U.S. patent number 3,640,269 [Application Number 04/869,170] was granted by the patent office on 1972-02-08 for fluid-conducting instrument insertable in living organisms.
Invention is credited to Jose M. R. Delgado.
United States Patent |
3,640,269 |
Delgado |
February 8, 1972 |
FLUID-CONDUCTING INSTRUMENT INSERTABLE IN LIVING ORGANISMS
Abstract
An instrument for insertion in living organisms, having two
flexible fluid-impermeable tubes open at one end and provided at
the other end with enlarged bag formations which are self-sealing
after being punctured with a needle, and a porous bag closed except
for an open end with which the open tube ends communicate, with the
latter being received in and attached to the open bag end and
sealed from the outside of the bag.
Inventors: |
Delgado; Jose M. R. (New Haven,
CT) |
Family
ID: |
25353058 |
Appl.
No.: |
04/869,170 |
Filed: |
October 24, 1969 |
Current U.S.
Class: |
600/573;
604/93.01; 604/175; 600/582 |
Current CPC
Class: |
A61M
39/0208 (20130101); A61M 2039/0211 (20130101) |
Current International
Class: |
A61M
39/02 (20060101); A61b 005/00 () |
Field of
Search: |
;128/2,2.05,2.1,213,214,260,261,348-351,240-241,239 ;424/16,19
;3/1 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Truluck; Dalton L.
Claims
I claim:
1. An instrument insertable into living organisms, comprising two
flexible fluid-impermeable tubes of the same uniform
cross-sectional size, with said tubes being open at one end and
provided at their other ends with enlarged flexible
fluid-impermeable bag formations which are puncturable with a
hypodermic needle and self-sealing on needle retractions; and a
separate elongated porous bag having an open end and being
otherwise closed, and receiving in its open end side-by-side
disposed endlengths of said tubes including said open ends thereof,
and said tube endlengths being attached to said open bag end and
sealed from the outside of said bag, with other endlengths of said
tubes including said bag formations being unattached to each other,
and said porous bag defining a counterflow path from either of said
open tube ends to the other open tube end.
2. An instrument as in claim 1, in which said bag formations are of
substantially the same volume.
3. An instrument as in claim 1, in which said tubes are unattached
to each other except at their attachment to said open bag end.
4. An instrument as in claim 1, in which said endlengths of said
tubes received in said open bag end are of the same length.
5. An instrument as in claim 1, in which the pores of said porous
bag are of a size below 0.5 microns.
Description
This invention relates to medical instruments in general, and to
instruments for passing fluids into and from living organisms in
particular.
The present invention is concerned with instruments that are
insertable or implantable in living organisms for passing fluids
therefrom and/or thereinto for medical-scientific and therapeutic
purposes. Prior instruments of this type are known, but these are
mostly in the form of needles or cannulae which, while serving for
highly useful purposes, are limited in their applications.
Particularly lacking among these prior instruments is one single
instrument which readily lends itself to any of various procedures
involved in medical techniques, such as supplying a liquid medium
to a localized part of a living organism at a prescribed rate over
a desired, including relatively long, time span with or without
human supervision, extracting matter in liquid form from a
localized part of a living organism, and circulating liquid medium
through a localized part of a living organism for any desired
length of time. Further, in using prior instruments of this type in
living organisms, there is always the risk of introducing
micro-organisms into, and thus contaminating, these organisms.
It is among the objects of the present invention to provide an
instrument of this type which not only lends itself readily to any
of the aforementioned various procedures involved in medical
techniques, but the use of which in any part of a living organism
does not involve any risk of introducing micro-organisms into the
organism dealt with.
It is another object of the present invention to provide an
instrument of this type which for insertion in a living organism
includes preferably flexible tubing, and for displacement of fluid
into or from an organism provides the tubing with a closed lead end
and with a porous wall over a length of the tubing near, and
preferably extending to, the closed lead end. With this
arrangement, the inserted instrument with its porous wall in a
desired location in a living organism, may be attended to at its
outer end, either to introduce into the tubing a liquid for its
gradual, dosed, seepage through the porous wall and perfusion of
the organism, or to draw liquid from the organism through the
porous wall into and out of the tubing.
It is a further object of the present invention to provide an
instrument of this type in which the porosity of the aforementioned
wall of the tubing is such that the pores will block the passage of
micro-organisms but will permit the passage of fluids involved in
the various medical procedures.
Another object of the present invention is to provide an instrument
of this type in which the aforementioned lead end and porous wall
of the tubing are formed by a separate porous application bag which
is joined and open to the tubing and is preferably flexible and of
sufficient volume to hold a substantial quantity of liquid. With
this arrangement, the tubing may be of any nonporous material well
tolerated by living tissue, such as stainless steel or Teflon, for
example, while the application bag may be of any suitable porous
material, such as polypropylene sheet of proper pore size, for
example, which may readily be joined to the tubing either directly
or by a binder. Further, the bag may hold liquid, such as a
medicating drug, for instance, in sufficient quantity to perfuse an
affected part of a living organism for a relatively long
period.
A further object of the present invention is to provide an
instrument of this type of which the tubing is in the form of twin
tubes side-by-side at least over their insertable length, and the
aforementioned porous application bag is joined and open to both
tubes. With this arrangement, charging the bag of the inserted
instrument with a liquid is expedited as well as facilitated, in
that the liquid may be introduced through one tube while the bag is
vented through the other tube. Further, the inserted instrument
lends itself to the additional procedure of circulating a liquid
for any length of time through the affected area within an organism
without possible contamination of the latter by micro-organisms.
This is achieved by connecting the outer ends of the tube with the
outlet and inlet of a pump so as to form through the tubes and bag
a circulatory passage via the pump and keep this passage filled
with liquid. With the liquid in this circulatory passage being then
subjected to the positive and negative pressure from the operating
pump, the liquid is displaced from the application bag into the
organism and back from the organism into the bag. The inserted
instrument also lends itself still further to electric stimulation
of, and recording from, a living organism, such as the brain, for
example, by introducing through the tubing an insulated conductor
with its bare conductive tip extending into the application bag,
and filling the bag with an electrolite, such as spinal fluid,
which by its perfusion of the cerebral tissue around the bag
establishes electrical contact between the tissue and
conductor.
It is another object of the present invention to provide an
instrument of this type of which the outer ends of the twin tubes
are closed, and are preferably formed as enlarged reservoir bags of
a material which allows repeated puncturing with a needle without
giving rise to leakage after retraction of the needle. With this
arrangement, the instrument lends itself particularly well, though
not exclusively, to implantation, with the reservoir bags being
arranged subcutaneously but readily accessible with needles through
the skin overlying these bags, so that the instrument lends itself
to any and all of the aforementioned procedures. Further, with the
entire instrument closed except for the pores in the application
bag, the rate of seepage of a liquid from the application bag into
a living organism, or vice versa, may be varied considerably by
superatmospheric or subatmospheric air or gas pressure applied to
the closed instrument through a needle into either of the reservoir
bags.
Further objects and advantages will appear to those skilled in the
art from the following, considered in conjunction with the
accompanying drawings.
In the accompanying drawings, in which certain modes of carrying
out the present invention are shown for illustrative purposes:
FIG. 1 is a section through an instrument embodying the present
invention, with the instrument shown in this instance implanted in
a living organism;
FIG. 2 is a section through an instrument embodying the invention
in a modified manner; and
FIG. 3 is a fragmentary enlarged view of a prominent part of either
instrument of FIG. 1 or FIG. 2.
Referring to the drawings, and more particularly to FIG. 1 thereof,
the reference numeral 10 designates an instrument which is
insertable into living organisms for passing fluids therefrom
and/or thereinto for medical-scientific and therapeutic purposes.
The present instrument is shown in this instance inserted, and more
particularly implanted, in a living brain B beneath a skull S. The
instrument is adapted for injecting into, or retracting from, a
living organism fluid, and more particularly various liquids. To
this end, the instrument has as its major components
fluid-conducting tubing 12 and an application bag 14 at the inner
end 16 of the tubing 12. The tubing 12 consists of a plurality of
tubes 18, two in this instance, which are of a material that is
impermeable to fluids and well tolerated by the tissue, such as
Teflon or some other suitable plastic, or stainless steel. Some of
these materials lend flexibility to various desired degrees to the
tubes.
The application bag 14, which is preferably a separate part, is in
this instance elongated and is closed at its lead-in end 20 and
open at its other end 22. The tubes 18 project with their open ends
16 into the open end 22 of the bag 14 and are there suitably
attached to each other so that the tubes and bag are sealed from
the outside of the bag. In accordance with an important aspect of
the invention, the application bag 14 is porous for the
displacement of fluid, and especially liquids, thereinto and
therefrom. The bag 14 may be formed of any suitable porous
material, such as polypropylene, polysulfone or cellulose acetate,
for example. The tube ends 16 may be attached to each other and to
the surrounding bag end 22 by any known method of bonding plastic
to plastic or stainless steel, depending on the materials used. The
remainder of the tubes 18 are preferably unattached to each other
so that they may be separated, for example to diverge with their
outer ends 24 in the fashion shown in FIG. 1.
The outer ends 24 of the tubes 18 may be open for injection or
retraction of fluid into or from the tubes. Preferably and
advantageously, however, the outer ends 24 of the tubes 18 are
formed as closed reservoirs in the form of bags 26 which may be
formed integrally with, or suitably joined to, the respective tubes
18. These bags 26 are of any suitable material which allows
repeated puncturing with a needle 28 and self-seals after each
needle retraction. Among such suitable materials is silicone
rubber, for example.
While dimensions of the tubes 18, application bag 14 and reservoir
bags 26 may obviously vary for applications of the instrument to
different living organisms, there are given, by way of example
only, the dimensions of a specific instrument actually implanted in
a living brain as shown. Thus, each of the tubes 18 had an outer
diameter of about 0.9 mm., the application bag 14 measured about
1.8 mm. in diameter and about 5 mm. in length, while each of the
reservoir bags measured about 5 mm. in width w and about 10 mm. in
diameter. The instrument was implanted in the brain B by
conventional surgical procedure, with the tubes 18 being secured in
the drilled hole h in the skull S with a suitable cement c, in this
instance acrylic cement, and the reservoir bags 26 being in this
instance placed subcutaneously, i.e., below the scalp s, as shown,
and anchored to the skull S as by the vitallium screws (not shown).
In introducing the instrument in the brain, the application bag 14
was directed to the desired location and also depth in the brain
with the aid of a fine metallic introductor directed by the
micromanipulator of a stereotaxic instrument.
The instrument thus implanted in the exemplary brain B can be used
for various purposes. One of these purposes is intracerebral
injection of a drug solution. To this end, the needle 28 of a
charged syringe 32 is entered through the scalp s into the
subcutaneous bag 26a, for example, whereupon the plunger of the
syringe is driven forward to eject the drug charge into the bag 26a
while the instrument is being simultaneously vented at the other
subcutaneous bag 26 through a needle 28 of another syringe 34 (FIG.
1). Drug solution of any desired amount may thus be introduced in
the instrument. This drug solution will then enter the brain area
around the application bag 14 at a readily controlled volumetric
rate. Control over the rate of displacement of the solution from
the application bag 14 is achieved by the pores p in this bag (FIG.
3) which lend it the desired porosity, by the total volume of drug
solution injected into the instrument, by the selective pressure
within the instrument, and by the concentration of the drug
solution. The particular application bag used in the aforementioned
specific instrument had a pore size below 0.2 microns and water
permeability above 60 ml./min./cm..sup.2, but these data are given
only by way of example and not limitation. Insofar as the pressure
within the instrument is concerned, this may be regulated anywhere
from the subatmospheric to superatmospheric by proper manipulation
of the syringes 32 and 34, as will be readily understood. Further,
the higher the concentration of the drug solution, the more rapid
will be its displacement from the application bag 14 into the brain
regardless of the pressure of the instrument. Thus, even if there
is no pressure on the solution in the instrument, i.e., if the
pressure therein is approximately atmospheric, the solution will
pass from the porous bag 14 into the brain at a rate depending on
its concentration. It is thus readily apparent that by means of the
present instrument a drug solution may perfuse the brain at a rate
and over a time span within relatively wide limits.
The exemplary instrument may serve for numerous other purposes.
Thus, it may serve for intracerebral collection. To this end, the
instrument is filled with a suitable solution, such as synthetic
spinal fluid, for example, and a negative pressure is maintained in
the instrument by injecting slowly and placing the collecting
syringe below the level of the head, with the negative pressure
being proportional to the diameter of the needle used and to the
differential levels between the injection and collection
syringes.
Another application of the instrument is for recirculation of a
fluid. To this end, a pump is interposed between the applied
syringes to complete a recirculation path through the instrument,
with the collected fluid being reintroduced into the subcutaneous
injection bag and recirculated intracerebrally for as long as
desired. In this application, for example, neurochemical
equilibrium between brain and perfused fluids may be established
within a certain period of time, increasing the concentration of
neurohumors released from the brain into the synthetic spinal
fluid.
Still another exemplary application of the instrument is for
electrical stimulation and recording. To this end, one of the
subcutaneous bags is punctured with a fine needle, whereupon an
insulated Teflon-coated stainless steel wire with a bare conductive
tip is through the needle introduced as a stylet to establish
electric contact with the cerebral tissues around the application
bag through intermediation of an electrolite, such as spinal fluid,
in the instrument.
In all of these and still other applications, no micro-organisms
may enter the living organ because the pore size of the porous
application bag is in any event such as to block the passage of
organisms. Pore sizes of below 0.5 microns are recommended to that
end.
With the instrument implanted as in the example shown, the same is
ready for use at any time, but during periods of rest there is no
instrumentation breaking the continuity of the skin.
Short or long term intracerebral injections will have important
scientific and therapeutic applications. Following are a few
exemplary ones of these applications:
a. to increase the dopamine content of the pallidum in patients
with Parkinson's disease,
b. to inhibit the abnormal functioning of localized areas of the
brain by slow, chronic infiltration with blocking agents,
c. to administer antiepileptic medication to the site of the origin
of disturbed electrical activity in patients with epilepsy, and
d. electrical stimulations and recordings which may provide basic
information for diagnostic and therapeutic purposes. In addition,
analysis of chemicals released locally by the brain may orient the
diagnosis of cerebral disturbances and may guide the administration
of drugs.
While the instrument is shown implanted in a brain in the example
shown in FIG. 1, it may, of course, be implanted, or merely
inserted, in any other living organism with or without requiring
surgery for its introduction into the organism.
Reference is now had to FIG. 2 which shows a modified instrument
10a that is like the described instrument 10 of FIG. 1, except that
there is only one tube 18a and one outer bag 26b. The application
bag 14a is porous, the same as the bag 14 of the instrument 10. The
present instrument 10a lends itself to similar applications as the
instrument 10, though with obvious limitations owing to the single
tube 18a and single outer bag 26b.
* * * * *