U.S. patent number 3,910,283 [Application Number 05/404,345] was granted by the patent office on 1975-10-07 for process for treatment of ascites and device to accomplish same.
Invention is credited to Harry H. Leveen.
United States Patent |
3,910,283 |
Leveen |
October 7, 1975 |
Process for treatment of ascites and device to accomplish same
Abstract
A method for the transfer of body fluid which accumulates in the
peritoneal cavity into the vascular system is disclosed. This
accumulation occurs most frequently with patients suffering from
cirrhosis of the liver and constitutes a lethal complication. An
implant device is disclosed which comprises a plastic chamber and
connecting tubing, said chamber containing unique valve structure
comprising a flexible diaphragm seated on a shoulder and attached
to this diaphragm a connector bar which is attached at its other
end to the center plate of a structure composed of several lateral
silicone rubber struts which radiate out from the center plate to
connect to a circular peripheral ring. The circular peripheral ring
is anchored fixedly to the lateral wall of the valve housing by
compression between two threaded connectors of plastic also. These
rubber struts place pressure constantly on the diaphragm pulling it
toward the shoulder which closes the valve. The diaphragm member is
thus fixed to the side wall of the valve housing by the elastomeric
strut members. The seat of the diaphragm valve is adjustable and
hence it can control the fluid pressure required to open the
valve.
Inventors: |
Leveen; Harry H. (Brooklyn,
NY) |
Family
ID: |
23599245 |
Appl.
No.: |
05/404,345 |
Filed: |
October 9, 1973 |
Current U.S.
Class: |
604/9; 137/852;
604/502 |
Current CPC
Class: |
A61M
39/24 (20130101); A61M 27/006 (20130101); A61M
2039/2433 (20130101); Y10T 137/7888 (20150401); A61M
2039/242 (20130101); A61M 2202/0401 (20130101); A61M
2039/244 (20130101); A61M 2202/0464 (20130101) |
Current International
Class: |
A61M
27/00 (20060101); A61M 39/00 (20060101); A61M
39/24 (20060101); A61M 027/00 () |
Field of
Search: |
;128/35V,247,35R,232
;137/515.5,525.3 ;251/331,342 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
The Lancet, Vol. 1 (64) 7326, p. 202-Jan. 25, 1964. .
Journal of Neurosurgery, 1968, Vol. XXVIII, No. 3, pp. 283-287 -
Initial Experience with Hakim Valve for Ventriculovenous Shunt -
Robt. Gojemann..
|
Primary Examiner: Medbery; Aldrich F.
Claims
I claim as my invention:
1. I claim a method for the transfer of body fluids which
accumulates in the peritoneum cavity and into the vascular system
which comprises passing fluid through a connecting tube into the
inlet chamber of a hollow plastic implanted valve, causing that
valve to open and passing the fluid under pressure into a second
reservoir from where the fluid is conducted through a second
section of tubing which tubing is connected to the jugular vein of
the patient.
2. A device for use in the method of claim 1 which comprises a
plastic housing having connected on opposing surfaces, thereof an
inlet tube and an outlet tube respectively said inlet tube opening
on one end into the peritoneum and on the other end into an inlet
reservoir located within said housing, said reservoir having a
pressure movable wall which comprises a flexible diaphragm which
rests against a valve seat and which diaphragm moves away from said
valve seat in response to pressure exerted thereon to permit flow
of the body fluid from the peritoneum through the valve housing and
into the outlet tube and jugular vein.
3. A device according to claim 2 wherein said pressure movable wall
comprises the shape of an inverted cup and said cup is connected to
a permanently attached valve support member.
Description
BACKGROUND OF THE INVENTION
Ascites is a serious medical malady characterized by an
accumulation of body fluid in the peritoneal cavity. Acitic fluid
as it is called accumulates most frequently with patients who have
cirrhosis and unless corrected can cause death. This fluid which
accumulates is rich in body building protein and unless recovered
the patient suffers from wasting malnutrition.
There is no known adequate therapy at present to induce
readsorption or excretion of the ascitic fluid once it is
generated. Diuretic therapy and restriction of the patient's salt
intake can slow the accumulation of fluid but can do nothing about
recovery of the fluid or removal from the body once it is formed.
Under current techniques the only means employed in such cases is
repeated paraceutesis to empty the peritoneal cavity of its
accumulated fluid. But abviously this induces a loss of the fluid
and its valuable body proteins.
A second clinical situation in which an abnormal amount of fluid
collects in the body cavity is hydrocephalus. In this condition
fluid accumulation occurs in a ventricle of the brain and the
excess of fluid tends to compress the brain tissue.
Ideally both of these fluids should be returned to the circulating
blood stream or in the case of the hydrocephalic fluid to the
peritoneal cavity where it is not so great in quantity that unlike
the acitic fluid it can be absorbed by the tissue. The aforesaid
device and method of its use makes both fluid transfer objectives
attainable and comprise the subject matter of this invention as
will be described in elaborate detail below.
BRIEF DESCRIPTION OF THE INVENTION
A device is described which can be permanently implanted into the
human body and employed as a one way valve so that accumulated
acitic fluid can be drained through a silicone rubber tubing from
the peritoneal cavity into the blood stream without danger of the
blood leaking back in the tube from the circulation into the
peritoneum.
The valve mechanism and structure of my device has been designed to
meet certain requirements. First it must be positive in action and
the closure of the valve cannot depend upon flow of fluid alone
because low flow rates may not be sufficient to close the valve
when required. Significantly the reverse flow of even a small
amount of blood from the circulation into the silicone tubing would
clog the tubing since the blood would undergo thrombosis.
Second therefore the valve must normally be in a closed position
and differential pressure must be employed as the actuating means
to cause the valve to open and close. In practice a pressure
differential of at least one or two centimeters of H.sub.2 0 must
exist between the venous and peritoneal fluid pressures before the
valve will open and permit the peritoneal fluid to flow into the
venous system. When this pressure differential disappears the valve
closes.
The aforesaid mode of operation acts as a safeguard against back
flow of blood and consequent thrombosis of the conduit. In addition
this also slows down the delivery of fluid as the venous pressure
of the receiving system rises. This prevents a sudden overloading
of the circulatory system with acitic fluid. Collaterally, a
normally closed valve allows the fluid accumulation to be
maintained at a pressure above the venous pressure. This latter
attribute is particularly important in relief of hydrocephalis
where the reduction of the ventricular pressure to very low levels
causes sagging of the brain tissue.
The device of the invention has a valve structure constructed of
inert plastic and silicone rubber both of which materials are
compatible with tissue. The device will be further described by
reference to the
FIG. 1 of the attached drawing of a cross sectional view of the
device and
FIG. 2 which is an exploded view.
In the drawing FIG. 1 it can be seen that the device comprises a
plastic housing 1 which contains an inlet tube 2 coming from the
peritoneum and an outlet tube 3 going into the jugular or some
other large vein. Inside the plastic housing a molded lip 16
extends out from the interior of the housing wall at the end
proximate to the inlet 2 and its extension forms a circular valve
seat 4. A silicone rubber inverted cup structure comprises the
valve disphragm 5. The valve diaphragm has a central connecting bar
6 which attaches at its opposite end to a wheel like arrangement
which acts as a support means for the valve. The central connecting
bar 6 attaches to a center plate 7 which has several radiating
struts 8 which extend out from the central plate to a peripheral
support ring 9 which fits compressively into an attachment groove
or slot 10 in the wall of the housing 1. The support ring 9 is held
compressively in the groove 10 by an interior threaded connector 11
which has also an attachment shoulder 12 in the wall of the housing
to attach tubing which shoulder is located distal to the fluid
inlet 13 which introduces the ascites fluid into the valve
chamber.
After the fluid from the peritoneum enters the fluid inlet 13 which
is usually a polyethylene tubing it passes into the inlet tube 2
which emptys it into an inlet reservoir 14. When the fluid pressure
in the inlet reservoir 14 builds up to a significant level it
forces the upward movement of the connecting bar 6 and diaphragm 5
because of the fluid pressure exerted on the center plate 7 by the
fluid collected in the fluid actuating column 17. Since the
circular peripheral ring 9 is fixed in its position the upward
movement of the central valve bar 6 causes the diaphragm 5 to move
upward and out of its valve seat 4 and permits the fluid to flow in
column 17 under the diaphragm 5 and around the same into a central
collecting cavity 18 from where the fluid passes through the
opening 19 which appear between the radial struts 8 of the support
wheel. From there the fluid passes into the outlet reservoir and
into the outlet tube and into the fluid outlet 20 which is
polyethylene tube which is inserted into a large jugular vein or
other large artery for passage of the fluid into the vascular
system.
Continuing with the description of the operation of the device and
still refering to FIGS. 1 and 2 it should be noted that the passage
of fluid through the valve halts when the pressure against the
valve created by the inlet fluid drops below a certain level. This
causes the diaphragm 5 to return to its abutment against the valve
seat 4 and once again closes the valve.
While the aforesaid disclosure will certainly suggest to those
reading the same many variations in structure of the same it is
applicants intention to claim the concept which is essentially
defined in the following claims.
* * * * *