U.S. patent number 3,888,239 [Application Number 05/481,501] was granted by the patent office on 1975-06-10 for fluid injection system.
Invention is credited to Morton K. Rubinstein.
United States Patent |
3,888,239 |
Rubinstein |
June 10, 1975 |
Fluid injection system
Abstract
An injection system that eliminates the need for multiple
syringe changes common to an angiographic or other catheterization
procedure, is disclosed. The subject system includes a pair of
reservoirs for respectively maintaining saline solution and
contrast dye under pressure for controlled injection into a
patient. The reservoirs are maintained full by automatically
filled, after a predetermined time delay, whenever any amount is
used. Peristaltic pumps connected to supplies of saline solution
and contrast dye function to fill and refill the reservoirs.
Inventors: |
Rubinstein; Morton K. (Los
Angeles, CA) |
Family
ID: |
23912172 |
Appl.
No.: |
05/481,501 |
Filed: |
June 21, 1974 |
Current U.S.
Class: |
600/432; 604/135;
604/153; 604/123; 604/191 |
Current CPC
Class: |
A61M
5/14216 (20130101); A61B 6/504 (20130101); A61B
6/481 (20130101) |
Current International
Class: |
A61B
6/00 (20060101); A61M 5/142 (20060101); A61b
006/00 () |
Field of
Search: |
;128/2A,2R,2.5D,214R,214E,214F,214Z,227,229,230,218R,218A,218G,215 |
References Cited
[Referenced By]
U.S. Patent Documents
Other References
Hector - Brit. Jour. Radiology, 44, pp. 892-894, 1971
(Nov.)..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Chung; Eric T. S.
Claims
What is claimed is:
1. An angio-graphic injection system for continuously providing to
a catheter supplies of two separate fluids used in the performance
of a catheterization procedure, the injection system
comprising:
a pair of reservoir means for containing a ready supply of said two
fluids, respectively;
a pair of pressurizing means each connected to one of said pair of
reservoir means for maintaining said fluids contained therein under
a predetermined pressure;
a pair of pumping means respectively connected to one of said
reservoir means for pumping fluid into said reservoir means from a
source thereof to continuously maintain said reservoir means in a
filled condition;
and fluid conduit means for interconnecting said respective
reservoir means and pump means, said fluid conduit means provided
with means for being connected to a catheter to supply said fluids
thereto.
2. The injection system defined by claim 1, further including a
pair of pump actuating means each connected to be respectively
responsive to a different one of said reservoir means being in an
unfilled condition for causing a pumping means to be energized to
pump fluid to said reservoir means until obtaining a filled
condition.
3. The injection system defined by claim 2, said pump actuating
means including time delay means for delaying energization of said
pumping means by a predetermined period of time following said
reservoir means having an unfilled condition.
4. The injection system defined by claim 1, further including
vacuum means adapted to be connected to a container for receiving
waste fluids for reducing the interior pressure of said
container.
5. The injection system defined by claim 1, further including valve
control means connected to said pair of reservoir means for
controlling the withdrawal of said fluids from both said reservoir
means.
6. The injection system defined by claim 1, said pair of reservoir
means each including:
a housing defining an interior cavity;
a plunger adapted to be inserted into and retracted from said
interior cavity; and
inlet means extending through said housing into said cavity whereby
said fluid is injected into and ejected from said interior cavity
through said inlet means.
7. The injection system defined by claim 1, said pair of reservoir
means each including a syringe having an inlet needle thereof
connected to have fluid ejected therethrough and pumped
therethrough by said pumping means.
8. The injection system defined by claim 1, said pair of pumping
means each including a peristaltic pump.
9. The injection system defined by claim 1, said pair of
pressurizing means each including spring biased means for applying
a mechanical force to said reservoir means corresponding thereto to
have fluid contained by said reservoir means maintained at a
predetermined pressure in said reservoir.
10. The injection system defined by claim 9, said spring biased
means including:
a telescoping member;
a spring positioned to apply a mechanical force to said telescoping
member; and means for adjustably compressing said spring
to adjust said mechanical force applied to said telescoping member
in accordance with said determined pressure.
11. The injection system defined by claim 2, each of said pump
actuating means including:
switching means responsive to a corresponding one of said reservoir
means being in an unfilled condition for causing electrical energy
to be applied to a corresponding one of said pumping means; and
time delay means connected to said switching means for delaying
energization of said pumping means by a predetermined period of
time following said reservoir means having an unfilled
condition.
12. The injection system defined by claim 6, said pair of
pressurizing means each including spring biased means for applying
a force to said plunger at a corresponding one of said reservoir
means to have fluid contained in said interior cavity maintained at
a predetermined pressure.
13. The injection system defined by claim 12, said spring biased
means including:
a telescoping member;
a spring positioned to apply a mechanical force to said telescoping
member; and
means for adjustably compressing said spring to adjust said
mechanical force applied to said telescoping member in accordance
with said determined pressure.
14. The injection system defined by claim 13, further including a
pair of pump actuating means each connected to be respectively
responsive to a different one of said reservoir means being in an
unfilled condition for causing a pumping means to be energized to
pump fluid to said reservoir means until obtaining a filled
condition.
15. The injection system defined by claim 14, each of said pump
actuating means including:
switching means responsive to a corresponding one of said reservoir
means being in an unfilled condition for causing electrical energy
to be applied to a corresponding one of said pumping means; and
time delay means connected to said switching means for delaying
energization of said pumping means by a predetermined period of
time following said reservoir means having an unfilled
condition.
16. The injection system defined by claim 15, further including
valve control means connected to said pair of reservoir means for
controlling the withdrawal of said fluids from both said reservoir
means.
17. The injection system defined by claim 16, further including
vacuum means adapted to be connected to a container for receiving
waste fluids for reducing the interior pressure of said
container.
18. The injection system defined by claim 17, said pair of pumping
means each including a peristaltic pump.
19. The injection system defined by claim 6 further including
indicator means for providing an indication of the volume of each
dose of fluid ejected from said reservoir means, said indicator
means being positioned to respond to movement of said plunger of
said reservoir means.
20. The injection system defined by claim 6, further including
mounting means for removably securing each of said reservoir means
whereby said reservoir means are each adapted to be removable and
disposable.
21. The injection system defined by claim 18, said two fluids
including saline solution and radio-opaque dyes.
Description
BACKGROUND OF THE INVENTION
1. Field of the Invention
This invention generally relates to medical equipment useful in
performing an angiographic or other catheterization procedure. More
specifically, the present invention concerns a fluid injection
system that is designed for use in carrying out an angiographic
procedure or other catheterization.
2. Description of the Prior Art
Recent advances in medical science have included the development
and refinement of diagnostic X-ray techniques. Angiography or
arteriography is one of such diagnostic X-ray techniques.
Generally, angiography involves the injection of radio-opaque dye
or contrast dye into an artery or arteries of a human body under
examination. When X-rays are thereafter taken, a shadow is produced
by the dye on the X-ray pictures and thereby provides an outline of
the arteries in which the dye has been injected. The shadow is due
to the X-rays passing through the normal body tissues but not the
dye.
Angiography thus allows physicians and other medical diagnosticians
to study almost any part of the body as well as the blood vessels
and specific organs in a human body. As an example, injection of
radio-opaque dye into blood vessels will indicate the presence of
obstructions, blockages, or constriction of the arteries. Also
identifiable would be displacement of the arteries. Such
information is essential in completely studying patients to
determine the presence or absence of brain tumors, blood clots, and
other abnormalities, and the need for corrective surgery or the
like. As a further example, angiography is useful for examining
patients that may be suffering from heart disease to determine the
existence of blocked or partially obstructed coronary arteries as
may be present in connection with an angina condition or following
a heart attack.
Contrast dye can also be injected directly into the heart to
determine the existence of leaky valves. The basic angiographic
procedure is also adapted for use in obtaining pressure
measurements as is useful in diagnosing leaky heart valves.
Typically, an angiographic procedure involves directly inserting a
catheter into one of the blood vessels of the body. The major
artery in the groin is frequently chosen, although other arteries
may also be used. A needle may be first inserted into the artery
and a catheter then threaded through the hollow of the needle into
the artery. The needle can then be removed. Once inserted into the
artery, the catheter is then slowly threaded through the artery to
have the tip thereof become situated in the area of the body or
within the organ to be examined.
It is necessary that the location of the catheter be known at all
times. To this end, small amounts of contrast dye are introduced at
frequent intervals through the catheter to have the dye fill the
blood vessel at the tip of the catheter. A fluoroscope may then be
used to provide a specific indication of the whereabouts of the tip
of the catheter within the body as it is threaded into the body
through the artery.
Dye and saline cannot be left in the catheter for too long a period
of time because of the possibility of clot formation. Accordingly,
the catheter must be intermittently rinsed with fresh saline
solution which is injected through the catheter into the body to
wash the dye out of the catheter.
Injection of the dye and saline solutions is presently accomplished
by the use of syringes which are alternately manually connected and
disconnected from the end of the catheter or extensions thereof.
Hence, each injection of contrast dye requires that two separate
syringes be successively attached and detached from the catheter.
In the course of a single angiographic procedure to study parts of
a patien's head or neck, as many as 50 or more syringe changes may
be required.
The withdrawal of blood through the catheter, as may be required
during an angiographic procedure, would require further attachment
and detachment of a syringe or syringes from the catheter.
Culmination of the angiographic procedure occurs when the catheter
is finally worked into the position desired, and a relatively large
volume of contrast dye is quickly injected under high pressure into
the area to be examined. A plurality of X-ray pictures are then
taken in quick succession. As an example, study of the heart
normally involves injection of 40 cc of dye at a pressure of 1,000
psi. Examination of the brain would typically involve the injection
of 8 cc of contrast dye under a pressure of 40 psi. If the X-ray
pictures that are taken are satisfactory, the catheter is either
removed or relocated to another region of the body for study.
Other forms of catheterization would include hystosalpingograms,
retrograde cysternograms and cardiac catheterizations. In each
instance, a catheter is inserted into a blood vessel or other body
cavity for the purpose of injecting fluid into the cavity, taking
pressure measurements, and/or withdrawing blood or other body
fluids.
It is clear that the current techniques for performing an
angiographic procedure are crude, time consuming, and dangerous,
however useful and/or necessary the results may be. Specifically,
the need for numerous syringe connections and disconnections as dye
and saline solution is injected is tedious as well as time
consuming; but perhaps of most importance is the danger presented
by the opportunity for clot formation as a result of exposure to
air in the course of the many syringe changes.
Accordingly, it is an intension of the subject invention to provide
a fluid injection system that completely eliminates any exposure to
air in the course of an angiographic procedure and is highly
sanitary, which eliminates the need for the multiple syringe
connections and disconnections to the catheter, and which permits a
physician or other person to safely and quickly perform
angiographic procedures.
SUMMARY OF THE INVENTION
Briefly described, the present invention involves a fluid injection
system for use in the performance of an angiographic or other
catheterization procedure.
More specifically, the subject invention involves a closed fluid
system that eliminates the need for the numerous syringe changes
that are presently required in the course of an angiographic
procedure and which thereby eliminates exposure to air and the
attendant dangers resulting from the formation of clots. The system
includes a pair of independent, pressurized reservoirs which are
respectively continuously filled, after a nominal time delay, with
contrast dye and saline solution whenever fluid is drawn from a
reservoir. Pumping mechanisms connected to supplies of such fluids
are automatically actuated to refill the respective reservoirs.
Means are included for providing an indication of both total
consumption of the fluids as well as the size of each dose that is
injected. A vacuum pump is used to maintain a waste container at a
negative pressure with respect to body pressure to enable the
extraction of fluid from a patient's body.
The objects and many attendant advantages of the invention will be
more readily appreciated as the same becomes better understood by
reference to the following description which is to be considered in
connection with the accompanying drawings wherein like reference
symbols designate like parts throughout the figures thereof.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1 is a schematic diagram illustrating a perspective view of
the subject invention.
FIG. 2 is a schematic diagram illustrating a partially cut away,
frontal, plan view of a console used in conjunction with an
angiographic injection system in accordance with the subject
invention.
FIG. 3 is a schematic diagram illustrating a partially cut away,
side, plan view of the console shown in FIG. 2.
FIG. 4 is a schematic diagram illustrating an electrical circuit
that is useful in understanding the operation of the subject
invention.
DESCRIPTION OF THE PREFERRED EMBODIMENT
Referring to FIG. 1 of the drawings, an angiographic injection
system in accordance with the present invention includes a console
unit 2 connected to a supply of contrast dye 4 via tubing 6 and a
supply of saline solution 8 via tubing 10. The console 2 is
connected to continuously make available and provide the contrast
dye and the saline solution to a catheter 12 upon demand via a
manually operable valve control 14 and a pair of output tubes 16
and 18, respectively. The console unit 2 is also connected via a
vacuum hose 20 to depressurize or reduce the pressure of a waste
container 22.
It is to be understood that although contrast dye is discussed
herein that any radio-opaque medium suitable for use in an
angiographic procedure can be used with the subject invention.
As earlier explained, an angiographic or other catheterization
procedure requires the catheter 12 to be threaded into a patient's
body via an appropriate artery or other blood vessel. Contrast dye
and saline solution is injected through the catheter 12 at frequent
intervals to continuously locate and observe the position of the
tip thereof. Hence, the manually operated valve control 14 includes
a pair of valve actuators 24 and 26, each of which functions to
open and close a valve to control the flow of dye and saline
solution to the catheter 12 via the console 2. As an example, the
valve actuators 24 and 26 may simply be levers which control a
three port fluid valve which is effectively opened or closed by
turning of the valve actuators 24 and 26 to permit or stop the flow
of fluid to or from the catheter 12. Accordingly, each of the
actuators 24 and 26 may have a forward position for permitting the
injection of fluid through the catheter 12, and a backward position
for extracting a fluid through the catheter 12, and a middle
position in which no flow is permitted. Any of the numerous types
of conventional fluid valves that are available in the prior art
may be employed as the valve control 14 and the valve actuators 24
and 26 thereof. Extracted fluid may be directed through a hose 27
to the waste container 22.
Referring to FIGS. 2 and 3, the console 2 includes a pair of
identical independent pressurized reservoir systems respectively
for the contrast dye provided from the supply 4 and for the saline
solution provided from the supply 8. A first reservoir 28 may be
used for the contrast dye and a second reservoir 30 may be used for
saline solution by being respectively connected to have fluid
supplied thereto from the supplies 4 and 8 by a pair of peristaltic
pumps 32 and 34 through the tubes 6 and 10. Fluid in the reservoirs
28 and 30 are maintained under pressure by a pair of spring
assemblies 36 and 38, respectively.
Considered in greater detail, the reservoirs 28 and 30 may each
essentially take the form of a syringe and accordingly include a
cylindrical housing 40, an inlet-outlet needle 42, and a plunger
44. The capacity of each of the reservoirs may be in the
neighborhood of 20-40 cc; but any other appropriate capacity may be
used. As is well known, retraction of the plunger 44 from within
the housing 40 will cause fluid to be drawn into the interior
cavity of the housing 40. Similarly, forcing fluid into the housing
40 through the needle 42 will cause ejection of the plunger 44.
Conversely, insertion of the plunger 44 into the cavity of the
housing 40 will force fluid contained therein to be ejected through
the needle 42.
An appropriate walled mount 45 may be used to removably support and
retain syringes that are emplaced as reservoirs 28 and 30. As
shown, the mount 45 may simply involve a clip-like fixture that
receives the housing 40 therein and thereby holds the housing 40
stationary. The mounting fixture 45 may, of course, have any other
configuration that would allow insertion and removal of the
syringes that are emplaced as reservoirs in accordance with the
subject invention.
It is to be understood that although a syringe is described for use
as reservoirs 28 and 30, other configurations or similar devices
may be also employed.
Referring to the saline reservoir 30, as an example, fluid is
forced into the reservoir 30 by operation of a peristaltic pump 34
which serves to draw saline solution from the supply 8 via the
tubing 10. As shown, the tubing 10 is wound through the pump 34 and
is connected to the reservoir 30 via a suitable fluid T-joint 46.
The output tubing 18 is also connected to an arm of the T-joint 46.
Operation of the pump 34 will cause saline solution to be pumped
through the T-joint 46 into the reservoir 30 provided that the
output tubing 18 is closed off such as the valve actuator 26. In
the event that the output tubing 18 is opened such as by operation
of the valve actuator 26, the pump 34 will function to pump fluid
through the output tubing 18 and through the catheter 12 assuming
that a stop-cock 48, which may be provided, as shown in FIG. 1, is
opened rather than closed.
The spring assembly 38 operates to maintain fluid contained by the
reservoir 30 under pressure by having a telescopic section 50
thereof positioned against the end of the plunger 44 to urge said
plunger 44 into the housing 40 to thereby eject the fluid therein.
The amount of force or pressure applied to the plunger 44 by the
telescoping section 50 of the spring assembly 38 may be readily
adjusted by operation of an adjustment knob 52 which extends
through an outer casing 54 of the console 2. The adjustment knob 52
is threadably connected to a spring compression plate 56 which
functions to compress a spring 58 as it is driven in a downward
position in FIG. 2 in response to appropriate turning of the knob
52. Increased compression of the springs 58 will, of course,
increase the force applied to the plunger 44 via the telescoping
section 50 and thereby increase the pressure of the fluid contained
by the reservoir 30. The spring assembly 38 may be readily
calibrated in a manner well known to persons skilled in the art to
obtain desired fluid pressures for the contrast dye and saline
solution that are provided from the reservoirs 28 and 30 and as may
be required for the examination of different organs, i.e., 40 psi
for injection of contrast dye into a brain being examined.
The telescoping section 50 may be equipped with an indicator arrow
60 or the like which extends through a slot 62 in the casing 54 to
provide a visual indication, in conjunction with a scale 64, of the
size of each dose of fluid ejected or injected into a patient. To
this end, refilling a reservoir after the ejection of each dose is
nominally delayed, i.e., 5 seconds, to permit a true uninterrupted
dose indication, as is explained hereinbelow.
The indicator arrow 60 would be in a raised position when the
reservoir is filled and would be lowered as the plunger 44 is
driven into the housing 40 by the spring assembly 38 as fluid is
ejected. The scale 64 may involve any appropriate units such as
cubic centimeters (cc) and may be simply painted or etched onto the
casing 54. The indicating arrow 60 may also be mechanically
connected to trigger an audible indicating device as predetermined
amounts of fluid are ejected. For example, a reed comb-type of
device could be used to sound a tone as the indicator arrow 60 is
lowered past individual reeds.
A window 65 may also be provided to allow visual observation of the
contents of each reservoir.
An indication of total consumption of saline solution may be
desired and be provided by an indicator 66 which is connected by a
drive belt 68 to be driven in conjunction with operation of the
peristaltic pump 34. An armature assembly 69 on the pump 34 may be
conveniently used for this purpose. Operation of the pump 34 would
cause the belt 68 to simultaneously drive the indicator 66 in a
conventional fashion. The indicator 66 may be in the form of an
odometer-like device or any other conventional indicator device
well known in the prior art. A similar indicator would be connected
to the pump 32 to indicate total consumption of contrast dye.
As a safety measure, the output tubes 16 and 18 may be connected to
be monitored by a bubble detector 70 of a type well known in the
art. For example, a bubble indicator 70 may simply involve a
photoelectric cell which would be positioned to produce an output
signal whenever illumination directed thereon were to vary, such as
by being increased in response to the passage of an air bubble 70.
The bubble detector 70 would be connected to de-energize the system
such as by automatically opening a switch or the like, as is
explained hereinafter in greater detail.
A vacuum pump 72 may be contained within the casing 54 and have
connected thereto the vacuum hose 20 of which one end is placed in
the closed waste container 22 to reduce the pressure therein,
Depressurizing the container 22 to a pressure that is lower than
body pressure functions to facilitate withdrawal of fluid from a
patient's body. A vacuum gauge 73 may be mounted on the casing 54
of the console 2.
Refilling of the reservoirs 28 and 30 after the withdrawal of any
fluid therefrom is automatically accomplished by having the pumps
32 and 34 respectively connected to be automatically operated
whenever the reservoir is not full. Any convenient switching
arrangement can be used such as by having a wiper arm shown in FIG.
3 serve as a portion of an electrical switch that is closed
whenever the plunger 44 of the reservoir is at any position other
than at a maximum raised position such as is shown for the plunger
44 of the reservoir 30 in FIG. 2. Such electrical switch may simply
involve a contact strip (not shown) that contacts the wiper arm 71
when the plunger 44 is lowered. Clearly the wiper arm 71 can be
appropriately secured to the indicator arrow 60 or to the
telescoping section 50 (as shown) or even to the plunger 44,
although such connection would be less desirable.
Clearly, the subject fluid injection system is a closed fluid
system and hence substantially eliminates the possibility of air
bubbles being introduced into the subject. Further, the subject
system is highly sanitary in that all portions of the system that
are exposed to or come in contact with the saline solution and
contrast dye are disposable and readily replaceable. Specifically,
the disposable items would include the supply bottles 4 and 8,
tubes 6 and 10, reservoirs 28 and 30, T-joints 46, tubes 16 and 18,
and finally valve control 14. The catheter 12 is normally an
expensive item and hence is sterilized for reuse.
Referring to FIG. 4, an electrical circuit for each of the
peristaltic pumps 32 and 34 may include a plug 74 which is adapted
to be connected to any conventional AC power source. Using the pump
34 as an example, the electrical circuit may include a series
connected main power switch 76 which may be in the form of a push
button switch, or a toggle switch, etc., a safety fuse 76, a refill
switch 80, a delay timer 82, and a bubble detector switch 84. The
refill switch 80 would be closed in response to the reservoir 30
not being filled as above discussed and would be opened whenever
the reservoir 30 is filled.
The delay timer 82 would serve to delay energization of the pump 34
and hence delay the filling of the reservoir 30 to permit the dose
indicator 60 to provide an accurate indication before the
corresponding pump commences to refill the reservoir. Any
conventional time delay device may be used to produce the desired
nominal time delay, i.e., four to six seconds, following each
withdrawal of fluid before operation of the pumps 32 and 34. The
time delay is chosen to accommodate the time needed to complete an
injection. The bubble detector switch 84 would normally be closed;
but would be automatically opened in response to detection of an
air bubble by the detector 70.
It is to be understood that the pumps 32 and 34 may be effectively
connected in parallel in a single circuit or in separate circuits
similar to that illustrated by FIG. 4.
The vacuum pump 72 may also be connected to have an electrical
circuit similar to that shown by FIG. 4 or be connected to a common
power buss along with the pumps 32 and 34. However, there would be
no need for any time delay as the vacuum pump 72 may be
continuously operated.
From the foregoing it is now clear that the subject invention
presents a fluid injection system that permits contrast dye and
saline solution to be readily supplied to and injected through a
catheter without the need for the numerous connections and
disconnections that must be manually accomplished in accordance
with present techniques and which thereby eliminates or
substantially reduces the danger of clot formation resulting from
exposure to air, extensive time consumption, and any discomfort
that may be attendant to the conventional need for such syringe
changes.
While a preferred embodiment of the present invention has been
described hereinabove, it is intended that all matter contained in
the above description and shown in the accompanying drawings be
interpreted as illustrative and not in a limiting sense and that
all modifications, constructions and arrangements which fall within
the scope and spirit of the invention may be made.
* * * * *