U.S. patent number 3,654,932 [Application Number 04/880,178] was granted by the patent office on 1972-04-11 for surgical drain for shunting fluid.
Invention is credited to Wolff M. Kirsch, John B. Newkirk, Paul K. Predecki.
United States Patent |
3,654,932 |
Newkirk , et al. |
April 11, 1972 |
SURGICAL DRAIN FOR SHUNTING FLUID
Abstract
Hydrocephalus shunt which includes a subcutaneous pump, devoid
of rigid or metallic parts, characterized by a one-way slit valve
which may be distorted and opened by digital pressure in the plane
of the slit to break up and dislodge any particulate matter which
may be clogging the valve. The body of the pump includes means for
positioning said pump, following subcutaneously implanting thereof,
within the body tissue such that the slit is maintained in a
position generally normal to the surface of the cranium. Said means
of said pump may include projections which may be sewed to soft
tissue beneath the scalp or may include a pump of predetermined
cross section such as of oval cross-sectional configuration.
Inventors: |
Newkirk; John B. (Englewood,
CO), Predecki; Paul K. (Denver, CO), Kirsch; Wolff M.
(Denver, CO) |
Family
ID: |
25375656 |
Appl.
No.: |
04/880,178 |
Filed: |
November 26, 1969 |
Current U.S.
Class: |
604/9; 604/185;
604/247 |
Current CPC
Class: |
A61M
25/02 (20130101); A61M 27/006 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61M 27/00 (20060101); A61m
027/00 () |
Field of
Search: |
;128/350,35V,274
;251/342 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
What is claimed is:
1. A surgical drain for shunting fluid from a body cavity, said
drain being adapted to be subcutaneously implanted, said drain
comprising:
a. an inlet conduit adapted to have a first end thereof disposed
within a body cavity;
b. an outlet conduit adapted to have a first end thereof positioned
outside of said body cavity for discharge of fluid, said first end
having a normally closed, one-way slit valve formed therein and
adapted to be opened by a differential pressure between the body
cavity and the position of discharge of the fluid; and
c. an elongate, generally cylindrically shaped, pump tube
constructed from a resilient, nonmetallic material, such as
silicone rubber, and interconnecting said inlet and outlet
conduits, said pump tube including means for determining the
clogging up of said surgical drain at any one of three separate
points, said means including:
1. an inlet into said pump tube, said inlet comprising an end wall
integrally formed with said pump tube, said end wall having a slit
formed therein to form a one-way slit valve, said slit adapted to
be opened by digital pressure applied thereto in a direction
substantially in the plane of a slit and radially outwardly from
the slit without creating undesirable back pressure in the inlet
conduit, thereby enabling the determination whether said slit valve
has become clogged up,
2. a single pump chamber disposed downstream from the slit valve of
said pump tube, taken with respect to the direction of fluid flow
from the inlet of the pump tube to the outlet conduit, (i) said
pump chamber being of sufficient length that, upon actuation
thereof by application of digital pressure thereto, fluid is caused
to flow only through the outlet conduit and the slit valve formed
in the outlet conduit without opening of otherwise affecting the
operation of the slit valve or the pump tube thereby enabling the
determination whether clogging up of said outlet conduit or its
slit valve exists, (ii) said pump chamber, upon actuation thereof
by application of digital pressure thereto and simultaneous opening
of the pump tube slit valve by application of digital pressure
thereto in the plane of the slit thereof, causing fluid to flow in
opposite directions, thereby enabling the determination whether
clogging up of said inlet conduit exists where it has previously
been determined that neither the pump tube inlet slit valve nor the
outlet conduit and its slit valve is clogged up, and
3. means for affixing and maintaining said pump tube, following
subcutaneously implanting thereof, within body tissue such that the
slit in the pump tube slit valve is disposed in a predetermined
position substantially normal to the skin whereby digital pressure
applied to said slit valve will distort said end wall and open the
slit without rotating said slit out of its said predetermined
position normal to the skin, whereby said means enables the opening
of said pump tube slit valve with the application of minimum
digital pressure.
2. A drain in accordance with claim 1 wherein the means for
affixing the pump tube to body tissue comprises a pair of opposed
projecting flat wings integrally formed thereon.
3. A drain in accordance with claim 2 wherein the drain tube is
provided with a closed end and the outlet valve comprises a pair of
diametrically disposed longitudinally extended slits through its
wall.
4. In a surgical drain for shunting fluid from a body cavity, such
as ventricle cavity, and of the type adapted to be subcutaneously
implanted and including a flexible pump tube which may be
compressed by digital pressure applied to the skin, the pump having
a one-way slit valve, the drain also having a one-way outlet valve,
the valves being normally closed and adapted to be opened by the
differential pressure between the cavity and the position of
discharge of the fluid, the improvements in combination
comprising:
a. said slit valve being disposed within the pump tube adjacent one
end thereof and having an end wall with a transversely extending
normally closed slit therein,
b. the pump tube and end wall being integrally formed of resilient
non-metallic material, such as silicone rubber,
c. the slit adapted to be opened by digital pressure applied to the
pump tube in a direction substantially in the plane of the slit and
at a position on the pump tube adjacent and radially outward from
the slit,
d. said pump tube including means for positioning said tube,
following subcutaneously implanting thereof, within body tissue
such that the slit is disposed substantially normal to the skin,
whereby digital pressure applied to same may distort said end wall
and open the slit, and
e. the drain tube is formed of at least two telescoping sealed
portions having different diameters for permitting it to be
lengthened to accomodate body growth, the portion having the larger
diameter including an annular, radially inwardly extending rib
formed on the inner surface thereof, the portion having the smaller
diameter including one or more annular radially outwardly extending
ribs formed on the outer surface thereof, each rib of one of said
portions being disposed in sealing engagement with the adjacent
surface of the other said portion, and the rib of one portion
cooperating with an adjacent rib of the other portion to resist
longitudinal separation of one portion from the other.
Description
BACKGROUND OF THE INVENTION
In the treatment of hydrocephalus it is common practice to provide
a drain tube, containing one or more valves, also known as a shunt,
between the source of cerebrospinal fluid within a ventricular
cavity of the patient and the vascular system, such as the jugular
vein. It is generally recognized that the shunt should be provided
with at least one check or one-way valve which may open due to the
slight differential pressure between the inlet or proximal end of
the shunt and its outlet or distal end, and close in event the
pressure differential reverses, which may occur by coughing or
straining of the patient, thereby to prevent a reverse flow of
blood or other fluid through same. The patent to Heyer U.S. Pat.
No. 3,020,913 is exemplary of a single valve shunt of the type
referred to. Since this type of shunt is implanted in the patient
it will be apparent that there is no external control over the
valve in the event it becomes clogged with particulate matter. The
patent to Holter et al., U.S. Pat. No. 2,969,066, is exemplary of
another type of shunt which includes a pump, also implanted beneath
the skin, which may be manually operated by digital pressure, the
pump comprising a resilient compressible rubber tube. With this
type of pump two check valves are required, these being normally
closed valves but adapted to open in normal operation by the higher
pressure which exists in the ventricular cavity. If it is desired
to pump fluid through the Holter-type shunt by digital manipulation
the pump tube is compressed which increases the pressure within
same and opens the outlet or distal valve. Upon release of pressure
on the pump tube the distal valve closes and the resilient recovery
of the tube to its normal volume creates a reduced pressure in same
which normally opens the inlet or proximal valve and permits fluid
to enter through same. However, in the event the proximal valve is
clogged by particulate matter and does not open by the differential
pumping pressure, the shunt then becomes inoperative and surgical
replacement may become necessary.
The patent to Schwartz U.S. Pat. No. 3,109,429 is similar to the
Holter device, employing a compressible pump tube but differs
principally in that the check valves are normally open rather than
normally closed. This patent discusses disadvantages of the Holter
shunt and also briefly outlines the history of such devices, the
problems involved, and certain desiderata which should be met.
SUMMARY OF THE INVENTION
The present invention is probably most closely related to the
Holter device in that it employs a subcutaneous pump tube with a
normally closed inlet slit valve which, in one mode of operation,
may open by pump pressure in the same manner as in the Holter
device. The inlet valve, however, differs in that it may also be
manually opened by digital pressure in the event that it is clogged
and will not open by fluid pumping pressure. Manual manipulative
control over the inlet valve thus renders it possible to flush the
ventricular apertures in the shunt, the proximal slit valve, and a
distal slit valve, thus removing any clogging matter disposed in
any part of the shunt. Since the inlet slit valve can be
effectively opened only by pressure in the plane of the slit,
suitable means such as projections are formed on the valve body to
permit it to be sewn to soft tissue beneath the scalp in a position
such that the slit is disposed normal to the cranium and remains in
such position against any tendency to rotate or migrate from the
desired position. More specifically, the projections are in the
form of a pair of flat extending wings, the plane of which lies
parallel with the skull and normal to the proximal slit direction.
A further feature is that the valve body and its slit valve are
integrally molded from silicone rubber and no metal or rigid parts
are employed in the shunt. The principal objectives of the
invention are thus to provide a shunt pump having a slit check
valve which may be manually distorted and opened by digital
pressure in contradistinction to only fluid differential pressure,
and suitable means on the pump for implanting it in a position such
that the slit valve is disposed normal to the skull. Another
objective is to provide a shunt pump which reduces the possibility
of patient injury in the event of a blow to the head. Another
objective is to eliminate all metallic parts which might induce
tissue reaction or blood coagulation. A further objective is to
provide a shunt which is extremely simple in construction and so
economical to manufacture that it may be made available to those of
limited means. Still further objectives, advantages, and salient
features will become more apparent from the description to follow,
the appended claims, and the accompanying drawing.
BRIEF DESCRIPTION OF THE DRAWING
FIG. 1 is an isometric view of a pump showing the proximal
valve;
FIG. 2 is a longitudinal central section through the pump of FIG.
1, illustrating its intermediate position between inlet and outlet
drain tubes;
FIG. 3 illustrates a position of implantation of the invention;
FIG. 4 illustrates one mode of operation of the pump;
FIG. 4a is a section taken on line 4a--4a, FIG. 1, illustrating the
slit valve when the pump is operated in the mode of FIG. 4;
FIG. 5 illustrates another mode of operation of the pump;
FIG. 5a is a section taken on line 5a--5a, FIG. 1, illustrating the
slit valve when the pump is operated in the mode of FIG. 5; and
FIG. 6 is a longitudinal section through an alternative form of
pump outlet drain tube.
DESCRIPTION OF PREFERRED EMBODIMENT
Referring now to the drawing, and first to FIGS. 1 to 3, the
subject of the invention comprises, in general, a resilient pump
tube 10 interposed between an inlet tube 12 and an outlet tube 14,
a suitable catheter 16, having apertures 18 near its end, being
connected directly or with intermediate devices, to tube 12, the
construction as so far described being conventional and surgically
implanted in a patient as in the Holter device previously referred
to and also as illustrated in FIG. 3.
Pump tube 10 is provided with a tubular projection 20 extending
into one end of same and spaced from the inner wall of tube 10
which is provided with a conical or dome shaped end wall 22 having
a slit 24 in same which is closed except when fluid is draining in
the direction of arrow 26, FIG. 2. A pair of flat diametrically
opposed and radially extending wings 28 are disposed adjacent the
other end of tube 10 which may be sewed to soft tissue with the
wings lying parallel with the skull and the slit perpendicular to
the skull. Tube 14 is provided with a tapered closed end 30 to aid
in implanting into a blood vessel and a pair of diametrically
opposed longitudinally extending slit valves 32 are provided
adjacent its closed end which are also normally closed but may open
when fluid is flowing into the blood vessel or other position of
discharge of the fluid. While these slits in part determine the
flow rate of fluid through the entire shunt, they may be lengthened
by a scalpel to increase their calibrated flow rate at the
discretion of the surgeon prior to implantation.
During normal operation subsequent to implantation, fluid flows
through apertures 18 in catheter 16, thence through tube 12, slit
valve 20, pump tube 10, outlet tube 14 and slit valves 32. Since
the pressure in the ventricular cavity slightly exceeds the
pressure at the position of discharge, fluid will readily and
naturally flow from the ventricular cavity to the position of
discharge. In the event that the pump tube slit valve 24 or the
discharge slit valves 32 should become clogged with particulate
matter at some future time, it then becomes necessary to open same
by manual application of digital pressure on the skin to compress
the pump tube which is, in effect, a variable chamber device, the
volume of which may be reduced by flattening from a normally
circular section to a somewhat elliptical section. FIG. 4
illustrates application of digital pressure at a point remote from
slit valve 24 in which the pumping action would be like that in the
Holter device, that is, if slit valve 24 is clogged it could be
made to open by the differential pressure, upon release of digital
pressure, when the tube resiliently returns to its normal circular
cross section. This mode of operation, however, is intended
principally for opening clogged slit valves 32 to produce flow in
the direction of the arrow, FIG. 4. In the other mode of operation
the pump tube is compressed at a point adjacent slit valve 24 as
illustrated in FIG. 5. This distorts projection 20, flattening it
in the plane of the slit and opening it as shown in FIG. 5a. In
this mode of operation flow may take place in the directions of the
two arrows, FIG. 5, also back flushing any matter clogging
apertures 18, which flow conditions, so far as known, were not
possible to attain in pump-type shunts of the prior art by
manipulation of the shunt through application of pressure through
the skin. As will now become apparent, the invention provides means
for (a) forward flushing of a normally closed and clogged one-way
discharge valve (b) for manually opening a normally closed and
clogged one-way inlet valve, and (c) for back flushing clogged
inlet apertures in the catheter communicating with fluid in the
ventricular cavity, thus enabling the opening of the various
apertures and valves without resort to surgical replacement of the
shunt in event of malfunction. Pump tube 10, wings 12 and
projection 20 are integrally molded from flexible material such as
Silastic, a trade name of Dow Corning Corporation of Midland, Mich.
for a silicone rubber, after which slit 24 is cut. Tubes 12 and 14
are then attached within apertures in the ends of the pump tube by
suitable medical grade Silastic rubber adhesive.
FIG. 6 illustrates an alternative form of outlet tube comprising
telescopic portions 14a, 14b, sealed by annular projections 34.
With this construction the outlet tube may be lengthened with body
growth, since the tubes can be extended by sliding one with respect
to the other under the skin by careful manipulation of the tubes.
This operation can be performed externally without the need for
surgery.
The means 28 for affixing the pump tube in a predetermined position
to prevent rotation or other migration of same may be of a form
other than radially extending wings, such as any non-circular form
which will serve the same function.
In view of all the foregoing, it will now be readily appreciated
that an improved hydrocephalus shunt has been described. This
shunt, which is installed beneath the surface of the skin, may be
suitably manipulated through the skin to remove any clogging matter
which may become disposed in any part of the shunt even though
there is no direct access to the shunt itself without surgery.
Further, the shunt includes means for resisting any tendancy of the
shunt to rotate or migrate from a desired position. Finally, the
shunt is formed without incorporating therein any metal or rigid
parts.
It is to be understood that this invention is not limited to the
exact embodiment shown and described, which is merely by way of
illustration and not limitation, as various other methods will be
apparent to those skilled in the art. For example, the pump tube 10
may be formed to have a predetermined cross-sectional
configuration, such as an oval-shaped cross-sectional
configuration, which, following subcutaneously implanting thereof,
cooperates with the body tissue to maintain the slit in a position
normal to the surface of the cranium. An oval-shaped configuration
similar to that of the tube 10 as shown in FIG. 5a is contemplated
although the ratio of the minor axis to the major axis would be
less than that shown.
* * * * *