized in a catheter
assembly for peritoneal insertion including an elongated stylet, an
elongated catheter slidably disposed around the stylet, and a
gripping member having a support secured to the proximal end of the
stylet and a handle extending transversely from the support and
disposed adjacent the shank of the stylet whereby the handle may be
grasped in the palm of one hand with the fingers of the hand
grasping the stylet to provide guidance and pressure with one hand
during peritoneal insertion.
Another object of the present invention is to construct a catheter
assembly having a catheter of convenient length and a handle
sufficiently close to the point of the stylet that the point of the
stylet may be guided during insertion by the thumb and forefinger
of the hand gripping the handle.
A further object of the present invention is to provide a catheter
assembly wherein a stylet has a proximal end secured to a support
member extending along a shank of the stylet and a handle extending
from the support member at a position near the distal end of the
stylet to permit insertion with one hand.
The present invention has another object in that a barrel for
supporting a stylet has restrictions therein for maintaining a
catheter in a first position sheathing the pointed distal end of
the stylet and in a second position baring the pointed distal end
of the stylet for insertion.
Some of the advantages of the present invention over the prior art
are that the catheter assembly is economically formed, that
peritoneal insertions can be precisely made, that only one hand is
required to provide both guidance and pressure to the catheter
assembly during insertion, and that aseptic technique is easily
maintained.
Other objects and advantages of the present invention will become
apparant from the following description of the preferred
embodiments taken in conjunction with the drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is an exploded elevation, partially in section, of a
catheter assembly according to the present invention.
FIG. 2 is an enlarged view, partially in section, of the closed end
of the catheter assembly of FIG. 1.
FIG. 3 is a cross-section taken along line 3--3 of FIG. 1.
FIG. 4 is a cross-section taken along line 4--4 of FIG. 1.
FIG. 5 is a cross-section taken along line 5--5 of FIG. 1 with the
catheter and stylet in position.
FIG. 6 is an elevation of another embodiment of the present
invention.
FIG. 7 is an elevation of a further embodiment of the present
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
A catheter assembly in accordance with the present invention is
illustrated in exploded view in FIG. 1 and includes an elongated,
stainless steel, piercing stylet 10, an elongated, flexible plastic
catheter 12 adapted to be slidably disposed around stylet 10 and a
gripping member 14 adapted to receive stylet 10 and catheter
12.
Stylet 10 has a pointed distal end 16 and a flattened proximal end
18 with a cylindrical shank 20 extending therebetween. Proximal end
18 is flattened such that it is wider than the diameter of shank 20
in order to facilitate anchoring thereof in gripping member 14 as
will be explained hereinafter. Catheter 12 is a hollow, cylindrical
tube and has an inner diameter to accommodate stylet 10, as is
illustrated in FIG. 5; and, a rounded or tapered distal end 22 of
catheter 12 is adapted to be disposed adjacent distal end 16 of
stylet 10 while a proximal end 24 of catheter 12 is adapted to be
disposed adjacent proximal end 18 of stylet 10. Four rows of 25
0.020 inch diameter holes 23 are disposed in catheter 12 such that
the total of one hundred holes 23 may be utilized for rapid
diffusion and recovery of the dialysis fluid.
Gripping member 14 includes an elongated barrel 26 having a bore 28
therein extending from an open end 30 to a closed end 32. Bore 28
has a diameter sufficient to permit catheter 12 to slide easily
therein over stylet 10, and a pair of diametrically opposed
restrictions 34 and 35 constrict bore 28 at an extension 36 near
closed end 32 of barrel 26, as is best illustrated in FIG. 4. An
end bore 38 communicates with extension 36 defining a stop 37
therebetween and has a diameter to snugly receive shank 20 of
stylet 10. A pair of diametrically opposed slots 40 and 42 are
longitudinally disposed along end bore 38; the width of slots 40
and 42 being such as to snugly receive flattened proximal end 18 of
stylet 10. A pair of diametrically opposed blind holes 44 and 46
are positioned in barrel 26 adjacent closed end 32 in alignment
with slots 40 and 42, respectively, as is best illustrated in FIG.
3.
Gripping member 14 is preferably molded of an appropriate plastic
material to integrally include a handle grip 48 extending
transversely from barrel 26 adjacent open end 30 and an inverted
T-shaped strengthening rib 50 which extends longitudinally along
the bottom of barrel 26, looking at FIG. 1. Rib 50 terminates at
closed end 32 in tapered fashion and is incorporated in handle grip
48 as a flange extending around the periphery thereof.
In assembly, stylet 10 is secured or anchored in gripping member 14
by sliding the stylet into bore 28 in barrel 26 such that the end
of shank 20 is inserted in end bore 38 and the flattened portion of
proximal end 18 is inserted in slots 40 and 42. With the stylet 10
so inserted in barrel 26, hot staking pins are pushed into blind
holes 44 and 46 to melt the plastic material and force a mass of
the plastic material on either side of barrel 26 into slots 40 and
42 to anchor the proximal end 18 with the gripping member. After
stylet 10 is secured in the gripping member, catheter 12 is slid
into bore 28 around stylet 10 until proximal end 24 of catheter 12
is moved slightly into extension 36 beyond restrictions 34 and 35.
The length of catheter 12 will be such that when end 24 of the
stylet is so positioned, distal end 22 sheathes the pointed distal
end 16 of stylet 10. Catheter 12 is held in place by the deforming
of the proximal end 24 in extension 36 which has a cross section
shape such as to compress catheter 12 against stylet 10; and, with
the catheter assembly as above described, the assembly will
normally be placed in a sterile package.
When it is desired to utilize the catheter assembly, it is removed
from the sterile package, and the catheter 12 is pushed further
into barrel 26 such that proximal end 24 abuts stop 37. The length
of extension 36 is such that with catheter 12 fully inserted in
barrel 26 to abut stop 37, distal end 22 will be positioned on
shank 20 adjacent distal end 16 of the stylet 10 to bare the
pointed distal end for piercing.
The user of the catheter assembly grips handle 48 with the palm of
one hand and, with the forefinger and thumb of the hand, grasps the
rounded distal end 22 of the catheter such that pointed distal end
16 of stylet 10 may be securely held and placed at the point of
insertion with one hand. Pressure may thus be applied to the
catheter assembly via handle 48 while simultaneously controlling
the point of insertion with the thumb and forefinger of the same
hand, and it will be appreciated that accurate insertion of the
catheter through the peritoneum of the patient may be accomplished
with one hand.
After proper insertion of the catheter, the user holds the catheter
12 with one hand while moving gripping member 14 away from the
point of insertion such that gripping member 14 and stylet 10 are
removed while catheter 12 is advanced into the area of the pelvic
gutter. Thus, a convenient length of catheter 12 is available for
administration.
Another embodiment of a catheter assembly according to the present
invention is illustrated in FIG. 6, and parts of the embodiment of
FIG. 6 identical to parts of the embodiment of FIGS. 1-5 are given
identical reference numbers and not described again. Parts of the
embodiment in FIG. 6 which are similar to parts of the embodiment
of FIGS. 1-5 are given reference numbers with "100" added.
In the embodiment of FIG. 6, a gripping member 114 is formed as an
extension of, and integrally with, stylet 10. That is, the shank of
stylet 10 which slidably receives catheter 12 is bent at an acute
angle at proximal end 18 to form a support member 100 extending
along the shank toward the distal end 16. An arcuate handle grip
148 is formed from the end of support member 100 to extend
generally in a direction transverse thereto.
The catheter assembly of FIG. 6 is utilized in a manner similar to
that described with respect to the catheter assembly of FIGS. 1-5
in that handle grip 148 is grasped with the palm of one hand and
the thumb and forefinger are utilized to grip catheter 12 near
distal end 22 in order to permit guidance and pressure on the
catheter assembly with one hand during peritoneal insertion.
A further embodiment of a catheter assembly according to the
present invention is illustrated in FIG. 7, and parts of the
embodiment of FIG. 7 identical to parts of the embodiment of FIGS.
1-5 are given identical reference numbers and not described again.
Parts of the embodiment in FIG. 7 which are similar to parts of the
embodiment of FIGS. 1-5 are given reference numbers with "200"
added.
The primary difference between the embodiment of FIG. 7 and the
embodiment of FIG. 6 is that a gripping member 214 is formed
separately from stylet 10 rather than integrally therewith. The
upper end 200 of gripping member 214 is bent upon itself and molded
to have slots therein, similar to slots 40 and 42 in the embodiment
of FIGS. 1-5. The flattened proximal end 18 of stylet 10 is
inserted in the slots and anchored to gripping member 214 such as
by the use of hot staking pins. A support member 202 extends from
end 200 along shank 20 of stylet 10 to an arcuate handle grip 248
which extends transversely therefrom. Catheter 12 is slidably
positioned on stylet 10 for insertion therewith.
In use, the catheter assembly of FIG. 7 has the same advantages as
previously described with respect to the embodiments of FIGS. 1-5
and FIG. 6, in that the user may grasp handle grip 248 with the
palm of one hand while squeezing catheter 12 adjacent distal end 22
to grip stylet 10 and properly position and apply pressure to the
catheter assembly with one hand.
In each of the embodiments illustrated in FIGS. 6 and 7, the
proximal end 18 of stylet 10 may be enlarged in order to form a
stop against which the proximal end 24 of catheter 12 can be
positioned to ensure that the rounded distal end 22 will form a
sheath over the pointed distal end 16 of the stylet during shipping
of the catheter assembly.
It will be appreciated that all of the above described catheter
assemblies permit peritoneal cavity insertion of a catheter with
only one hand due to the positioning of a handle grip adjacent the
shank of a stylet such that the stylet can be grasped near its
pointed distal end with the fingers of one hand while the handle
grip is held with the palm of the same hand. Specifically, the
proximal end of the stylet is anchored with a gripping member to
prevent rotational or longitudinal movement therebetween; and in
the embodiment of FIGS. 1-5, the handle grip is supported at the
open end of a barrel through which the shank of the stylet extends
whereas in the embodiments of FIGS. 6 and 7 a support member
extends along the shank of the stylet to support the handle grip at
a position adjacent the shank of the stylet.
The lengths of the stylet, the catheter and the gripping member may
be varied dependent upon the desired use of the catheter assembly;
however, the catheter will normally have a length of from ten to
twelve inches for peritoneal insertion. The stylet will, of course,
be slightly longer than the catheter to permit the pointed distal
end of the stylet to extend beyond the distal end of the catheter,
and the gripping member will have a length such that the handle
grip is spaced approximately 4 inches from the pointed distal end
of the stylet.
Inasmuch as the present invention is subject to many variations,
modifications and changes in detail, it is intended that all matter
described in the foregoing specification or shown in the
accompanying drawings shall be interpreted as illustrative and not
in a limiting sense.
* * * * *