U.S. patent number 3,894,541 [Application Number 05/446,420] was granted by the patent office on 1975-07-15 for method of treating hydrocephalus.
Invention is credited to Ismail Lotfy El-Shafei.
United States Patent |
3,894,541 |
El-Shafei |
July 15, 1975 |
Method of treating hydrocephalus
Abstract
This disclosure relates to a catheter and method for its use to
establish a connection between the cerebral ventricles and the
proximal segment of a ligated neck vein for treating hydrocephalus.
This method for shunting the cerebrospinal fluid (CSF) to the
venous circulation prevents blood from coming into contact with the
shunt tube and prevents a syphonage force from developing when the
patient assumes the upright position. The catheter consists of a
tubing of soft tissue-compatible material and is provided with a
simple check valve to prevent reflux of blood. It has a side tube
and it is also provided with means for: 1) easy insertion into the
ventricle; 2) protection of the intake apertures; 3) watertight
closure of the dura mater around it; 4) resistance to kinking; 5)
provision of an available extra length of 5 cms; and 6) resistance
to being pulled out of the neck vein due to movements of the head
and neck.
Inventors: |
El-Shafei; Ismail Lotfy
(Zamalik, Cairo, ET) |
Family
ID: |
23772508 |
Appl.
No.: |
05/446,420 |
Filed: |
February 27, 1974 |
Current U.S.
Class: |
604/10 |
Current CPC
Class: |
A61M
25/007 (20130101); A61M 1/84 (20210501); A61M
27/006 (20130101); A61M 25/09025 (20130101); A61M
25/0068 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 27/00 (20060101); A61M
1/00 (20060101); A61m 027/00 () |
Field of
Search: |
;128/348,35R,35V |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Wigman & Cohen
Claims
I claim:
1. A method of treating hydrocephalus comprising the steps of
establishing a connection between the lateral ventricle and a
ligated neck vein using a catheter having a ventricular end and a
venous end, eliminating the syphonage force which develops with
conventional valve systems when the patient assumes the upright
position, and preventing contact between the shunting catheter and
the circulating blood by inserting the venous end of the catheter
into the proximal segment of the ligated neck vein against the
direction of blood flow.
Description
This invention relates generally to the surgical arts, and more
particularly to a method and apparatus for treating hydrocephalus
by establishing a ventricle venous shunt between the lateral
ventricle and the proximal portion of a ligated neck vein.
BACKGROUND OF INVENTION
At the present time, there are several valve systems to provide
ventriculo-atrial shunts to drain CSF from the ventricles of the
brain into the venous blood stream. Examples of these systems are:
U.S. Pat. No. 2,969,066 (Holter et al,); U.S. Pat. No. 3,020,913
(Hyer-Pudenz); and U.S. Pat. No. 3,288,142 (Hakim).
In treating hydrocephalus using one of these valve systems a
catheter is thrust into the ventricles of the brain in order to
drain unwanted fluid therefrom, and is then led through the jugular
vein into the heart so that the fluid from the ventricles enters
the blood stream and is disposed of by the process of purification
of the blood.
Two main disadvantages encountered with conventional shunt systems
are:
1. THE DEVELOPMENT OF A SYPHONAGE FORCE WHENEVER THE PATIENT
ASSUMES THE UPRIGHT POSITION. This force corresponds to the height
of the CSF column in the shunting catheter and eventually causes
excessive ventricular drainage which may lead to the development of
intracranial haemorrhage and/or collapse of the cerebral ventricles
increasing the chances of blockage of the ventricular end of the
shunting catheter;
2. THE SHUNTING CATHETER WHICH LIES DIRECTLY IN THE BLOOD STREAM
ACTS AS A FOREIGN BODY AND MAY EXCITE BLOOD CLOTTING, VENOUS
THROMBOSIS AND EMBOLIC COMPLICATIONS.
Therefore, as disclosed in co-pending application Ser. No. 316,995,
the purpose of the shunt system and the catheter of this invention
is in general to avoid all the above difficulties and complications
by providing means for treating hydrocephalus by using the catheter
of this invention to establish a connection between the cerebral
ventricles and the proximal segment of a ligated neck vein, e.g.,
the external jugular vein (EJV) or the common facial vein
(CFV).
In the aforementioned co-pending application Ser. No. 316,995 it is
disclosed that the reason for the reflux of blood into the venous
end of a non-valved shunting tube is the fact that there is a
reduction in the suction effect exerted on the CSF caused by the
running blood in the veins during periods of high intrathoracic
pressure, as compared with the suction effect during periods of
normal intrathoracic pressure. Accordingly, a catheter and method
for its use was disclosed which could be inserted into the vein in
such a way as to prevent the suction effect of the running blood
from exerting its effect on the CSF so that the blood would not
regurgitate into the tube during periods of high intrathoracic
pressure. This method of establishing the ventricle venous
connection commprised inserting the ventricle end of the catheter
into the lateral ventricle such that no CSF could leak from the
dural hole made for the tube insertion into the ventricle, and the
open venous end of the tube was to be inserted into the proximal
segment of a ligated neck vein against the direction of blood flow.
The catheter disclosed in the instant application represents an
improvement over the catheter as disclosed in the aforementioned
co-pending application. Moreover, the instant application includes
further details and elaboration of the method disclosed in the
aforementioned co-pending application.
Accordingly, it is a primary object of this invention to provide a
method for establishing a ventriculo venous (VV) connection to the
proximal segment of a ligated neck vein which will avoid most of
the difficulties and complications encountered in treating
hydrocephalus by the conventional ventriculo-atrial drainage
systems.
More particularly, it is an object of this invention to provide a
catheter which will facilitate establishing the aforementioned VV
connection.
Another object of this invention is to provide a catheter made of
tissue-compatible material having means for easy insertion into the
cerebral ventricle through a small dural hole.
Another object of this invention is to provide a catheter as
abovedescribed having means for protection of the drainage
apertures in the wall of the catheter tubing at its ventricular
end.
Still another object of this invention is to provide a catheter
having means which will facilitate a watertight closure of the dura
mater around the catheter.
Yet another object of this invention is to provide a catheter as
above described having means for introducing a stylet therein to
provide an axial force for inserting the catheter into the
ventricle.
A further object of this invention is to provide a catheter as
above-described having means for recording pressures in the
ventricles and in the venous side of the VV connection.
Still another object of this invention is to provide a catheter as
above-described having means for monitoring the patency of the
shunt system provided by the VV connection.
Another object of this invention is to provide a catheter as
abovedescribed having means for prevention of reflux of blood
therein.
Another object of this invention is to provide a catheter as
above-described having the provision of an available extra 5 cms to
the length of the catheter which will accommodate variations in the
length of body segment bridged by the catheter.
A further object of this invention is to provide a catheter as
above-described having resistance to kinking at the sites of curves
in the course of the catheter as well as resistance to being pulled
out of the vein due to movements of the head and neck.
With the above and other objects in view that may hereinafter
become apparent, the nature of the invention may be more clearly
understood by reference to the several views illustrated in the
accompanying drawings, the following detailed description thereof,
and the appended claimed subject matter:
IN THE DRAWINGS
FIG. 1 is a schematic illustration of the head and neck of an
individual, and illustrates the ventriculo venous shunt (VV) of
this invention showing the catheter in its place to establish the
connection between the cerebral ventricle and the proximal segment
of a ligated EJV;
FIG. 2 is a plan view of the catheter of this invention, having
portions thereof cut away for clarity to illustrate internal
portions thereof;
FIG. 3 is a plan view of a stylet which may be utilized to insert
the catheter illustrated in FIG. 2.
Referring now to the drawings in detail, there is illustrated in
FIG. 2 a catheter made of soft silicone rubber or any other
tissue-compatible material and has a simple, unidirectional check
valve (V) incorporated near its middle. For purposes of
description, the catheter can be divided into a ventricular segment
and a venous segment between which the check valve (V) is
incorporated. The ventricular segment extends from the ventricular
tip to the check valve and comprises the following: (1) a
ventricular tip (A) which is firm blind pointed with a depression
(D) on its inside for lodging a stylet (S), FIG. 3, which is used
to provide an axial force for inserting the catheter into the
ventricle. This arrangement keeps the pointed tip pointing forwards
and permits its easy insertion through a tiny dural hole; (2)
intake apertures (H) in the wall of the first two centimeters of
the ventricular end of the catheter which permit the flow of CSF
from the ventricle into the catheter; (3) soft silicone rubber
flanges (F1) attached to the catheter wall and projecting between
the apertures (H) protect them by bending and closing them during
insertion of the catheter into the ventricle and reopen inside the
ventricle thereby keeping the apertures away from the wall of the
ventricle and from the choroid plexus; (4) a single soft silicone
rubber flange (F2) is attached to the catheter at a distance
approximately 10 cms from the ventricular tip. The flange (F2)
marks the extent of catheter to be inserted through the dural hole
and is also used for obtaining a watertight closure of the dura
mater around the catheter either by using Histacryl to stick the
flange to the dura mater or by suturing it. This flange (F2) can be
made of a larger diameter than the flanges (F1) protecting the
apertures (H); (5) a few centimeters beyond the flange (F2) a side
tube (T) projects from the main catheter at an angle of about
45.degree.. The side tube is of the same thickness and bore as the
rest of the catheter and measures about 4 cms in length. It is used
as a means for inserting the stylet (S), FIG. 3, into the
ventricular segment of the catheter. It can also be connected to a
manometer to record the pressure in the ventricle or in the vein
side of the connection during the operation. The side tube (T) is
tied after the satisfactory establishment of the VV connection and
can be used later to check the patency of the shunt system if such
a step is ever needed; (6) two strong side flanges (F3) with holes
are attached to the catheter at the point of its junction with the
side tube. The flanges (F3) are used for fixing the catheter to the
periosteum by sutures (FIG. 1, Lig. 3).
The simple check valve (V) which separates the ventricular from the
venous segment of the catheter lies a few centimeters beyond the
side tube (T). This valve prevents reflux of blood into the
catheter but it has nothing to do with the regulation of the
intraventricular pressure (IVP).
The venous segment of the tube extends from the check valve till
the venous end and consists of: (1) the venous end of the catheter
which includes a bulbous portion (G) so as to prevent its slipping
out from the neck vein due to movements of the neck. The outside
diameter of the bulbous venous end (G) of the catheter is
approximately double that of the main portion of the catheter and
therefore it is unlikely to slip out from the vein when a ligature
is tied around the vein to hold the tube inside it; (2) a
kink-proof segment which extends from the bulbous venous end for a
distance of about 15 cms. A spiral wire (Sp.W) is incorporated into
the venous portion of the catheter to prevent kinking and occlusion
of the catheter at the point where it curves up to enter into the
tied neck vein; (3) the other half of the venous segment has an
expansible telescoping segment (TS) which can provide an extension
of the tube an extra length of about 5 cms. Such a length is needed
to allow for variations in the length of body segment bridged by
the shunting catheter as occurs during movements of the head or due
to an increase in length of the individual.
Exemplary dimensions of the elements of this invention may be as
follows: Its length may be approximately 37 cms, the outside
diameter of the tubing may be approximately 2.2 mms, the lumen may
be approximately 1 mm. The distance between the ventricular tip and
the flange (F2 in FIG. 2) may be approximately 10 cms, from the
flange (F2) to the side tube (T) may be approximately 3 cms and
from the side tube to the valve (V) may be approximately 3 cms. The
segment of tube between the check valve (V) and the bulbous venous
end (G) of the catheter may be approximately 20 cms. A spiral wire
(Sp.W) or any anti-kinking system is incorporated in the 15 cms of
tubing next to the bulbous venous end (G) while in the remaining 10
cms of tubing between the end of the spiral wire and the check
valve the telescoping segment (TS) is incorporated into the
catheter. Of course, depending on the intended use and the age of
the patient, these dimensions and arrangements can be varied at
will.
The theoretical basis for the suggested ventriculo venous (VV)
connection (FIG. 1) is as follows: If a neck vein, e.g., the EJV,
is tied (Lig. 1 in FIG. 1) above the valve in its lower end, the
pressure in the proximal segment of the vein rises to about +8 to 9
cms saline. If the catheter of this invention (FIG. 2) is used to
establish a connection between the cerebral ventricle and the
proximal segment of the ligated EJV provided that CSF loss or
leakage is not allowed to occur, a closed system will be
established one side of which will be the cerebral ventricles and
the other side will be the vein segment BC in FIG. 1. Since the
pressure in the hydrocephalic ventricles is much higher than the
pressure in the vein segment BC, the CSF will flow from the
cerebral ventricle, through the shunt tube and through the vein
segment BC, washing the blood away from it and converting it into
an extension to the shunt tube. The CSF enters the venous
circulation at point C via the tributaries of the tied vein. The
flow of CSF continues until a state of equilibrium between the
pressures in the cerebral ventricles and in the vein segment BC
takes place, and the CSF will flow thereafter into the venous
circulation at a rate corresponding to the rate of its
formation.
Establishing the VV connection in this way fulfills the following
advantages: (1) the vein segment BC will be converted into an
extension to the shunt tube connecting the venous end of the
catheter (at point B) to the circulating venous blood at point C.
This vein segment will be full of CSF which acts as a barrier
preventing contact between the catheter and the circulating blood;
(2) the higher pressure created in the proximal segment of the tied
vein provides a resistance to the flow of CSF and maintains the
intraventricular pressure (IVP) at a level higher than the pressure
in the vein segment by an amount that will depend on the rate of
CSF formation. The average IVP after establishing the connection is
around +12 cms saline which is within normal limits. This means
that no excessive ventricular decompression takes place; (3) reflux
of blood into the catheter cannot occur because of a simple check
valve (V in FIGS. 1 and 2) incorporated into it. Dissimilar from
other valves used in conventional ventriculo-atrial catheters, the
valve in this invention has nothing to do with the regulation of
the IVP, its only job is to prevent reflux of blood; (4) a
syphonage effect does not occur when the patient assumes the
upright position because of the hydrostatic pressure of the blood
in the veins of the head and neck.
METHODS OF ESTABLISHING THE VV CONNECTION
The ventricular end of the catheter is inserted into the cerebral
ventricle via a small hole in the dura mater which is exposed
through a posterior temporal burr hole. The stylet (S), which is
approximately 25 cms long wire of a thickness less than the bore of
the catheter (approximately 0.5mm), is introduced via the side tube
and passed into the ventricular segment of the catheter to lodge in
the depression (D) on the inside of the ventricular tip (A), and is
used to provide an axial force to insert the catheter into the
ventricle until the soft silicone flange (F2 in FIG. 2) comes into
contact with the dura mater. The flange (F2) is fixed to the dura
mater using Histacryl or sutures (Lig. 3) so as to obtain a
watertight closure of dura mater around the catheter. The side
flanges (F3) at the junction of the side tube with the main
catheter are fixed to the periosteum by sutures. The venous end of
the tube is passed through a tunnel under the skin just posterior
to the mastoid process and emerges in a neck wound made to expose
the EJV or the CFV. The vein chosen for the anastomosis is tied (if
the EJV is used it is tied above the valve in its lower end, if the
EJV is slender the CFV can be used and it is tied at its entrance
into the internal jugular vein). A side opening is made into the
vein wall proximal to the tied ligature and the bulbous venous end
(G) of the catheter is inserted into the vein in an upward
direction for a distance of about 1 cm (FIG. 1) against the
direction of the blood stream. The side opening (SL) in the vein
wall is closed around the catheter using vascular sutures and a
ligature (Lig. 4) is tied around the vein proximal to the bulbous
venous end (G) of the catheter to prevent it slipping out of the
vein. As a further measure against pulling of the catheter out of
the vein during movements of the neck, a stitch (Lig. 5) is taken
to anchor the catheter to the deep facia near the vein opening. The
force of any pull on the catheter will be expended at the anchoring
stitch (Lig. 5) and will not be effective at the catheter vein
junction. Throughout the procedure clamps are applied on the side
tube and on the venous segment of the catheter to prevent CSF loss.
After establishing the connection, the side tube can be connected
to a manometer so as to record the pressure in the cerebral
ventricle or in the vein. The side tube is closed (Lig. 2) and
fixed to the periosteum before closing the skin wounds.
While the invention has been specifically illustrated and described
herein with reference to a preferred embodiment thereof, it is
contemplated that minor modifications could be made therein without
departing from the spirit of the invention.
* * * * *