U.S. patent number 3,901,245 [Application Number 05/341,774] was granted by the patent office on 1975-08-26 for bio-medical pressure control device.
This patent grant is currently assigned to Bio-Medical Research, Ltd.. Invention is credited to Richard E. Brenz, Charles C. Hansford, Gene H. Samuelson, Eugene B. Spitz.
United States Patent |
3,901,245 |
Spitz , et al. |
August 26, 1975 |
Bio-medical pressure control device
Abstract
A cerebrospinal fluid anti-siphoning device for insertion into
the human body to provide regulation of fluid being transported
from the lateral ventricles to another part of the body. The device
includes a fluid housing member through which the cerebrospinal
fluid passes. The fluid housing member is adapted to contain a pair
of check valves which control fluid flow through the housing member
and prevent back flow from a downstream area to an upstream area. A
central chamber within the fluid housing member encloses a fluid
control mechanism which provides for termination of fluid flow when
the downstream pressure becomes too low with respect to the
upstream pressure. The fluid control mechanism includes a diaphragm
which is displaced from a fluid conduit when flow is passing
through the fluid housing member and is positioned contiguous to
the conduit opening when the downstream pressure is too low,
thereby effectively terminating the flow of the cerebrospinal fluid
through the fluid housing member. The device includes a mechanism
for manually actuating the flow through the outlet area of the
housing member even when the antisiphoning device has been
implanted within the human body.
Inventors: |
Spitz; Eugene B. (Media,
PA), Samuelson; Gene H. (Media, PA), Brenz; Richard
E. (Media, PA), Hansford; Charles C. (Chester, PA) |
Assignee: |
Bio-Medical Research, Ltd.
(Lima, PA)
|
Family
ID: |
23338983 |
Appl.
No.: |
05/341,774 |
Filed: |
March 15, 1973 |
Current U.S.
Class: |
604/10;
137/510 |
Current CPC
Class: |
A61M
27/006 (20130101); Y10T 137/7836 (20150401) |
Current International
Class: |
A61M
27/00 (20060101); A61m 027/00 () |
Field of
Search: |
;128/35R,35V
;137/510 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Maleson; Paul Rosenberg; Morton
J.
Claims
What is claimed is:
1. A cerbrospinal fluid anti-syphoning device comprising:
a. fluid housing means having a central chamber, said fluid housing
means including a flexible dome forming an upper surface of said
central chamber, said flexible dome adapted to be depressable into
said central chamber for increasing fluid pressure therein;
b. inlet means in fluid communication with said central chamber for
insertion of said fluid into said chamber;
c. outlet means in fluid communication with said central chamber
for transport of said fluid from said chamber;
d. fluid egress conduit means extending internal said central
chamber and in fluid communication with said outlet means;
e. flexible diaphragm means forming a lower continuous surface of
said central chamber, said diaphragm means being positionally
located adjacent said fluid egress conduit means, said diaphragm
means adapted to block flow of said fluid through said fluid egress
conduit means when a fluid pressure differential between said inlet
and outlet means is less than a predetermined value; and,
f. diaphragm restraint means secured to said housing and positioned
below said diaphragm means for preventing said flexible diaphragm
means from being externally displaced from said housing means when
said flexible dome is depressed, said diaphragm restraint means
being a plate member having at least one opening passing
therethrough.
2. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said flexible diaphragm means is displaced from said
fluid conduit means when said pressure differential between said
inlet means and said outlet means is less than a predetermined
value and said fluid is being transported through said central
chamber.
3. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said flexible diaphragm means is contiguous to a
fluid passage opening of said fluid conduit means when said
pressure differential between said inlet means and said outlet
means exceeds said predetermined valve thereby blocking flow of
said fluid to said outlet means.
4. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said fluid egress conduit means includes an L-shaped
conduit having a first end connected to and in fluid communication
with said outlet means and a second end adjacent said diaphragm
means forming a fluid passage opening for transport of said fluid
within said chamber to said outlet means.
5. The cerebrospinal fluid anti-siphoning device as recited in
claim 4 where said second end of said conduit provides a contact
area with said diaphragm means greater than the flow area of said
fluid through said conduit.
6. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said valve means is constructed of silicone.
7. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said flexible dome is adapted to be compressed into
said chamber for increasing the fluid pressure within said chamber
thereby displacing said fluid through said outlet means.
8. The cerebrospinal fluid anti-siphoning device as recited in
claim 7 where said flexible dome is constructed of silicone
rubber.
9. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said diaphragm restraint means includes a plate
member displaced from said diaphragm means, said plate member being
fixedly secured to said fluid housing means.
10. The cerebrospinal fluid anti-siphoning device as recited in
claim 9 where said plate member includes a plurality of openings
passing therethrough.
11. The cerebrospinal fluid anti-siphoning device as recited in
claim 10 where said plate member is constructed of nylon.
12. The cerebrospinal fluid anti-siphoning device as recited in
claim 1 where said diaphragm restraint means includes a grid member
mounted to said fluid housing means.
13. The cerebrospinal fluid anti-siphoning device as recited in
claim 12 where said grid member is constructed of nylon.
14. The cerebrospinal anti-siphoning device as recited in claim 1
including inlet valve means inserted within said inlet means of
said fluid housing means for transporting said fluid into said
central chamber when said inlet fluid pressure is in excess of a
predetermined value.
Description
INCORPORATION BY REFERENCE
This application incorporates by reference U.S. Pat. No. 3,566,875
issued Mar. 2, 1971.
BACKGROUND OF THE INVENTION
1. Field of the Invention
The present invention pertains to devices for draining
cerebrospinal fluid during treatment of hydrocephalus.
2. Prior Art
Devices for draining cerebrospinal fluid are known in the art.
However, in some prior devices one way check valves are
incorporated to promote drainage of the cerebrospinal fluid. Such
valves fluidly communicate with the brain area and other parts of
the body to which the fluid is being drained. However, a rapid
decrease in the pressure of the parts of the body to which the
fluid is being drained may cause too much fluid to be transported
from the brain in a manner which is too rapid. Such a condition may
have diliterious results and possibly cause death of the patient
within which the prior devices have been implanted. Such prior
devices do not include a mechanism whereby the fluid flow may be
terminated when the downstream pressure or pressure of the body to
which the fluid is being drained becomes too low with respect to
the upstream fluid pressure. Such prior devices do not provide
automatic control of the fluid being drained dependent upon the
pressure differential experienced by the devices.
SUMMARY OF THE INVENTION
A cerebrospinal fluid anti-siphoning device which comprises a fluid
housing mechanism having a central chamber. An inlet mechanism is
in fluid communication with the central chamber for insertion of
the fluid into the chamber. The device includes an outlet mechanism
in fluid communication with the central chamber for transport of
the fluid from the chamber. Further, the device includes a
mechanism for controlling the flow of the cerebrospinal fluid
through the central chamber of the fluid housing mechanism
responsive to a predetermined pressure differential between the
inlet mechanism and the outlet mechanism.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a view of the cerebrospinal fluid anti-siphoning device
implanted within a human body;
FIG. 2 is a blow out view of the anti-siphoning device;
FIG. 3 is a top view of the anti-siphoning device;
FIG. 4 is a sectional view of the anti-siphoning device taken along
the section lines 4--4 of FIG. 3.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring now to FIGS. 1, 2, and 3, there is shown cerebrospinal
fluid anti-siphoning device 11 for insertion into the human body.
Device 11 is provided to control passage of cerebrospinal fluid
being transported from an upstream to a downstream area 13, 15
respectively. Device 11 forms a mechanism whereby the fluid
pressure differential between upstream and downstream conditions
may be effectively monitored, such that when the fluid pressure
differential surpasses a predetermined value, the flow of fluid
passing through device 11 is terminated. In general, the pressure
of the fluid entering inlet tube 17 is higher than the pressure of
the fluid egressing from device 11 through outlet tube 19. This
pressure differential provides for a flow of the fluid from
upstream 13 to downstream 15 through device 11. However, it should
be understood that where the pressure differential exceeds a
predetermined value, excessive drainage of the fluid from the brain
area may be encountered. It is the purpose of device 11, as will be
described in the following paragraphs, to terminate the flow of the
fluid when the pressure differential exceeds the prescribed
value.
It is to be understood that device 11 includes upstream check valve
22 and downstream check valve 24 inserted into upstream and
downstream inlet and outlet areas 21 and 23 respectively. Check
valves 22 and 24 are similar in construction to those valves shown
and described in U.S. Pat. No. 3,566,875 which is herein
incorporated by reference. In general, each of check valves 22, 24
shown and described in the referenced patent includes an inner
elastic tubular member within an outer tube. Formed in the region
of the downstream end of each inner tubular member is an axially
extending slit which forms a valve opening. The valves are designed
to automatically open when the pressure within each inner tubular
member exceeds the pressure at the exterior thereof by a given
slight amount. The referenced slit automatically opens due to this
pressure differential while automatically closing when the internal
pressure is less than the external pressure of each tubular member
by less than that pressure required to open the slit.
In general, device 11 is positionally located within the human body
adjacent skin area 25. Device 11 is further positioned in the
clavicle area of the human body with inlet tube 17 passing to the
lateral ventricals within the skull for drainage of the
cerebrospinal fluid therefrom. Outlet tube 19 of device 11 passes
to another portion of the body such as the peritoneal cavity to
permit drainage of the fluid thereto.
Cerebrospinal fluid anti-siphoning device 11 includes fluid housing
member 27 having central chamber or cavity 29 through which the
fluid flows. In a top cross-section, housing member 27 is similar
in geometrical contour to a diamond or rhomboid, however, such is
not critical to the inventive concept as herein described. Housing
member 27 may be formed of medical grade silicone rubber or some
like material adapted for insertion into the human body with the
only restriction being that such material does not degrade within
the environment where it is positioned, as well as contaminate the
body or fluid passing therethrough. Inlet area 21 of fluid housing
member 27 is connected to inlet tube 17 and is in fluid
communication with central chamber or cavity 29 for insertion of
the fluid passing from the brain area through inlet tube 17 into
chamber 29. In similar fashion, outlet area 23 is connected to
outlet tube 19 and is in fluid communication with chamber or cavity
29 for transport of the fluid from chamber 29 through outlet tube
19 to the peritoneal cavity or other area of the body so designated
to receive the excessive cerebrospinal fluid being transported
through device 11. Inlet and outlet tubes 17, 19 may be constructed
of polyethylene or some like material which will remain
substantially inert with respect to the body environment through
which they pass. Located within fluid housing member 27 and
further, within cavity 29 there is fluid control mechanism 31 for
controlling or regulating the flow of the cerebrospinal fluid
through central chamber 29 responsive to a predetermined pressure
differential between inlet or upstream condition 13 and outlet or
downstream condition 15.
Fluid control mechanism 31 describes a valve mechanism within
chamber 29 for terminating the flow of fluid from inlet area 21 to
outlet area 23 when the pressure differential between the inlet and
outlet areas 21, 23 exceeds a predetermined value. This valve
mechanism includes fluid egress conduit 33 within fluid housing
member 27 which is in fluid communication with outlet area 23 for
passage of fluid into downstream valve 24. Further, the
aforementioned valve mechanism includes flexible diaphragm
mechanism 35 which forms a lower surface of central chamber 29 and
is positionally located adjacent to fluid conduit 33 as is shown in
the figures.
As will be described in the following paragraphs, flexible
diaphragm 35 may be displaced away from egress conduit 33 when
fluid is passing through device 11 which would result when the
pressure differential between the inlet area 21 and outlet area 23
is less than a predetermined value. Further, when the pressure
differential exceeds the predetermined amount diaphragm 35 is
opposingly drawn into contiguous relation with conduit opening 37
thereby blocking the passage of fluid through conduit 33 into
outlet area 23 and downstream valve 24 for displacement through
outlet tube 19. In general, fluid conduit 33 is L-shaped in
geometrical contour and has a first end 39 which is in fluid
communication with outlet area 23 and a second end 41 which has
conduit opening 37 for passage of the fluid. The displacement
distance between diaphragm 35 and second end 41 of conduit 33
provides a continuous fluid passage opening for transport of the
fluid from inlet area 21 through fluid housing member 27 and
finally to outlet area 23. As is seen in the figures, second end 41
includes lip section 43 which provides the area of contact when
flexible diaphragm 35 is drawn into a blocking mode of operation.
Lip section 43, as is seen, provides a slightly flared section and
is upturned slightly with respect to the remaining wall section of
fluid conduit 33. Diaphragm 35 is mounted within fluid housing 27
either through bonded securement or through insertion in a recess
therein provided. In this manner, diaphragm 35 may be movably
displaced in an upward or downward direction dependent upon the
pressure condition it experiences.
In operation, fluid control mechanism 31 may be seen to function in
a plurality of states. Assuming that all the pressures in upstream
and downstream areas 13, 15 are equal, it is to be understood that
diaphragm 35 will lie substantially contiguous with second end 41
of conduit 33. When device 11 is inserted into the human body or
otherwise when the pressure of inlet area 21 exceeds outlet area 23
within a predetermined range, flow is initiated through inlet tube
17 into cavity 29. This causes a pressure to be exerted downwardly
on diaphragm 35 thus displacing diaphragm 35 away from conduit
opening 37. Since the downstream 15 pressure is less then the
upstream 13 pressure, fluid flows into conduit opening 37 and
through conduit 33 to outlet area 23. However, where the downstream
15 pressure drops to a low level with respect to upstream 13
pressure, diaphragm 35 is pulled upwardly into contiguous contact
with section 43 of second end 41 of conduit 33. Once diaphragm 35
is contiguously in relation with second end 41, flow of fluid
through egress conduit 33 is effectively blocked and flow is
terminated from inlet tube 17 to outlet tube 19. As was the case in
the construction of fluid housing member 27, both flexible
diaphragm 35 and fluid egress conduit 33 are similarly constructed
of a medical grade silicone rubber or some like material.
As is shown in the figures, fluid housing member 27 includes
flexible dome 43 extending above upper surface 45. Dome 43 is mated
to housing 27 through insert into a recess, or affixedly secured by
bonding or some combination thereof. Dome 43 forms an upper surface
of chamber 29 and is hat-shaped in geometrical contour. Dome 43 is
further positionally located adjacent outer skin surface 25 when
device 11 is implanted within the body. Dome 43 is flexibly
constructed of a medical grade silicone rubber or some like
material and is adapted to be compressed into chamber 29 for
increasing the fluid pressure within chamber 29 thereby allowing
manual displacement of diaphragm 35 away from conduit opening 37 to
permit transport of the fluid through outlet area 23. In order to
give structural support to housing member 27 surface 47 may by
interspersed between the area under dome 43 and fluid control
mechanism 31. However, in this form, fluid communication is
maintained between dome 43 and control mechanism 31 through
openings 48 passing through surface 47 and thus, allowing fluid or
air to pass therethrough when dome 43 is depressed. Thus, it is
seen that where diaphragm 35 is in contiguous relation with conduit
opening 37 of egress conduit 33, no flow passes into outlet area
23. This condition may occur through a number of ways, such as the
pressure differential between outlet and inlet areas 21, 23 being
too great or through possible debris found in the cerebrospinal
fluid. Where such is the case and it is desired to flush the system
or otherwise to initiate the flow between upstream 13 and
downstream 15, dome 43 may be depressed thereby increasing the
pressure against flexible diaphragm 35 and displacing it away from
fluid egress conduit opening 37. In this case, fluid then begins to
flow through conduit 33 through manual actuation of the depression
of dome 43.
Device 11 includes diaphragm restraint mechanism 49 secured to
fluid housing member 27 below diaphragm 35. Restraint member 49 is
displaced from diaphragm 35 through a predetermined amount to
permit a flexible movement of diaphragm 35 upwardly or downwardly.
Restraint member 49 is secured to housing 27 through fixed
securement such as bonding or insertion into a recess, or a
combination of such means. In general, restraint member 49 may be a
plate element having openings 51 formed therethrough. Plate 49 is
constructed or formed of nylon or some like material. As has been
described, restraint member 49 may be a plate member having
openings 51 or may be formed in a grid type shape. The purpose of
plate 49 is to prevent diaphragm 35 from being blown out of housing
member 27 when dome 43 is compressed. When dome 43 is depressed a
relatively high pressure impinges upon diaphragm 35 and forces it
in downward displacement wherein it is restrained through contact
or interaction with plate 49. Openings 51 in plate 49 provide for
the displacement of any fluid through those openings when diaphragm
35 is downwardly displaced. This insures that diaphragm 35 does not
remain rigidly displaced with respect to plate 49 through the
damping of the fluid or other material therebetween, and permits
free movement of diaphragm 35 responsive to the fluid pressure.
Normal fluid pressure in the brain area is generally equal to or
greater than 200 mm. of water. However, in the case of
hydrocephallus, the fluid pressure in the brain may exceed normal
values. For this reason upstream and downstream valves 22 and 24
provide a means whereby fluid may be drained from the brain.
However, where the pressure in the outlet area 23 becomes to low,
too much fluid may possibly be drained off and the drainage may be
too rapid. Thus device 11, within which valves 22 and 24 are
inserted, may be constructed to terminate the flow of cerebrospinal
fluid when the downstream pressure becomes too low.
Through proper construction and positional relationships of
diaphragm 35 with respect to conduit opening 37, device 11 can be
made to terminate fluid flow throughout a wide range of downstream
pressures. Generally, device 11 is constructed to terminate flow
when the downstream pressure drops to 20-90 mm. of water. As an
example, diaphragm 35 has a thickness approximately within the
range of 0.005-0.01 inches in thickness and is so constructed as to
be displaced from second end 41 approximately 0.004-0.020 inches
when fluid is flowing therethrough. Further, as an example, plate
49 may have an approximate thickness of 0.050 inches and include an
approximate diameter of 0.50 inches. It is to be understood that
the foregoing examples of dimension and positional relations are
used for illustration only and that control of fluid flow
termination may be regulated over a wide range of pressures by
changing construction geometries.
* * * * *