U.S. patent number 3,920,014 [Application Number 05/475,398] was granted by the patent office on 1975-11-18 for surgical system for controlling the infusion of fluid to and the evacuation of fluid and material from an operating field.
Invention is credited to Anton Banko.
United States Patent |
3,920,014 |
Banko |
November 18, 1975 |
Surgical system for controlling the infusion of fluid to and the
evacuation of fluid and material from an operating field
Abstract
A system for controlling the infusion of fluid to an operating
field at a selected predetermined pressure, as a counterpart to an
instrument for severing material from an object in the field, and
for evacuating the severed material from the field in a suspension
or emulsion of the infusion fluid. The system includes safety
features for preventing a low pressure in the operating field, to
thereby prevent a surge of fluid from the field, and referencing
infusion and evacuation pressures to that of the operating field.
In addition, the basic electrical functions of the entire system
are operated by a single control.
Inventors: |
Banko; Anton (Bronx, NY) |
Family
ID: |
26903062 |
Appl.
No.: |
05/475,398 |
Filed: |
June 3, 1974 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
208282 |
Dec 15, 1971 |
3812855 |
|
|
|
Current U.S.
Class: |
604/31;
604/118 |
Current CPC
Class: |
A61F
9/00763 (20130101); A61M 1/0058 (20130101); A61M
1/79 (20210501) |
Current International
Class: |
A61F
9/007 (20060101); A61M 1/00 (20060101); A61M
001/00 () |
Field of
Search: |
;128/230,276,277,278,2A
;137/205 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Gaudet; Richard A.
Assistant Examiner: Yasko; J.
Attorney, Agent or Firm: Darby & Darby
Parent Case Text
This application is a continuation-in-part of my prior copending
application Ser. No. 208,282, filed Dec. 15, 1971, , now U.S. Pat.
No. 3,812,855 entitled "SYSTEM FOR CONTROLLING FLUID AND SUCTION
PRESSURE" which is assigned to the same assignee.
Claims
What is claimed is:
1. A system for use with a surgical instrument having an operative
part at an operating site comprising:
means for supplying an infusion fluid under pressure to said
operating site,
means for evacuating fluid with other material entrained therein
from said operating site,
means for measuring the pressure of the infusion fluid,
means for measuring the pressure of the evacuated fluid and other
material,
and means responsive to a predetermined measured pressure
difference between the evacuated fluid and the infusion fluid for
terminating the evacuation of fluid from the operating site.
2. A system as in claim 1 further comprising means for visually
displaying the measured pressure of the infusion fluid.
3. A system as in claim 1 further comprising means for visually
displaying the measured pressure of the evacuation fluid.
4. A system as in claim 1 further comprising means for setting said
predetermined pressure at which the evacuation of the fluid from
the operating site is terminated.
5. A system as in claim 1 wherein said means for supplying said
infusion fluid to and said means for evacuating fluid from said
operating site include a portion of said instrument at the
operating site.
6. A system as in claim 1 wherein said means for evacuating fluid
from the operating site includes a peristaltic pump.
7. A system for use with a surgical instrument having an operative
portion at an operating site comprising:
means including first control means for supplying an infusion fluid
under pressure through said instrument to said operating site,
means for evacuating fluid with material entrained therein from
said operating site through said instrument,
means for selectively operating said first control means to open
and close said control means to thereby permit or stop the supply
of the infusion fluid,
and means including second control means and a portion of said
means for evacuating fluid from the operating site in fluid
communication with said evacuation means to supply a further fluid
through said instrument to said operating site.
8. A system as in claim 7 wherein said instrument includes a motor
for rotating at least a part of said operative portion of said
instrument, means for stopping said motor and operating said first
and second control means to supply siad infusion fluid and said
further fluid to said operating site.
9. A system as in claim 7 wherein said instrument includes a motor
for rotating at least a part of said operative portion of said
instrument, means for rotating said motor in a second direction and
operating said first and second control means to supply only said
further fluid to said operating site.
10. A system as in claim 7 wherein said instrument includes a motor
for rotating at least a part of said operative portion of said
instrument, means for stopping said motor and operating said first
and second control means to supply said infusion fluid and said
further fluid to said operating site.
11. A system as in claim 7 wherein said instrument includes a motor
for rotating at least a part of said operative portion of said
instrument, means for rotating said motor in a second direction and
operating said first and second control means to supply only said
further fluid to said operating site.
12. Apparatus as in claim 7 further comprising means for operating
said first and second control means to selectively:
a. open said first and second control means to permit the supply of
both said infusion fluid and said further fluid to said operating
site,
b. to open only said first control means to permit only the supply
of infusion fluid to said site, or
c. to open only said second control means to permit only the supply
of the further fluid to said site.
13. Apparatus as in claim 12 further comprising a reversible motor
for a part of the operative portion of said instrument, said
operating means includes means for
a. stopping said motor when both said first and second control
means are open,
b. rotating said motor in a first direction when only said first
control means is open, and
c. rotating said motor in a second direction when only said second
control means is open.
14. A system for use with a surgical instrument having an operative
part at an operating site comprising:
means for supplying an infusion fluid under pressure to said
operating site,
means for evacuating fluid with other material entrained therein
from said operating site,
means for measuring the pressure of the infusion
means for measuring the pressure of the evacuated fluid and other
material,
and means for referencing the pressures measured to the pressure at
the operating site.
15. A system as in claim 14 further comprising
means responsive to a predetermined measured pressure difference
between the evacuated fluid and the infusion fluid for terminating
the evacuation of fluid from the operating site.
16. A system as in claim 15 wherein said means for evacuating fluid
from the operating site includes a peristaltic pump.
17. A system for use with a surgical instrument having an operative
portion at an operating site comprising:
means including first control means for supplying an infusion fluid
under pressure through said instrument to said operating site,
means for measuring the pressure of said infusion fluid,
means for evacuating fluid with material entrained therein from
said operating site through said instrument,
means for measuring the pressure of the evacuated fluid,
and means for selectively operating said first control means to
open and close said control means to thereby permit or stop the
supply of the infusion fluid.
18. A system as in claim 17 wherein said instrument includes a
motor for rotating at least a part of said operative portion of
said instrument, means for controlling the rotation of said motor
in a first direction with said first control means open to permit
the infusion fluid to be supplied to the operating site.
19. Apparatus as in claim 17 further comprising means including
second control means and a portion of said means for evacuating
fluid from the operating site in fluid communication with said
evacuation means to supply a further fluid through said instrument
to said operating site.
20. Apparatus as in claim 19 further comprising means for operating
said first and second control means to selectively:
a. open said first and second control means to permit the supply of
both said infusion fluid and said further fluid to said operating
site,
b. to open only said first control means to permit only the supply
of infusion fluid to said site, or
c. to open only said second control means to permit only the supply
of the further fluid to said site.
21. Apparatus as in claim 9 further comprising a reversible motor
for a part of the operative portion of said instrument, said
operating means includes means for:
a. stopping said motor when both said first and second control
means are open,
b. rotating said motor in a first direction when only said first
control means is open, and
c. rotating said motor in a second direction wherein only said
second control means is open.
22. A system for use with a surgical instrument having an operative
part at an operating site comprising:
means for supplying an infusion fluid under pressure to said
operating site,
means for evacuating fluid with other material entrained therein
from said operating site,
means for measuring the pressure of the evacuated fluid and other
material,
and means responsive to a predetermined measured pressure for
terminating the evacuation of fluid from the operating site.
23. Apparatus as in claim 22 further comprising means for setting
the predetermined measured pressure at which the evacuation is
stopped.
24. A system for use with a surgical instrument having an operative
part at an operating site comprising:
means for supplying an infusion fluid under pressure to said
operating site,
means for evacuating fluid with other material entrained therein
from said operating site,
means for measuring the pressure of the evacuated fluid and other
material,
means responsive to a predetermined measured pressure for
terminating the evacuation of fluid from the operating site,
and
means for building up the pressure in said means for evacuation
after the evacuation is terminated.
25. Apparatus as in claim 24 further comprising means for reversing
the flow of fluid and material in said evacuation means.
26. Apparatus as in claim 24 further comprising means for venting
said evacuation to another pressure after the evacuation is
terminated.
27. Apparatus as in claim 25 wherein the venting takes place at
atmosphereic pressure.
28. A system for use with a surgical instrument having an operative
portion at an operating site comprising:
means including first control means for supplying an infusion fluid
under pressure through said instrument to said operating site,
means for evacuating fluid with material entrained therein from
said operating site through said instrument,
means for selectively operating said first control means to open
and close said control means to thereby permit or stop the supply
of the infusion fluid,
a motor for rotating at least a part of said operative portion of
said instrument,
and means for controlling the rotation of said motor in a first
direction with said first control means open to permit the infusion
fluid to be supplied to the operating site.
29. A system for use with a surgical instrument having an operative
portion at an operating site comprising:
means including first control means for supplying an infusion fluid
under pressure through said instrument to said operating site,
means for evacuating fluid with material entrained therein from
said operating site through said instrument,
means for selectively operating said first control means to open
and close said control means to thereby permit or stop the supply
of the infusion fluid,
means for measuring the pressure of the infusion fluid,
means for measuring the pressure of the evacuated fluid and other
material,
and means responsive to a predetermined measured pressure
difference between the evacuated fluid and the infusion fluid for
terminating the evacuation of fluid from the operating site.
Description
This invention relates to a surgical apparatus and more
particularly to an apparatus having particular utility in an
operation taking place in a closed operating field, such as the eye
of an animal or human being.
In my aforesaid prior application, a system is disclosed for use in
conjunction with a surgical instrument of the type which can remove
material from an object, such as by cutting, drilling, emulsifying
such as by using ultrasonic energy, tearing, etc. The system
operates to infuse fluid in an operating field for certain
purposes, such as to maintain a predetermined pressure, and also
for evacuating from the field the severed material removed from the
object in suspension with or as an emulsion of the infusion
fluid.
The present invention relates to an improved system of the type
disclosed and claimed in the foregoing application. The system of
the subject invention is capable of performing a variety of
functions all under the control of an operator. Among these are the
supply of a fluid to the operating field at a selected
predetermined pressure after the surgical instrument is inserted to
keep the operating field, for example the eye, formed in its normal
physical shape both before and during the operation. During the
operation the system also: (1) creates an evacuation flow for
transportation of the material severed by the surgical instrument,
which material is suspended or is emulsified in the supplied fluid
and in the normal fluid of the operating field; (2) substitutes
fluid to compensate for the volume of material, both solid and
liquid, removed from the operating field; and (3) maintains the
pressure in the operating field within workable and safe tolerance
levels.
The system also can be operated to generate a reverse flow of fluid
through the instrument into an operative portion thereof when
material being removed inadvertently has entered the instrument and
has to be moved back into the operating field. As a safety feature,
it also builds up a pressure in the evacuation line at or close to
the level of the pressure in the operating field when the
evacuation process has been stopped to substantially prevent
further motion of material from the operating field into the
instrument. This prevents the operating field from being emptied of
material which would ultimately cause it to collapse. In addition,
the system controls the operation of a cutting or emulsifying means
to be either: in a ready condition; in an operative condition
during the conduct of the operation; or, in the case where a
movable cutter is used, to move the cutter in the reverse direction
during the application of fluid in the reverse mode.
It is therefore an object of the present invention to provide a
novel surgical system for controlling the infusion of fluid to an
operating field, the rate of separation or cutting of material from
the object being operated on, and the evacuation of fluid and
material from the operating field.
A further object is to provide a liquid infusion and material
evacuating system for use in connection with a surgical instrument
for removing material from an object.
An additional object is to provide a system utilizing easily
operated control members for controlling the infusion of fluid and
the evacuation of fluid and material from an operating field.
Another object is to provide a liquid infusion and material
evacuating system for use with a surgical instrument in which
safety features are provided to prevent an unsafe overpressure or
an underpressure condition.
Other objects and advantages of the present invention will become
more apparent upon reference to the following specification and
annexed drawings, in which:
FIG. 1 is an overall plan view, taken partly in cross-section, of a
typical instrument for use with the system of the present
invention;
FIG. 2 is a schematic line diagram showing the various components
of the system and their operation, with particular emphasis on the
fluid flow portions of the system and their various components;
and;
FIG. 3 is a schematic diagram of the system particularly
illustrating the electronic control function of the system.
Referring to the drawings, the system is described with respect to
performing an operation on the eye of an animal or a human being.
It should be understood, of course, that the system can be utilized
with at any performance of operations and other types of
environments.
FIG. 1 shows a typical surgical instrument 10 which can be used
with the control. It should be understood, however, that the system
can be used with any type of instrument or instrument set-up which
requires pressurized flow of a liquid (infusion) and/or evacuation
of fluid and severed material from an operating field. This
includes various types of mechanical cutting instruments as well as
other instruments, for example those of the ultrasonic type, which
emulsify material to be removed.
In the embodiment of the invention being described, the tip of
instrument 10 is shown as having pierced through a section of the
eye, for example after an incision has been made. The tip of the
instrument is shown in the vitreous of the eye to remove tissue
therefrom or to treat the eye. The instrument of FIG. 1 also can be
used to remove material from other parts of the eye such as the
lens or iris. It should be understood that the system can be used
with any compatible type of instrument to perform operations or
treatment in any portion of the body of a mammal.
The instrument 10 of FIG. 1 includes an electric motor 2,
preferably of the reversible type, from which extends a collar 3. A
fitting 4 is screwed onto collar 3 and concentric inner and outer
tubular members 12 and 16 extend from fitting 4. Inner tube 12
defines a central passage 14 through which evacuation takes place
over a line 80, to be described below, which communicates with
passage 14 through a coupling on fitting 4. The space between the
inner and the outer tubes 12 and 16 defines a passage 17 through
which infusion fluid is supplied over a line 66 and reverse flow
fluid over a line 70, both of which lines are described below.
Lines 66 and 70 communicate with passage 17 through a common
coupling in fitting 4.
The inner, evacuation flow, member 14 of the instrument has an
opening 19 at the end thereof through which the evacuation flow is
applied to the operation field. The infusion flow member 16 has an
opening 21 in its wall, spaced from opening 19 to avoid
interference, through which fluid is injected into the operating
field. A shaft 6 having a fluted cutter 7 at the end thereof is
located in the inner passage 14. The shaft is connected to the
motor output and rotates in bearings 8 in the fitting 4. Shaft 6 is
preferably biased by a spring 9 so that the cutter 7 will coact
with the surface surrounding the evacuation opening 19 to produce a
shearing action to cut any tissue therebetween. In operation, the
tip of the instrument is moved to place the cutter 7 at the site of
the material to be severed. The evacuation flow from opening 19
aids in drawing the material into a relationship so that it can be
severed by cutter 7. The severed material, in suspension or as part
of an emulsion, is drawn up passage 14 and is removed via passage
14. Infusion fluid is supplied over line 66 to the eye through
passage 17 and its opening 21.
The system of the invention regulates the flow of infusion fluid to
provide a selected predetermined pressure in the eye. In addition
it maintains the evacuation flow rate to within predetermined safe
limits. This is described below.
FIGS. 2 and 3, taken together show the fluid flow and electronic
control system components of the system. In these figures, the
double lines indicate fluid flow paths and the single lines
electrical connections. The infusion fluid supply for the
instrument 10 is illustratively shown as a bottle 60 having a
calibrated scale thereon. In a typical case, saline solution is
utilized as the fluid. The bottle 60 is capped at 62 so that it can
be pressurized over a line 64 which extends into the bottle. The
line 64 can be of any conventional type of tubing, for example,
vinyl tubing, and it is connected to a compressor, or pump, 50.
Pump 50 is any suitable type producing an air flow. The air
entering the infusion bottle is preferably filtered by a suitable
filtering means (now shown) to make it sterile. The pump 50, in
conjunction with various regulating valves, produces a constant
pressure in line 64 and bottle 60 within selectable, relatively
well defined limits, which can be pre-set.
An infusion line 66 also extends into the bottle 60 to receive
fluid therefrom to be conveyed to the outer passage of the
instrument 10. This is the infusion fluid to such passage. An
electromechanically controlled valve 68 is located in line 66
between bottle 60 and the instrument to control the fluid flow.
Line 66 also can be of vinyl or other suitable material.
A second fluid line 70 also receives fluid from the bottle 60. This
is the reverse fluid-flow line whose outlet end is connected to the
instrument 10 to supply fluid to the inner passage 16 of the
instrument. An electromechanically operated valve 69 is located in
line 70 between the bottle 60 and the outlet of reverse flow line
70 to control the flow of fluid to the outlet.
An evacuation mechanism 81 removes the severed or emulsified
material from the eye through an evacuation line 80 which is
connected to the inner passage of the instrument 10. The evacuation
is carried out at a substantially constant rate, which can be
selected and preset, to create a flow of material from the eye in a
substantially gasless column of liquid. The evacuation mechanism
preferably includes a peristaltic type pump, for example, the
Master Flex Tubing Pump, Model 7013 made by Cole-Parmer Company, of
Chicago, Illinois. The operation of this type of pump is described
in greater detail below. Line 80 empties into a waste bottle 82
through the pump and a line 83. The material emptied into bottle 82
includes fluid from the operating field together with the material
severed from the object by the instrument.
Solenoid operated, pressure regulating valves 58, herein
illustratively shown as three in number, 58a, 58b and 58c, are
provided in the pressure line 64 to the bottle 60. Each of these
valves has a pressure set adjustment, indicated by the arrow, to
control or set the pressure in line 64 to the bottle and also to
the instrument. Valves 58 are conventional solenoid operated valves
having, for example, a needle adjustment to set the pressure when
the valve is open.
As described in greater detail below, valve 58a controls the
pressure (P.sub.RD) in the infusion line 66 during the "ready" mode
of the system. This is the lowest pressure. When valve 58a is
operating, both the infusion line control valve 68 and the reverse
flow line control valve 69 are open to prevent any flow of material
from the eye into the instrument 10. Valve 58b sets the pressure
greater than the pressure in the "ready" mode. During the
"operating" mode the infusion line control valve 68 is open and the
reverse flow line control valve 69 is closed. Valve 58c sets the
pressure (P.sub.RV) in the reverse flow line 70 during the
"reverse" mode. This is the highest pressure. When valve 58c is
open, the infusion control valve 68 is closed and the reverse line
control valve 69 is open. As indicated above:
Each of the valves 58, 68 and 69 is of conventional construction
and is operable to an open or a closed condition by a control
circuit generally indicated at 84. The electric signals from the
control circuit 84 are transmitted over signal lines, illustrated
by the single lines, to the various valves to open and close them.
In FIG. 2 the circuit 84 is illustrated in the form of a multi-deck
switch. The three control portions are Operate on the left, Ready
in the center, and Reverse to the right. The single lines back to
the switch indicate that the particular component is energized. The
switch can be a foot switch which has three positions corresponding
to the ready, operate and reverse modes. The ready mode can be a
neutral, or middle, position of the foot switch; operate the
forward position and reverse the rear position.
FIG. 3 illustrates additional details of the electronic control
system as well as additional components of the fluid control
system. In FIG. 3, a tracking tube 82 is located physically above
the level of the liquid supply bottle 60. The tracking tube 82 is
essentially a manometer and can be mounted, for example, on a ring
stand. The level of the liquid in the long arm of the tracking
tube, which for example can be water, is set to the level of the
eye being operated upon. The tracking tube pressure level is
reflected in the infusion line 66, the reverse flow line 70 and the
evacuation line 80, and is used to calibrate the pressure in these
lines to a base, or reference, pressure. As described below, this
is used to avoid excessive high or low pressure in either of these
lines.
A pressure transducer 83 of any suitable conventional type is
connected to the tracking tube 82. Transducer 83 converts the
pressure in tracking tube 82 to an electrical output signal which
is conveyed to an electronic digital readout device 90. The device
90 is calibrated to visually display pressure in terms of mm of Hg.
Any conventional readout device can be used, for example, one of
the digital voltmeter type, made by Data Technology Corp. of Santa
Anna, California, Model 3212-02. Readout 90 receives a signal from
a second transducer 85 which is connected in pressure line 64.
Readout 90 is wired to display the difference between the two
signals from transducers 85 and 83 so that its display represents
the infusion pressure at the operating site. This is the actual
pressure of the infusion fluid supplied to the eye. The output
signal representative of this displayed pressure difference is also
available at the output of readout 90 as an electrical signal.
The pressure above that in the bottle 60 which is required to raise
the liquid level in the infusion line 66 and/or reverse flow line
70 to the level of the liquid in the tracking tube, which is at the
same level as the eye physically, is indicated on readout 90 as the
starting pressure, or zero. This is so when the liquid in the
bottle 60 is at the designated height, which is usually at a
nominal 1,000 cc level. When the level of fluid in the bottle
drops, the reading of the readout 90 is excessive for the amount of
drop of level (a given amount of millimeters of Hg).
Any raising, or lowering, of the pressure in the bottle 60 or the
pressure line 64 will raise, or lower, the level of the liquid in
the infusion line 68 and the reverse flow line 70 and increase, or
decrease, the pressure in the eye. During a typical operation, the
amount of fluid used from the bottle 60 is relatively small so that
the change in pressures caused by this is also minimal.
A pressure sensor 87 is also located in the evacuation flow line 80
to sense the pressure in the line and to produce an electrical
signal representative of it. This signal is supplied to a second
readout device 92 which also receives a signal from the tracking
pressure transducer 83. Device 92 displays in digital form,
calibrated in millimeters of Hg, the difference between the
pressure in line 80 and the tracking tube pressure. That is, the
readout of device 92 is the evacuation flow pressure referenced to
the tracking pressure. An electrical signal representative of the
latter pressure is present at the output of readout 92.
The evacuation mechanism 81 is to be operated to maintain a
constant evacuation flow in line 80. As indicated previously, the
mechanism includes a constant displacement type pump, which in the
preferred embodiment is a peristaltic pump 120 (FIG. 2). This has a
hemispherical housing portion 122 of rigid material and a flexible
plastic tubing 124 within the housing against which a triple arm
roller system 126 rotates. The rollers 127 are spaced about
120.degree. apart. The roller system 126 is rotated by a suitable
motor (not shown) whose speed can be controlled. The inlet to pump
120 is the evacuation line 80 which is preferably a rigid plastic
tubing. The outlet 83 of the pump is to the waste bottle 82.
The peristaltic pump 120 moves a column of liquid in a section A
between two of its rollers 127, creating space for the contents of
section B in tubing 80 between the instrument outlet and the
closest roller 127 of pump 120 to the instrument. Rotation of the
roller on the tubing in the pump 120 in area A creates a flow of
material out of the pump exit passage 83. Fluid is being forced
into the operating field at the time over the infusion line and up
to the pump inlet.
When the peristaltic pump inlet is near the eye and the instrument
is connected to the pump by a relatively short and rigid tube 80,
then the displacement of fluid by the pump is communicated to the
eye with negligible time delay imposed by a flow through the
cutting opening 19 of the instrument.
The system operates in several distinct modes which are described
below:
1. Ready Mode -- To produce this mode of operation the instrument
is turned on and the electrical circuitry is such that the motor
for the cutter of instrument 10 is off and the cutter does not
rotate. Evacuation mechanism 81 is off but pressure pump 50 is
operating. At the same time, valve 58a in the pressure line 64 is
open and valves 58b and 58c are closed. Both the infusion line
control valve 68 and the reverse pressure line control valve 69 are
open. The valve 69 also can be controlled to close, by a signal
from transducer 85, after the pressure in the evacuation line is
close to or reaches the pressure in the eye.
In this mode the pressure of the fluid-flow in infusion line 66 is
most limited, by valve 58a being open, and is being produced only
to maintain the pressure in the operating field and to compensate
for any leakage through the incision in the operating field and the
instrument. This is normally something above the pressure level in
the tracking tube, in the order of 15-20 mm of Hg above zero in a
typical case of the example being described. In general, there is a
small pressure drop in the infusion line 66 between bottle 60 and
the instrument. In the ready mode, the pressure in the evacuation
line 80, as indicated on readout 92 is equal to the pressure in the
infusion line, as indicated by the readout 90, since both control
valves 68 and 69 are open or if valve 69 is controlled to be
closed. At the same time, only pressure regulating valve 58a is
open, thereby producing the same pressure in both lines 66 and 80
at the operating site, either through the connection of the
evacuation and reverse flow lines at the instrument or at the fluid
connection within the operating site provided by the infusion and
the evacuation ports of the instrument. The latter occurs when
valve 69 is closed. When both valves 68 and 69 are open the
pressure in the eye rapidly builds to the proper level to keep it
formed. In a typical case where the eye is being operated on
through an incision which is closed, so that the eye itself is
essentially fluid-tight, this pressure is set at about 15-20 mm of
Hg above atmospheric pressure. In an "open sky" operation, where
the eye is open to the atmosphere, the pressure is kept at zero, or
slightly above, to prevent outflow of material from the eye. A
manually controlled switch (not shown) is also provided, to close
both control valves 68 and 69 after lines 66 and 80 are filled with
fluid. This prevents any movement of fluid into or out of the
instrument which is especially useful during an open sky type
operation.
2. Operating Mode -- This mode is obtained by having the operator
of the system operate the foot switch, for example to the forward
position. This completes electric circuits to turn on both the
pressure pump 50, the evacuation mechanism 81 and to operate the
instrument's electric motor to turn the cutter in the forward
direction. Where other types of instruments are used, for example
an ultrasonic probe or turbo-fragmentator, these would be energized
at this time. At the same time, the operating pressure valve 58b is
opened and valves 58a and 58c are closed. Reverse flow line control
valve 69 is closed and infusion line control valve 68 is
opened.
As described previously, the rate of infusion fluid flow depends on
the rate of evacuation. The maximum incoming rate of infusion fluid
is limited so as not to create prohibitive streaming and consequent
undesired displacement of floating tissue and other substance as in
the operating field, generally near and around the cutting opening
19 of the instrument 10. A high velocity of the incoming infusion
liquid is desirably avoided since it has a mass impulse which may
damage delicate tissue in the operating field.
The pressure in the operating field is to be maintained within
tolerable limits below a desired maximum level, usually less than
30-35 mm of Hg above the atmospheric pressure in the case of a
normal operation on the eye. However, for example, in the case
where there is bleeding in the eye, the pressure can be set to
control the bleeding by increasing it to counteract the pressure of
the blood being pumped by the heart. The evacuation system will
also operate to remove the blood from the operating site permitting
better visualization for cauterizing. After the latter is done, the
pressure can be reduced and the operation continued. Therefore, the
maximum rate of inflow of the infusion fluid must be controlled
and, in some cases, limited. To accomplish this the evacuating
system will not permit the evacuation to exceed a rate such that
the pressure in the operating field can be maintained without
creating undesirably high inflow rates of the infusion fluid.
During the operation mode the material separated by the instrument
cutter is entrained in suspension in the infusion fluid and is
moved to the waste bottle 83 by the evacuation mechanism 81. The
operating pressure in the infusion line is established by valve 58b
being opened. The pressure in the evacuation line 80 depends on
several factors. These are: (1) the cross section of the inlet
opening to the instrument, this changes where there is a movable
cutter; (2) the flow rate of the evacuation mechanism itself; and
(3) the viscosity of the infusion fluid and the material being
removed.
The pump 120 is normally set to rotate at a constant speed to
create a desired flow rate of fluid through the eye. The flow
resistance through the instrument opening 19 and the rest of the
evacuation line 80 is changing continuously during the operation.
When the resistance increases, a greater force is needed to move a
slightly smaller amount of suspension by the pump (the tube 80
shrinks and volume A slightly decreases due to a lower pressure in
portion B of the line). The flow rate decreases slightly through
the instrument cutter opening as well. This occurs as the volume of
portion B of the line 80 decreases (tubing shrinks) due to lower
pressure inside generated by increased resistance at the instrument
opening.
When the resistance at the opening C increases further and the pump
is still moving at a set speed, evacuating the fluid suspension
from volume B, then the pressure in volume B decreases further. If
this process continues the column of liquid in portion of the
tubing B will break and form spaces of low pressure vapors or even
vacuum. And if there is any air or other gases dissolved in the
suspension, they will start to separate and their volume will
increase as pressure in volume B drops further.
So far no damage was done to the eye. Exit of the infusion solution
is blocked, the eye is formed and its inside pressure is at its
maximum desired level. If the resistance at the instrument opening
would decrease slowly and gradually, which seldom happens, then the
flow from the eye will resume and increase gradually until volume B
is filled up again. The outflow from the eye is matched by the
inflow so the eye stays formed. The flow will then stabilize at a
changing level. In a more typical case, the resistance decreases
momentarily, e.g. because the instrument opening is unblocked, and
the volume B, which is partially or totally empty, fills up in a
short time. The flow out of the eye is then greater than the flow
in the eye. The eye loses its desired pressure and it will soften
and collapse. Also, portions of healthy tissue of the eye may enter
the cutter opening of the instrument with disastrous effects.
To prevent this from occurring with the described system, it is
imperative to prevent prohibitive reduction of volume or density of
the fluid suspension in volume B of the evacuating line 80. This is
achieved by keeping B small and its inside pressure relatively
high. Short tubings with a small inner diameter will provide the
small volume. The change in volume in relation to the original
volume will be small if the tubing is made of rigid material
(metal, or thick wall flexible plastic tubins, for example,
TYGON).
When the critical pressure (at which cohesive forces in the liquid
column are exceeded) is reached, the liquid column will break and
liquid-less spaces can be noticed through the wall of a clear
flexible plastic tubing. The pressure level at which this
separation takes place depends on the consistency of the liquid
suspension and its temperature, but it can be clearly established
for a given case. This pressure level can be observed on a pressure
(suction) gauge and the pump can be stopped before it reaches the
undesired level. The liquid column will not break and gases will
not separate if pressure in volume B is kept above a given level.
This may be achieved by stopping the pump prior the critical
pressure is reached.
Separation of gases from the liquid suspension is a third
disturbing factor (the first, shrinkage of tubing, the second,
breakage of liquid column). Gases dissolved in liquid can be
separated at a given (room) temperature if pressure on and in the
liquid is decreased. As before, when pressure in a clear plastic
tubing is sufficiently reduced, at first a small quantity of very
small gas bubbles appear in the liquid and as pressure is further
reduced the number and size of the bubbles increases. The pressure
at which the separation starts to be apparent can be observed on a
pressure gauge and if the pump is stopped before the pressure
reaches the undesired value, the separation will not occur. If some
small degree of separation occurs it will not be harmful in terms
of the problem described.
In either case if breaking of the column or fluid or separation of
gases, pump 81 can be stopped manually if and when the observed
conditions in portion of the line B visually appear to become
critical. Pump 120 also can be stopped automatically, for example,
pressure transducer 82 regulates the pressure in line 80. The
transducer 87 produces a signal which is supplied to control
circuit 96. If the pressure in line 80 falls below a predetermined
minimum value, which can be selected and preset into the evacuation
control circuit 96, the latter circuit produces an output signal
which shuts off mechanism 81. In a typical embodiment of the
invention, this is designed to occur when the pressure in
evacuation line 80 is at between about 150 to 760 mm of Hg below
atmosphereic pressure. This is a safety feature of the system.
When, and if, the flow from the eye through the cutter opening 19
of the instrument resumes (or increases) the pressure in volume B
will increase and the pump can be started again, manually or
automatically. In the latter case, the evacuation control circuit
produces an output signal in response to the pressure sensed by
transducer 82 to start the mechanism 81 again. A 10% pressure
margin between OFF and ON has been found to be satisfactory.
If flow of liquid from the eye stops, or is reduced due to the
blockage of evacuation port 19, or the viscosity of the tissue,
entering the port 19 is increased, then the pressure in line 80
drops and transducer 87 triggers the control circuit 96 to stop
mechanism 81. The pump 120 is stopped and since the portion B of
line 80 is not occupied by expanding or compressive spaces which
are empty or filled up with rarefactored gases, the flow from the
eye will stop soon after the pump is stopped. The delay time
depends on the difference in pressure in line 80 and in the eye,
since the shrinkage of volume B depends on the magnitude of this
differential pressure. When the pump is stopped and flow continues
out of the eye until pressure in the eye is equalized with the
pressure in line B.
In order to prevent a flow of liquid from the eye after the pump is
stopped, liquid should be brought in portion B of line 80 from the
reverse flow line 70 until equilibrium is achieved between pressure
in the eye and pressure in portion B. This is done by opening the
reverse flow control valve 69 when the evacuation process is
stopped. Valve 69 is normally closed during the evacuation process.
It also can be closed during the ready mode when the pressure in
the evacuation line approaches or is equal to the pressure in the
eye.
As an alternative the pump 120 could be turned in the opposite
direction to deliver liquid and increase the pressure in portion B
of line 80 until equilibrium between the pressure in the eye and
the pressure in portion B is achieved. Turning of the pump in the
opposite direction can be accomplished by operating a specific
switch by hand and keeping the pump running until the observed
pressure reaches a specific value on a pressure gauge in line 80.
It also can be done automatically as the pump is being de-energized
from providing fluid flow from the eye it can be energized to
produce a reverse flow until a predetermined value of pressure or
equilibrium between pressure in the eye and pressure in portion B
of line 80 is reached. The reverse flow into portion B of
evacuation line 80 is produced by a fixed or adjustable pressure in
the bottle 60 until the pressure in the portion B has reached a
desired fixed or adjustable value. This is determined by the
transducer 87 and circuit control 96. As another alternative, when
the operation is being performed in an open eye, the adjusted or
adjustable flow is made to take place for a fixed or adjustable
length of time.
The same result obtained by reversing the pump, either
automatically or manually, can be accomplished by opening the
clamping mechanism of the pump so that portion B of the evacuation
line 80 communicates with the exit 82 of the line. Since the
resistance on the pump side of portion B of line 80 is smaller than
at the opening of the instrument, the flow into B will take place
from the pump side until equilibrium is reached between pressure in
portion B of the evacuation line and the eye. The exit 82 of the
outflow line must be above the level of the eye by a determined
height to prevent syphoning.
Since it is not practical to have a pressure sensor in the eye it
is impossible to define and keep track of its internal pressure at
any and every particular instance during the operation. Thus,
equilibrium between pressure in portion B of the evacuation line 80
and the eye is never really reached when the pump is turned
backward. The accommodation of restoring pressure in portion B of
the evacuation line should be to minimize and not eliminate
entirely the flow from the eye after the flow is not desired or
needed any longer, and the pump 120 is deactivated.
3. Reverse flow mode -- This is obtained by the operator moving the
control switch to another position, illustratively backwards on the
foot switch. When this is done, the electrical controls are set up
such that direction of rotation of the instrument cutter motor is
reversed and the evacuation mechanism 81 is stopped. Pressure
valves 58a and 58b are closed and valve 58c is left open to set up
the reverse pressure in line 70. The infusion line control valve 68
is closed and the reverse flow line control valve 69 is opened.
The high pressure flow of reverse flow fluid is supplied from
bottle 60 to line 70 and to the opening 19 for the cutter in the
instrument 10 to push away any material that might have clogged
this opening or inadvertently entered the cutter opening.
A fourth mode of flow is created through the reverse flow line 70
after the evacuation process through line 80 is terminated. This
equalizes the pressure on both sides of the evacuating port of the
instrument which is in the operating field.
In accordance with the general principle of the invention, if
desired, the infusion fluid can be supplied to the instrument over
a separate supply line during the reverse flow mode and a separate
pump can be used for the reverse flow mode. The separate pump and
supply line can also have its own control circuit so that the
pressure in the line will not be excessive.
As a further alternative one or two of the valves 58a, 58b or 58c
can be eliminated. For example, valve 58a could be removed and the
ready mode pressure is controlled by valve 58b at the operating
pressure. Further, only valve 58b could be used so that line 64
would have the same pressure during all three modes of operation.
Neither one of these alternatives is as desirable as having the
three valves.
The pressure in infusion bottle 60 also can be produced, maintained
or changed by a system having a displacement type pump (e.g. a
peristaltic or other suitable pump) for determining the amount of
air pressed into the bottle or removed from it in order to maintain
or regulate the desired pressure in the bottle at all stages of
operation. This would be in response to control signals produced by
the pressure transducer. A safety pressure valve is preverably used
to prevent unwanted increases in pressure of the electronic
circuit.
* * * * *