U.S. patent number 3,583,387 [Application Number 04/785,641] was granted by the patent office on 1971-06-08 for pressure absorbing appliance for treating hydrocephalus.
This patent grant is currently assigned to N/A. Invention is credited to Leo A. Bullara, John T. Garner.
United States Patent |
3,583,387 |
Garner , et al. |
June 8, 1971 |
PRESSURE ABSORBING APPLIANCE FOR TREATING HYDROCEPHALUS
Abstract
An expansible bellows having a variable internal volume is
mounted in a housing adapted for implantation in the skull of a
patient suffering from hydrocephalus. A tube extends from the
bellows for insertion into a ventricle of the brain. When so
installed, the bellows is filled with ventricular fluid at an
average or static pressure. Pulsation of choroid-plexus blood
vessels in the brain tends to cause a periodic increase in fluid
pressure, but bellows expansion in response to increased pressure
minimizes the actual increase in fluid pressure. The resulting
suppression of pulsatile pressure peaks and dissipation of energy
by the bellows appears to be an effective technique for treating
hydrocephalus.
Inventors: |
Garner; John T. (San Marino,
CA), Bullara; Leo A. (Glendora, CA) |
Assignee: |
N/A (N/A)
|
Family
ID: |
25136148 |
Appl.
No.: |
04/785,641 |
Filed: |
December 20, 1968 |
Current U.S.
Class: |
600/561; 604/8;
623/66.1; 128/899; 604/118 |
Current CPC
Class: |
A61M
27/006 (20130101); A61M 25/02 (20130101); A61M
25/007 (20130101); A61M 2025/0213 (20130101); A61M
2025/028 (20130101) |
Current International
Class: |
A61M
25/02 (20060101); A61M 27/00 (20060101); A61M
25/00 (20060101); A61b 019/00 (); A61f
005/00 () |
Field of
Search: |
;128/2,350,35V,1,76,275
;138/26,30 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Claims
We claim:
1. A pressure absorbing appliance for relieving excessive fluid
pressure in a human-body cavity, comprising:
a housing adapted to be secured in the body;
an expansible bellows supported in the housing and having an
internal chamber of variable volume, the chamber having an inlet
opening; and
a tube connected to the bellows in fluid communication with the
chamber inlet opening, and extending from the bellows and housing
for insertion in the cavity;
the bellows being movable within the housing to vary the chamber
volume in response to fluid pressure variations, and the chamber
being closed other than at the inlet opening so fluid therein is
isolated from the housing, the appliance being made of
body-compatible materials suitable for implantation.
2. The appliance defined in claim 1 in which a portion of the
bellows is formed of a self-sealing member through which a
hypodermic needle can be inserted.
3. The appliance defined in claim 2 in which the housing has an
outer end defining an opening in alignment with the self-sealing
bellows portion, and further comprising a second self-sealing
member secured to the outer end of the housing across the
opening.
4. The appliance defined in claim 3 in which the housing is
generally cylindrical and in which the outer end of the housing
includes an attachment flange extending radially outwardly
therefrom, the attachment flange having ligature holes formed
therethrough.
5. The appliance defined in claim 4 in which the bellows has an end
wall remote from the outer end of the housing, the end wall having
a portion which tapers to define an inlet adapted for connection to
said tube.
6. The appliance defined in claim 5 in which said end wall inlet
portion defines an outwardly extending, annular retaining rib.
7. The appliance defined in claim 6 in which said tube defines a
plurality of inlet openings extending laterally therethrough.
8. A pressure-absorbing appliance for treatment of hydrocephalus by
relieving excessive pulsatile pressure of cerebrospinal fluid in a
brain ventricle, comprising:
a housing adapted for skull implantation;
resilient means supported in the housing and having an internal
expansible chamber with a normal volume when filled with
cerebrospinal fluid at static pressure, and an expanded volume when
the fluid pressure tends to increase due to ventricular pulsation,
the chamber having a single inlet opening; and
a tube connected to the resilient means in fluid communication with
the chamber inlet opening, and extending from the resilient means
and housing for insertion in the ventricle;
the chamber being closed except for the inlet opening so fluid in
the appliance is isolated from the housing, and the housing,
resilient means and tube being made of body-compatible materials
suitable for implantation.
9. The appliance defined in claim 8 in which the resilient means
includes a metal element usable as a portion of a capacitor whereby
motion of the resilient means arising from ventricular pulsation
can be monitored electrically.
Description
BACKGROUND OF THE INVENTION
Hydrocephalus is a brain condition in which cerebrospinal fluid
accumulates at abnormally high pressure in ventricles or chambers
within the brain. The ventricles expand in response to the pressure
exerted by the fluid, and surrounding brain tissue is compressed
between the ventricles and the skull. Hydrocephalus usually occurs
in babies or young children, and, if unchecked, results in brain
damage, enlargement and deformation of the head, and eventual
death.
One technique for treating hydrocephalus involves surgical
insertion of a drainage tube which couples the brain ventricles to
the jugular vein so excess cerebrospinal fluid in the ventricles is
drained into the venous system of the body. Several forms of
appliances useful in this technique are shown in U.S. Pat. Nos.
2,969,066, 3,020,913, and 3,111,125. There remains, however, a need
for improved treatment techniques and appliances which avoid long
lengths of tubing susceptible to clogging, which are simpler to
install and maintain, and which are directed to the root cause of
excessive fluid pressure in the brain ventricles.
Recent research on hydrocephalus indicates that static pressure of
ventricular fluid is influenced by periodic variation in fluid
pressure arising from a pulsatile expansion of a bed of capillaries
in the ventricles and known as the choroid plexus. It is thought
that hydrocephalus stems from a malfunction of natural
cerebral-circulation mechanisms which normally absorb energy
arising from physical pulsation of the choroid plexus. Research
results indicate that static pressure in the brain ventricles can
be reduced and controlled if the pulsatile pressure peaks are
absorbed or otherwise suppressed.
The appliance of this invention limits and absorbs the increase in
ventricular-fluid pressure arising from choroid-plexus pulsation,
and thereby provides indirect control and reduction of static
pressure in the ventricle. The appliance is intracranial and does
not require internal or external tubes leading to the jugular vein
as in presently known devices described in the aforementioned
patents. Installation is accomplished by relatively straightforward
surgical techniques, and the appliance is left in place permanently
or until the patient no longer exhibits symptoms of
hydrocephalus.
SUMMARY OF THE INVENTION
Briefly stated, the invention relates to a pressure-absorbing and
energy-dissipating appliance for relieving excess fluid pressure in
a body cavity such as a brain ventricle. The appliance includes a
housing adapted to be secured in the body as by implantation in the
skull. A resilient chamber-defining means such as an expansible
bellows is supported within the housing, and has an internal
chamber of variable volume. The chamber is resiliently expansible
and has a normal volume when filled with fluid at a static
pressure, and an expanded volume when the fluid pressure tends to
increase in pulsatile fashion. A tube is connected to the resilient
means in fluid communication with the chamber, and the tube extends
from the resilient means and housing for insertion in the body
cavity.
Preferably, both the housing and the resilient means include
aligned portions defining self-sealing diaphragms through which a
hypodermic needle can be inserted to extend into the expansible
chamber. The appliance is formed of materials which are compatible
with the body so the appliance may be implanted on at least a
semipermanent basis. An annular flange extends outwardly from an
outer end of the housing to rest against the skull or other bone
structure, and holes are provided in the flange to receive
ligatures for securing the appliance in place.
BRIEF DESCRIPTION OF THE DRAWINGS
The invention will be described in detail with reference to the
attached drawings, in which:
FIG. 1 is a side view, partly in section, of a child's head and
showing a skull implantation of an appliance according to the
invention;
FIG. 2 is an enlarged view of the skull showing the appliance ready
to be ligated in place; and
FIG. 3 is an elevation, partly broken away and in section, of the
appliance.
DESCRIPTION OF THE PREFERRED EMBODIMENT
A pressure-absorbing appliance 10 according to the invention is
shown in detail in FIG. 3. The appliance includes a housing 11
having a cylindrical sidewall 12. An annular groove 13 is formed in
the inner surface of the inner or distal end of sidewall 12, and an
outer end of the sidewall is partially closed by a radially
inwardly extending annular flange 14 having a central circular
opening 15 therethrough. Flange 14 is stepped to define an annular
shoulder 16. An annular attachment flange 17 extends radially
outwardly from the outer end of housing 11, and has a plurality of
ligature holes 18 therethrough.
An expansible chamber-defining means such as a bellows 21 is
mounted within housing 11. The bellows is of conventional
accordian-pleat construction, and is closed at one end by an
integral end wall 22 which tapers longitudinally away from the
bellows to define a hollow inlet tube 23. An annular retaining rib
24 extends from the surface of the tube adjacent its end. As seen
in FIG. 3, the folds or annuluses of bellows 21 have an outside
diameter smaller than the inside diameter of sidewall 12 of the
housing, and the bellows can therefore expand or contract freely in
response to internal pressure variations without binding or
dragging on the inner surface of the sidewall. End wall 22, on the
other hand, has an outside diameter slightly larger than the inside
diameter of sidewall 12, and is adapted to snap into groove 13 of
the sidewall in detent fashion to retain the bellows within the
housing.
A ventricular probe or tube 27 has a first end 28 which makes a
snug slip fit over inlet tube 23 and retaining rib 24. First end 28
is secured to the inlet tube by a pair of ligatures 29 which are
tied tightly around the assembled tubes during surgical
installation of the appliance. A distal second end 30 of tube 27 is
closed, but a plurality of lateral openings 31 (typically about 1
millimeter diameter) extend through the wall of the tube adjacent
the second end. Openings 31 are in communication through the hollow
interior of tube 27 with the expansible chamber defined by the
hollow interior of bellows 21.
The outer end of bellows 21 is closed by a circular sheet or
diaphragm 34 of a self-sealing material such as silicon rubber sold
under the trademark "Silastic." A housing diaphragm 35, formed of
the same material as diaphragm 34, is seated on flange 14 within
annular shoulder 16, and extends across central opening 15 of the
housing. The purpose of diaphragms 34 and 35 is to permit a
physician to insert a hypodermic needle therethrough into the
interior chamber of bellows 21 when the appliance is installed.
Medication may thereby be introduced into the cerebral spinal fluid
within the bellows, or fluid can be withdrawn for analysis. The
patency of the system can also be evaluated by this technique, and
any obstructions in tube 27 can be flushed clear. A clearance of
0.05 inch or more exists between diaphragm 34 and inwardly
extending flange 14 such that the bellows can expand longitudinally
when subjected to pulsatile pressure.
The entire appliance, which is intended for a long term
implantation, is of course constructed from materials which are
compatible with the human body. Plastic material as sold under the
trademark "Teflon" is satisfactory for forming housing 11 and
bellows 21. The bellows and housing may also be made of stainless
steel or gold-plated nickel if metal construction is preferred.
Ventricular tube 27 is preferably formed from tubing of plastic
material sold under the trademark "Silastic."
In a typical appliance, sidewall 12 of housing 11 has a diameter of
about three-eighths to one-half inch, and attachment flange 17 has
a diameter about three-sixteenths inch larger than the diameter of
the sidewall. The sidewall is approximately one-fourth inch long,
and ventricular tube 27 is typically 1 to 2 inches long. A tube
with an outside diameter of 3 millimeters and a bore of 2
millimeters has been found satisfactory for the appliance.
Diaphragms 34 and 35 should be relatively thick for proper
self-sealing action after being punctured by a hypodermic needle,
and a thickness of about 3 millimeters provides satisfactory
results.
Bellows 21, in a typical appliance, has an internal volume of about
0.25 cubic centimeters when filled with cerebrospinal fluid at a
normal static pressure of about 15 to 25 millimeters of water. The
ventricular volume change during pulsation of the choroid plexus is
relatively small, and it is adequate in most cases if the bellows
has approximately a 50 percent internal volume expansion when
subjected to fluid pressure of say 15 to 20 times the normal static
pressure.
Referring to FIGS. 1 and 2, the pressure-absorbing appliance is
installed using conventional surgical techniques. A posterior
parietal-occipital inverted-horseshoe-shaped scalp flap 39 is
turned, and a standard trephine opening 40 is made in skull 41 of
the patient, the opening having a diameter slightly larger than the
outside diameter of sidewall 12 of the appliance. Small holes 42
are drilled at the edge of the trephine opening to receive
retention ligatures, and 3-0 silk sutures (not shown) are passed
through the holes. The dura mater of the brain is then incised, and
the cortex is lightly coagulated.
A ventricular cannula (not shown) is next passed into the lateral
ventricle of the brain, and is then withdrawn. Ventricular tube 27
is next passed along the cannula-formed tract into a lateral
ventricle 45 of the brain. The outer end of the tube is then cut to
length and secured over inlet tube 23 by ligatures 29 which are
typically 3-1 silk ligatures. The previously placed silk retention
ligatures are then passed through ligature holes 18 in the
attachment flange of the housing, and the housing is tied into
place on the skull. The appliance is then checked for proper
function by ascertaining patency of the tube by passing a -26
hypodermic needle through the diaphragms.
When so installed, the bellows of the appliance is immediately
filled with cerebrospinal fluid 46 which flows from the ventricle
through openings 31 and the bore of tube 27 into the internal
chamber defined by the bellows. The bellows then expands slightly
to define a normal internal volume in response to the static
pressure exerted by the cerebrospinal fluid. Upon pulsation of the
choroid plexus the pressure of the fluid tends to rise due to the
slight reduction in ventricular volume, but an excessive pressure
increase is prevented by the resulting expansion of the bellows
which compensates for the reduced volume of the ventricle.
The bellows is more resilient than brain tissue 47 surrounding the
ventricle, and the bellows chamber therefore expands to compensate
for reduced ventricular volume. The high fluid-pressure pulsatile
peaks which characterize hydrocephalus are thus suppressed, and it
has been found that this produces a beneficial effect which tends
to lower an excessively high static pressure within the ventricle.
Energy is also dissipated from the overall system by the work done
in flexing of the bellows, resulting in damping of the excessive
energy created by the choroid plexus.
Bellows motion and displacement can be sensed electrically if the
bellows includes a metal component or element usable as one plate
of a capacitor. For example, a metal-foil disc 49 can be secured to
bellows diaphragm 34 as shown in FIG. 3. The disc is centrally
apertured to provide clearance for a hypodermic needle introduced
through diaphragms 34 and 35. An external electrode (not shown) is
secured over diaphragm 35, and the capacitance of the resulting
parallel-plate capacitor is measured using conventional techniques.
Bellows movement is manifested by a variation in capacitance
arising from a change in spacing of the disc and electrode.
Although the invention has been described in a presently preferred
form, it will be clear that the inventive concept can be
incorporated in other specific types of apparatus. For example, an
expansible balloonlike reservoir can be substituted for bellows 21,
or other types of expansible chamber-defining means can be used. As
another example, a spring-loaded piston in a cylinder is useful to
define an expansible chamber, and further damping of the system can
be obtained by bypassing part of the fluid past the piston and
returning the bypassed fluid to the ventricle in a return line.
Similarly, different types of skull-attachment plates can be used
to implant the appliance in the skull. It is intended that all such
variations and modifications be encompassed within the scope of the
following claims which define the invention in detail.
* * * * *