U.S. patent number 3,707,967 [Application Number 05/077,240] was granted by the patent office on 1973-01-02 for steady flow regenerative peritoneal dialysis system and method.
This patent grant is currently assigned to Tecna Corporation. Invention is credited to Sotiris Kitrilakis, Thomas Charles Robinson.
United States Patent |
3,707,967 |
Kitrilakis , et al. |
January 2, 1973 |
STEADY FLOW REGENERATIVE PERITONEAL DIALYSIS SYSTEM AND METHOD
Abstract
A steady-flow regenerative peritoneal dialysis system and method
making use of permanent percutaneous tubes extending into the
abdominal cavity and means for circulating a dialysate through the
abdominal cavity and reconstituting the dialysate.
Inventors: |
Kitrilakis; Sotiris (Berkeley,
CA), Robinson; Thomas Charles (El Cerrito, CA) |
Assignee: |
Tecna Corporation (Berkeley,
CA)
|
Family
ID: |
22136901 |
Appl.
No.: |
05/077,240 |
Filed: |
October 1, 1970 |
Current U.S.
Class: |
604/29;
604/175 |
Current CPC
Class: |
A61M
1/284 (20140204); A61M 1/1696 (20130101); A61M
1/281 (20140204); A61M 1/285 (20130101); A61M
1/1674 (20140204); A61M 1/28 (20130101) |
Current International
Class: |
A61M
1/28 (20060101); A61M 1/16 (20060101); A61m
005/00 () |
Field of
Search: |
;128/213,214R,348,1R
;210/321 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Gordon et al., Trans. Amer. Soc. Artif. Inter. Organs Vol. XV, 1969
(June) pp. 347-352. .
Shinaberger et al., Trans. Amer. Soc. Artif. Inter. Organs Vol. XI,
1965 pp. 76-81. .
Ersek et al., Trans. Amer. Soc. Artif. Inter. Organs Vol. XV, 1969,
pp. 267-271..
|
Primary Examiner: Truluck; Dalton L.
Claims
We claim:
1. A steady flow peritoneal dialysis system including in-flow and
out-flow conduits adapted to extend through the abdominal wall into
the abdominal cavity whereby dialysate fluid may be introduced into
and removed from the cavity, each of said conduits including an
external surface portion at the interface between the abdominal
wall and the conduits which is compatible with the skin,
subcutaneous tissue and other tissue, said surface including a
plurality of adjacent substantially discrete pockets having
openings which face in the direction of said skin and tissue, the
walls of said pocket extending inwardly to a depth in the range of
0.002 to 0.020 inches and being of such shape and size as to
provide means to accommodate a number of living cells sufficient to
provide anchoring but not so large as to prevent essentially normal
transfer of nutrients to the living cells in said pockets from
adjacent skin and tissue, means for supplying the dialysate fluid
to said in-flow conduit, means for causing the dialysate fluid to
flow through the cavity, and means for removing the dialysate fluid
from said out-flow conduit.
2. A system as in claim 1 in which said means for causing fluid to
flow comprises a sealed pump.
3. A system as in claim 1 in which said supply and removal means
includes a flow regulator.
4. A system as in claim 1 in which said supply means includes a
dialysate fluid source and said removal means includes a sink.
5. A system as in claim 1 in which said supply and removal means
includes means for reconstituting the dialysate fluid connected by
fluid conduits to said inflow and out-flow conduits.
6. A system as in claim 5 in which said reconstitution means
includes a column for the removal of uric acid and creatinine.
7. A system as in claim 5 including means for irradiating the
circulatory fluid with ultra-violet radiation.
8. A system as in claim 7 in which said reconstitution means
includes a filter adapted to receive the fluid flowing from the
irradiation means.
9. A system as in claim 5 in which said system is a closed
self-contained fluid system.
Description
BACKGROUND OF THE INVENTION
This invention relates generally to apparatus for treatment of
chronic kidney disease and more particularly to a peritoneal
dialysis system and method.
The dialysis process has become an effective means for treatment of
chronic kidney disease. Two types of dialysis are currently in use;
hemodialysis and peritoneal dialysis. In hemodialysis the blood is
removed from an artery or vein, dialyzed in an artifical kidney
machine external of the body and returned to a vein usually through
cannulas in the arm or leg. This type if dialysis involves
permanent connectors to major blood vessels for attachment of the
device and also requires the handling of blood in an external
prothesis.
The second type of dialysis which does not involve handling of
blood directly in a prosthesis is peritoneal dialysis. In this
method, dialysing fluid is introduced in the abdominal cavity
either through a puncture in the abdominal wall or through a
permanently installed percutaneous tube. The dialysate resides in
the cavity for a period of time (20 minutes to 1 hour) and is then
removed. While the fluid is in the cavity, it picks up urea and
other metabolic wastes from the blood stream by diffusion through
the walls of the blood vessels within the abdominal cavity. This
scheme of dialysis avoids the requirement of handling the blood and
invasion of the vascular system but requires the penetration of the
abdominal wall. Both types of dialysis require that the blood
stream be brought directly or indirectly in chemical equilibrium
with a very large quantity of dialysate. In addition to the waste
material picked up by the dialysate, a certain amount of proteins
and inorganic constituents capable of diffusing through the
hemodialysis membrane or the blood vessel walls are dissolved in
the dialysate fluid and lost. The systemic replacement capacity for
these substances may or may not be capable of maintaining
physiologic levels. When certain of these materials are depleted by
chronic dialysis over long periods of time, characteristic
pathologic symptoms often appear. The depletion of important trace
components is proportional to the total quantity of dialysate
used.
An additional serious difficulty with both types of dialysis is the
danger of infection, either at the sites of cannulation of arteries
and veins in the case of hemodialysis, or the penetrations through
the abdominal wall, temporary or permanent, in the case of
peritoneal dialysis. The large quantities of dialysate involved
must be maintained sterile during preparation and throughout the
diffusion process to avoid infecting the blood stream or the
peritoneal cavity.
As a consequence, elaborate cleaning and sterilization procedures
must be followed by hospital personnel or the patient himself while
connecting the cannulas or percutaneous in-flow out-flow tubes to
the dialysis equipment. Any laxities during the procedure can lead
to serious infection.
The equipment involved in both types dialysis is bulky and
expensive, primarily because of the large quantity of dialysing
fluid and the handling of blood. In both types the patient must be
attached to the equipment and remains essentially immobilized for
the duration of the dialysis process. The complexity and high risks
associated with currently used dialysis equipment and methods have
resulted in the administration of treatments as infrequently as
possible, usually about 2-3 times weekly. In the time period
between treatments the concentration of metabolic wastes in the
patient's blood stream continuously increases reaching levels which
normally cause discomfort and often debilitation prior to the next
dialysis treatment.
The discomfort and incapacity prior and during treatments often
impairs the patient's ability to lead a normal, productive life and
may also lead to serious psychological problems.
OBJECTS AND SUMMARY OF THE INVENTION
It is a general object of the present invention to provide a
steady-flow regenerative peritoneal dialysis system and method
which overcomes a number of the drawbacks of presently used systems
and methods.
It is another object of the present invention to provide a
peritoneal dialysis system and method which employs a small amount
of dialysate fluid which is circulated at low, steady flow rates
through the peritoneal cavity via in-flow and out-flow tubes
extending through the abdominal wall.
It is another object of the present invention to provide a
regenerative peritoneal dialysis system and method wherein the
fluid employed is regenerated and the amount retained in the
abdomen is minimized whereby the abdominal cavity is not distended
by a large amount of fluid and virtually no discomfort results from
the presence of the fluid within the cavity.
It is a further object of the present invention to provide a
peritoneal dialysis system and method in which the dialysis is
performed at steady flow rates and approaches continuous use
thereby eliminating excessive concentrations or urea and other
metabolic wastes which would otherwise build up in the blood stream
and thereby avoid abrupt changes in waste concentration resulting
from present dialysis processes.
It is a further object of the present invention to provide a
continuous regenerative peritoneal dialysis system and method in
which the in-flow and out-flow tubes extending through the
abdominal wall into the peritoneal cavity are permanently affixed
and are formed whereby the tissue may readily grow to the surface
of the tubes to form a living seal to prevent bacterial
infection.
The foregoing and other objects of the invention are achieved by a
dialysis system including in-flow and out-flow conduits extending
through the abdominal wall and provided with a surface which
permits the growing and attachment of tissue to the surface of the
conduits. The conduits provide means for introducing and removing
fluid from the peritoneal cavity which communicates with means for
circulating the dialysate fluid through the cavity and regenerative
means for regenerating the fluid. The cavity, associated conduits,
and circulating and regenerating means are connected in a closed
fluid system whereby the fluid is continuously reconstituted and
circulated through the peritoneal cavity.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic diagram of the regenerative peritoneal
dialysis system in accordance with the present invention shown
connected to supply fluid to the cavity.
FIG. 2 is an enlarged view of the abdominal wall showing the skin,
subcutaneous tissue and peritoneum together with a conduit anchored
in the wall by tissue growth.
FIG. 3 is an enlarged view of the portion of the conduit of FIG. 2
showing the surface microcavities into which the tissue grows.
FIG. 4 is a detailed drawing of the fluid circulating flow control
and regeneration means.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
In accordance with one feature of the invention, two substantially
identical permanent percutaneous tubes 11 and 12 are inserted
through the abdominal wall. One tube, tube 12, is shown in enlarged
view in FIG. 2. The tube may be formed of silicone rubber material
with an outer wall containing a plurality of irregular
microcavities 13. These microcavities may be formed in accordance
with the method set forth in copending application Ser. No. 77,289
filed Oct. 1, 1970 to provide microcavities which have a depth in
the range of 0.002 to 0.020 inches. These microcavities permit the
subcutaneous tissue to grow around the outside walls and become
permanently affixed or anchored to the walls. Thus, the track along
the peritoneal penetrations is completely sealed by the tissue
which grows into the microcavities and is nourished from adjacent
cells.
The tubes are preferably very small in diameter, for example, 1 to
3 mm. in diameter, and are very flexible because of the very low
flow rates required in steady flow dialysis in accordance with
another feature of the present invention. Both of these
characteristics greatly facilitate the permanent fixation of the
tubes into the abdominal wall. The conduits 11 and 12 each have a
portion 16 and 17, respectively, which extend into the abdominal
cavity. The other end of the conduit 12 is connected to means for
removing the fluid from the abdominal cavity comprises a conduit 18
which, in turn, connects the pump 19 which serves to transport
fluid from the upper portion of the abdominal cavity and pumps the
fluid along the conduit 21 to the reconstitution system 22 which
reconstitutes the dialysate fluid and forms a means for supplying
the fluid to the abdominal cavity. The fluid then flows through the
conduit 23 through the conduit 11 and into the lower portion of the
abdominal cavity at the tube 16. Thus, it is seen that there is
formed a closed system in which the dialysate fluid is circulated
and reconstituted.
The out-flow from the peritoneal cavity flows along the line 18 to
the fluid pump 19. The pump 19 may include a cup-shaped chamber 26
provided with a cap 27 which is suitably secured to the portion 26
as, for example, by screws. Piston 28 which includes a pair of
spaced ports 29 provided with one-way valves 31 is disposed in the
chamber 26. The piston is urged in one direction by means of a pair
of springs 32 which are suitably secured between the piston 28 and
the bottom wall of the cup and serve to urge the piston in said one
direction to draw fluid from the cavity into the chamber 33.
Chamber 33 is defined by the walls of the cup-shaped chamber 26 and
the flexible membrane 34 which may have one end suitably secured to
the piston as by a ring 36 and its other end suitably secured to
the cup by being sandwiched between the cap 27 and the side walls
26. Thus, fluid is drawn into the chamber 33 as the springs urge
the piston in one direction. At the same time as fluid is being
drawn into chamber 33, the fluid in the upper chamber 39, which is
defined by the other side of the piston, the flexible seal membrane
34 and a second sealing membrane 40, is moved through the conduit
21 into the reconstitution system. The upper chamber 39 is defined
by the upper wall of the pump together with the flexible seal 36
which has one end affixed to the upper wall by means of a ring 41
and to the piston rod by means of a second ring 42.
The reconstitution system may be one of two general types. In a
first type, illustrated in FIGS. 1 and 4, the fluid travelling
along the conduit 21 passes through a urea removal column 46, an
activated carbon or charcoal column 47, a transparent conduit
portion 48 which is irradiated by an ultra-violet source 49, and a
conventional flow regulator 50 which regulates the flow and finally
through a filter 51. The reconstituted fluid leaving the
reconstitution system is then applied along the conduit 23 to the
in-flow conduit 11. The rate of flow through the system is
controlled by flow regulator 50.
After the piston P reaches the top of the stroke, the chamber 33 is
full and, of course, chamber 39 is basically empty. The piston is
then depressed and fluid is transferred from the lower chamber 33
to the upper chamber 34, through valve means 31. When the piston
reaches its lowest stroke, the piston is released and the springs
urge the piston upwardly pumping fluid into the chamber and
expelling fluid from the chamber 39.
Although rolling diaphragms or seals are indicated and are
preferable since there is minimal leakage and a reliable method of
knowing the piston displacement and rate and minimal friction, it
is, of course, apparent that other seals such as O-ring seals or
the like could be employed. In any event, the pump is entirely
sealed and remains sterile.
The urea removal column includes material which serves to absorb
urea or converts the urea to ammonia enzymatically as with the
enzyme, urease, and then absorbs the ammonia. Such columns are
known.
An activated carbon column may be used to absorb creatinine, uric
acid and other toxic substances. The ultraviolet sterilizer is used
to sterilize the dialysate and prevent bacterial growth. The filter
may be of a type which can or cannot pass bacteria depending upon
the effectiveness of the ultra-violet sterilizer and sterilizing
procedures. It, of course, will trap larger particles and prevent
them from entering into the abdominal cavity where they may be a
source of tissue irritation and adhesions. The filter, flow
regulator, sterilizer, transparent window and reconstitution
columns form a self-contained package which may or may not include
the pump and which can easily be replaced. The fact that a very
small amount of dialysate is used, of the order of one liter or
less, and the fact that this same amount of dialysate is
continuously reconstituted permits use of a steady flow and
possibly a continuous dialysis process. Further, the system is of
relatively small size because of the small volume of dialysate
fluid being used which makes it possible to devise a system which
can be made portable and worn in the vicinity of the patient's
waist. Thus, the patient can be completely rehabilitated by wearing
such a system. He can continue to perform his normal tasks while
dialysis is taking place. This is very much like a physiologic
process performed by the kidneys.
In a second type of reconstitution system, not shown, which is
conventional in the dialysis field, essentially all of the material
removed from the abdominal cavity is non-selectively eliminated
from the dialysate fluid. Those components removed during dialysis
which are desirable to replace, such as glucose, the ions of
sodium, calcium and potassium are supplied to the in-flow conduit
from a source external to the reconstitution system. Such systems
include the electrolytic type as described in S. B. Tuwiner,
"Research Design and Development of an Improved Water Reclamation
System for Manned Space Vehicles" (April 1966), Report No. NASA
CR66323, and the ion exchange type as described in R. D. Fall et
al., "Feasibility of Microcapsule System for Artifical Kidney
Applications," Annual Report by Battelle Memorial Institute (Dec.
1968).
A simplified technique for supplying dialysate fluid to the
abdominal cavity and removing the fluid from the same eliminates
the need for any reconstitution system. In this technique the
dialysate fluid is supplied from a fresh external source along with
the aforementioned desirable components removed during dialysis.
The fluid removed from the abdominal cavity is directed to a waste
sink.
In summary, the features that make this system possible and of
considerable advantage over prior art systems are the use of the
permanently implanted conduits which allow fluid to be introduced
and removed from the peritoneal cavity, the reconstitution system
which permits the same fluid to be recycled after the waste that is
picked up in the peritoneal cavity has been removed, and the simple
system for sterilizing and pumping the fluid through the
regeneration system and back to the abdominal cavity.
The use of small amounts of fluid which are recycled has added
advantages. Many of the abnormal side effects resulting from either
hemodialysis or peritoneal dialysis with large volumes of fluid are
avoided since this same fluid can be saturated with all those
constituents which are normally depleted from the blood stream when
a large amount of dialysate is used. Low flow rate also permits
effective ultra-violet sterilization and ultrafiltration to be
accomplished.
* * * * *