U.S. patent number 3,693,613 [Application Number 05/096,473] was granted by the patent office on 1972-09-26 for surgical handpiece and flow control system for use therewith.
This patent grant is currently assigned to Cavitron Corporation. Invention is credited to Charles Kelman.
United States Patent |
3,693,613 |
Kelman |
September 26, 1972 |
SURGICAL HANDPIECE AND FLOW CONTROL SYSTEM FOR USE THEREWITH
Abstract
A flow control system is used in conjunction with a surgical
handpiece for the removal of unwanted material in a very small
enclosed operative site in which it is very critical to maintain a
pressure within a certain range, such as in the surgical operation
of the removal of a cataract lens from the human eye. The system
includes an irrigation subsystem comprising a source of treatment
fluid, such as an artificial aqueous solution, at a preselected
constant pressure for supplying said fluid to the enclosed
operative site via the handpiece. A suspension of the treatment
fluid, including any unwanted material, is removed from the
operative site by an aspiration subsystem. The aspiration subsystem
comprises a pump used to remove the suspension and to overcome the
friction and other losses throughout the entire fluid system, a
flow transducer for measuring the rate of flow, and a vent valve to
reduce the flow in the aspiration subsystem when necessary to
assist in maintaining a relatively constant pressure within the
operative site. An electronic flow control receives signals from
the flow transducer and reacts to certain changes in flow signals
by sending a signal to the venting valve.
Inventors: |
Kelman; Charles (New York,
NY) |
Assignee: |
Cavitron Corporation (Long
Island City, NY)
|
Family
ID: |
22257489 |
Appl.
No.: |
05/096,473 |
Filed: |
December 9, 1970 |
Current U.S.
Class: |
606/169; 417/300;
604/31; 137/115.03; 604/22; 606/107 |
Current CPC
Class: |
A61F
9/00745 (20130101); A61B 2017/320084 (20130101); A61B
2017/00973 (20130101); Y10T 137/2579 (20150401); A61M
1/85 (20210501) |
Current International
Class: |
A61F
9/007 (20060101); A61B 17/32 (20060101); A61B
17/00 (20060101); A61M 1/00 (20060101); A61h
001/00 (); A61b 017/00 (); G05d 011/02 () |
Field of
Search: |
;128/24A,278,303,303.1
;137/117 ;417/300 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Claims
I claim:
1. Flow control system for removing a suspension of unwanted
material in a treatment fluid from an enclosed operative site
comprising,
a source of treatment fluid at a certain pressure for causing said
fluid to flow into the enclosed operative site including hydraulic
tubing for connecting said treatment fluid source to the enclosed
operative site,
a source of negative pressure for withdrawing the suspension from
the enclosed operative site including hydraulic tubing for
connecting said negative pressure source to the enclosed operative
site,
a flow transducer intermediate of and interconnected by the
hydraulic tubing between the negative pressure source and the
enclosed operative site, for sensing the flow of suspension and for
generating an electrical signal proportional to said flow,
a vent valve coupled to the hydraulic tubing between said flow
transducer and said negative pressure source for venting the flow
of the suspension to atmospheric pressure, and
electronic flow control means electrically interconnected to said
flow transducer and said vent valve for sending an electrical
signal to said vent valve for venting the hydraulic tubing through
which said suspension flows upon sensing a predetermined
signal.
2. A flow control system in accordance with claim 1, wherein said
electronic flow control means senses certain changes in flow rates
due to the signals received from the flow transducer and at a
certain predetermined value, sends an electrical signal to the vent
valve for venting the hydraulic tubing through which said
suspension flows.
3. A flow control system in accordance with claim 1, further
involving a bypass reservoir and a solenoid operated valve located
intermediate of and interconnected by the hydraulic tubing between
the flow transducer and the negative pressure source, the solenoid
operated valve having a first position wherein the suspension only
flows from the flow transducer to the negative pressure source, and
having a second position wherein fluid only flows from the bypass
reservoir to the negative pressure source.
4. A flow control system in accordance with claim 1 wherein
the source of treatment fluid includes two separate sources of
fluid each of which has a different pressure, and
said flow control system further including
switch means having at least two positions, said first switch
position coupling only the source of treatment fluid having the
lower pressure to the enclosed operative site, said second switch
position coupling the source of treatment fluid having the higher
pressure and the negative pressure source to the enclosed operative
site, with the vent valve receiving an electrical signal to vent
the hydraulic tubing between the flow transducer and the negative
pressure source whenever the switch means moves between these two
positions.
5. Flow control system for removing a suspension of unwanted
material in a treatment fluid from a small enclosed operative site
comprising,
a first source of treatment fluid at a certain pressure for causing
said fluid to flow into the enclosed operative site including
hydraulic tubing for connecting said first treatment fluid source
to the enclosed operative site,
a second source of treatment fluid at a pressure higher than the
first source for causing said fluid to flow into the enclosed
operative site including hydraulic tubing for connecting said
second treatment fluid source to the enclosed operative site,
a source of negative pressure for withdrawing the suspension from
the enclosed operative site including hydraulic tubing for
connecting said negative pressure source to the enclosed operative
site,
a flow transducer intermediate of and interconnected by the
hydraulic tubing between the negative pressure source and the
enclosed operative site, for sensing the flow of the suspension and
for generating an electrical signal proportional to said flow,
a vent valve coupled to the hydraulic tubing between said flow
transducer and said negative pressure source for venting the flow
of the suspension to atmospheric pressure,
electronic flow control means electrically interconnected to said
flow transducer and said vent valve for sensing certain changes in
flow rates due to the signal received from said flow transducer
and, at certain predetermined value, for sending an electrical
signal to the vent valve for venting the hydraulic tubing through
which said suspension flows, and
a switch means having at least two positions, said first switch
position coupling only the first source of treatment fluid to the
enclosed operative site, said second switch position coupling the
second source of treatment fluid and the negative pressure source
to the enclosed operative site, with the vent valve receiving an
electrical signal to vent the hydraulic tubing between the flow
transducer and the negative pressure source whenever the switch
means moves between these two positions.
6. A flow control system in accordance with claim 5 further
including
a bypass reservoir, and
a solenoid operated valve located intermediate of and
interconnected by the hydraulic tubing between the flow transducer
and the negative pressure source, having a first position wherein
the suspension only flows from the flow transducer to the negative
pressure source, and having a second position wherein fluid only
flows from the bypass reservoir to the negative pressure
source.
7. The combination of a surgical handpiece and a flow control
system for removing a suspension of unwanted material in a
treatment fluid from an enclosed operative site wherein said
surgical handpiece comprises
a fluid inlet channel for treatment fluid to enter the enclosed
operative site,
a fluid outlet channel for the suspension of unwanted material in
the treatment fluid to exit from the enclosed operative site,
and
wherein the flow control system comprises
a first source of treatment fluid at a certain pressure for causing
said fluid to flow into the enclosed operative site, including
hydraulic tubing for connecting said first treatment fluid source
to the enclosed operative site,
a second source of treatment fluid at a pressure higher than the
first source for causing said fluid to flow into the enclosed
operative site, including hydraulic tubing for connecting said
second treatment fluid source to the enclosed operative site,
a source of negative pressure for withdrawing the suspension from
the enclosed operative site including hydraulic tubing for
connecting said negative pressure source to the enclosed operative
site,
a flow transducer intermediate of and interconnected by the
hydraulic tubing between the negative pressure source and the
enclosed operative site, for sensing the flow of the suspension and
for generating an electrical signal proportional to said flow,
a vent valve coupled to the hydraulic tubing between said flow
transducer and said negative pressure source for venting the flow
of the suspension to atmospheric pressure,
electronic flow control means electrically interconnected to said
flow transducer and said vent valve for sensing certain changes in
flow rates due to the signal received from said flow transducer
and, at a certain predetermined value, for sending an electrical
signal to the vent valve for venting the hydraulic tubing through
which said suspension flows, and
a switch means having at least two positions, said first position
coupling only the first source of treatment fluid to the enclosed
operative site, said second switch position coupling the second
source of treatment fluid and the negative pressure source to the
enclosed operative site, with the vent valve receiving an
electrical signal to vent the hydraulic tubing between the flow
transducer and the negative pressure source whenever the switch
means moves between these two positions.
8. The combination as described in claim 7, wherein the flow
control system further includes
a bypass reservoir, and
a solenoid operated valve located intermediate of and
interconnected by the the hydraulic tubing between the flow
transducer and the negative pressure source, having a first
position wherein the suspension only flows from the flow transducer
to the negative pressure source, and having a second position
wherein the fluid only flows from the bypass reservoir to the
negative pressure source.
9. The combination of a surgical handpiece and a flow control
system for removing a suspension of unwanted material in a
treatment fluid from an enclosed operative site wherein said
surgical handpiece comprises
a fluid inlet channel for treatment fluid to enter the enclosed
operative site,
a fluid outlet channel for the suspension of unwanted material in
the treatment fluid to exit from the enclosed operative site,
and
a vibratory body, coupled to a source of high frequency electrical
energy, for converting said electrical energy to high frequency
mechanical vibrations, and coupled to a source of coolant for
cooling a portion of said vibratory body, and
wherein the flow control system comprises,
a first source of treatment fluid at a certain pressure for causing
said fluid to flow into the enclosed operative site, including
hydraulic tubing for connecting said first treatment fluid source
to the enclosed operative site,
a second source of treatment fluid at a pressure higher than the
first source for causing said fluid to flow into the enclosed
operative site, including hydraulic tubing for connecting said
second treatment fluid source to the enclosed operative site,
a source of negative pressure for withdrawing the suspension from
the enclosed operative site, including hydraulic tubing for
connecting said negative pressure source to the enclosed operative
site,
a flow transducer intermediate of and interconnected by the
hydraulic tubing between the negative pressure source and the
enclosed operative site, for sensing the flow of the suspension and
for generating an electrical signal proportional to said flow,
a vent valve coupled to the hydraulic tubing between said flow
transducer and said negative pressure source for venting the flow
of the suspension to atmospheric pressure,
electronic flow control means electrically interconnected to said
flow transducer and said vent valve for sensing certain changes
rates flow rtes due to the signal received from said flow
transducer and, at a certain predetermined value, for sending an
electrical signal to the vent valve for venting the hydraulic
tubing through which said suspension flows, and
a switch means having three positions, said first switch position
coupling only the source of treatment fluid having the lower
pressure to the enclosed operative site, said second switch
position coupling the source of treatment fluid having the higher
pressure and the negative pressure source to the enclosed operative
site, and said third switch position coupling the source of
treatment fluid having the higher pressure and the negative
pressure source to the enclosed operative site and energizing the
high frequency vibratory body; with the vent valve receiving an
electrical signal to vent the hydraulic tubing between the flow
transducer and the negative pressure source whenever the switch
means moves between the first and second positions.
Description
BACKGROUND OF THE INVENTION
The present invention relates to a flow control system to be used
with surgical handpiece, the combination of which is primarily
concerned with the removal of tissue from any enclosed or
semi-enclosed operative site. This flow control system is
particularly of interest and value where it is important that the
pressure in the operative site be maintained within relatively
narrow limits and particularly where the total volume of the
operative site chamber is very small in relation to the rest of the
fluid in the system. Although by no means limited thereto, the
present system is of particular advantage when used with an
ultrasonic handpiece for the removal of a cataract lens in the
human eye.
The usual procedure in the removal of a cataract lens from a human
eye often involves a 180.degree. incision allow the surgeon to lift
up the cornea and lift out the lens in toto. The flow control
system of this invention makes it possible to remove a cataract
lens from a human eye by making only a small incision in the eye
and inserting the tip of the surgical handpiece therein so that the
tip is within the anterior chamber (operative site) of the eye
providing access to the lens.
One type of handpiece, (hereinafter to be referred to as the
ultrasonic handpiece), includes a source of vibratory motion as
well as a passage for treatment fluid to flow into the anterior
chamber (operative site) and a passage for the fluid and unwanted
material (hereinafter to be referred to as the suspension), to exit
from the anterior chamber (operative site). The combined or
separate action of the flowing fluid and/or the force of the
vibratory motion of the handpiece when in contact with or adjacent
to the lens of the eye will cause the lens to break apart and be
removed from the eye. One example of such a handpiece is disclosed
in the copending application of A. Banko and C. Kelman, Ser. No.
655,790 filed July 25, 1967 entitled "Material Removal Apparatus
Employing High Frequency-vibration", now U.S. Pat. No. 3,589,363
dated June 29, 1971 and assigned to he assignee of this
application. Discussion throughout this specification of
maintaining a relatively constant pressure is intended to refer
only to the pressure caused by the treatment fluid and not to any
effect of the acoustic pressure waves caused by the ultrasonic
vibrations. The latter effects can be neglected with respect to the
flow parameters of interest to the invention disclosed herein.
Another type of handpiece, (hereinafter to be referred to as the
irrigation-aspiration handpiece), merely contains two passages for
flow into and out of the operative site. It is usually used during
a type of "cleaning up" procedure within the enclosed operative
site, though may be used as an alternative to the ultrasonic
handpiece where the unwanted material is particularly soft and does
not require the use of ultrasonics to break it apart.
When the handpiece is inserted into the eye or operative site, and
in the case of the eye, the anterior chamber, it is very important
that the pressure of the anterior chamber is maintained within a
certain range of values, since otherwise various portions of the
eye could be damaged. A collapse of the anterior chamber could
result in either the iris, the endothelium layer of the cornea, or
the posterior capsule, as well as other parts coming into contact
with that portion of the handpiece within the eye which is
connected to a source of fluid suction as well as a source of high
frequency vibration, either of which could cause damage to one or
more of the above-named parts of the eye. This problem of
maintaining the proper pressure is a particularly difficult and
sensitive one in the case of an operative site wherein the volume
of said operative site considerably smaller than the volume of
fluid which is necessary for the irrigating and aspirating
subsystems connected to the handpiece for maintaining the necessary
flow to and from the operative site. In addition, as in the case of
a cataract operation, when the lens or portions thereof are drawn
towards the surgical handpiece tip within the operative site, there
is a possibility of particles which are bigger than the exit
passage from the operative site to occlude the fluid line in the
tip portion of the handpiece leading to the aspiration subsystem.
When this occlusion occurs, there is an increased negative pressure
or suction in the fluid line between the operative site and the
pump which is assisting in the aspirating of the fluid out of the
operative site. When the occlusion is finally removed, whether it
be by the mechanical action of the ultrasonic tip or by an increase
in the value of the aspirating force at the tip of the handpiece or
due to any other reason, the flow control system is designed so
there is an extremely rapid equalization of the pressure in the
entire system. If there were no such equalization of the pressure,
then due to this increased negative pressure or suction in the
aspiration line, there would be a tendency for all of the fluid
volume of the operative site to be suddenly conducted through the
handpiece towards the pump once the occlusion is removed. This is
especially true where the volume of the operative site is small
relative to the volume of the remainder of the fluid system. This
could result in anywhere from a partial to a total collapse of the
enclosed operative site resulting in undesirable damage.
Therefore, it is an object of the present invention to provide a
flow control system for keeping the pressure within an enclosed or
semi-enclosed operative site at a relatively constant level.
Another object of this invention is to provide a flow control
system for keeping the pressure within an enclosed or semi-enclosed
operative site relatively constant while forcing a fluid through
said chamber for the removal of unwanted material from said
chamber.
A further object of the invention is to provide a flow control
system for keeping the pressure in a small enclosed or
semi-enclosed operative site relatively constant while forcing a
fluid through said operative site and applying a high frequency
mechanical vibratory force to a material within said chamber
resulting in the breaking apart and removal of said material.
A still further object of the invention is to provide a flow
control system which is sufficiently sensitive to certain changes
in flow rates such that prior to any significant collapse of an
enclosed site, an adjustment is made on the fluid system to avoid
said collapse.
BRIEF DESCRIPTION OF THE DRAWINGS
For a fuller understanding of the nature and objects of this
invention, reference should be made to the following detailed
disclosure taken in connection with the accompanying drawings in
which:
FIG. 1 is a cross-sectional view of an ultrasonic handpiece showing
its basic internal construction;
FIG. 2 is a cross-sectional view of an irrigation-aspiration
handpiece showing its basic internal construction;
FIG. 3 is a pictorial representation of a human eye in enlarged
form and illustrating the use of a surgical handpiece in cataract
removal; and
FIG. 4 is a schematic diagram of the combination of the ultrasonic
handpiece and the flow control system.
DESCRIPTION OF THE EXEMPLARY EMBODIMENTS
Referring to FIG. 1, the ultrasonic handpiece 10 includes a
proximal end 11 and a distal end 12 and hydraulically coupled to a
power and coolant supply 15 (FIG. 4) at its proximal end 11 via a
coolant fluid inlet tube 16 and a coolant fluid outlet tube 17 and
a pair of electrical leads 18. The electrical leads 18 are
connected to coil 19 which is wound internally within the
ultrasonic handpiece 10. Within said handpiece, there is a
vibratory body 20 containing a transducer element 21 at the
proximal end 11 of said vibratory body 20. The transducer element
which may be either magnetostrictive or electrostrictive type
converts the high frequency alternating current generated in the
coil 19 into high frequency mechanical vibrations. The transducer
element 21 is energized by the coil 19 containing the high
frequency electrical signal and the resulting mechanical vibrations
are transmitted via a connecting body 22 to an operative tip 23 at
the proximal end 12 of the handpiece 10. The high frequency
electrical signal is provided by a circuit (not shown) in the power
and coolant supply 15. There are many such circuits which are well
known in the art and need not be further described here.
Due to the heat generated in the transducer element 21 by the
electrical-to-mechanical energy conversion occurring in the
ultrasonic handpiece 10, especially if it is of a magneto strictive
type, a source of coolant is provided by the power and coolant
supply 15, and it is carried to and from the handpiece 10 by the
coolant fluid inlet and outlet tubes 16 and 17.
The other major elements of the handpiece 10 which are coupled to
the irrigation and aspiration subsystems of the flow control
system, respectively, are a fluid inlet channel 24 and a fluid
outlet channel 25. The fluid inlet channel 24 connects with an
annular passage 26 within the ultrasonic handpiece 10 which
surrounds the connecting body 22 and the operative tip 23 and
terminates at the very distal end 12 of the handpiece 10. The fluid
outlet channel 25 connects with a bore 27 through the center of the
connected body 22 and with the bore 28 through the center of the
operative tip 23 termination at the very distal end 12 of the
handpiece 10. For more details on the operation of such an
ultrasonic handpiece reference is made to the above-named copending
patent application.
Referring to FIG. 2, the irrigation-aspiration handpiece 30, having
proximal end 31 and a distal end 32 has a fluid inlet channel 34
coupled to the irrigation subsystem of the flow control system. The
fluid from the irrigation subsystem flows through an annular space
35 within the handpiece and exits at the distal end 32. The
suspension from the operative site flows through a center bore 36
and exits at the fluid outlet channel 37 at the proximal end 31 of
the handpiece 30. The fluid outlet channel 37 is coupled to the
aspiration subsystem of the flow control system.
While the invention system can be used for the removal of material
from any enclosed volume, particularly a volume in which the
maintenance of a relatively constant pressure is critical, some of
the discussion in this disclosure will refer to the removal of a
cataract lens from the human eye as one particular example. The use
of a surgical handpiece as applied to cataract removal is
illustrated in FIG. 3. A portion of a simplified cross-section of a
human eye is shown to illustrate the manner in which the device is
employed.
Referring to FIG. 3, the opaque or cataract lens which is to be
removed is designated by the number 40, and is enclosed in a
membrane including an outer portion 40a known as the anterior
capsule. The iris is designated by the numeral 41 and the major
gel-filled portion of the eye, or vitreous, is designated as 42.
The cornea, the transparent outer surface of the eye, is shown as
43, and the portion of the eye generally called the anterior
chamber is designated as 45. A small incision 46 is made near the
edge of the cornea 43 to provide access for the distal end 12 of
the ultrasonic handpiece 10 or the distal end 32 of the
irrigation-aspiration handpiece 30.
Referring to FIG. 4, the dotted lines represent electrical
connections and the solid lines represent hydraulic connections.
Those components of the flow control system which are hydraulically
coupled to the fluid inlet channel 24 of the ultrasonic handpiece
10 are part of the irrigation subsystem and those components which
are hydraulically coupled to the fluid outlet channel 25 are part
of the aspiration subsystem.
The irrigation subsystem comprises a treatment fluid supply 50
having a pressure P.sub.1 and a treatment fluid supply 55 having a
pressure P.sub.2, with P.sub.2 being greater than P.sub.1. The
treatment fluid is preferably a solution, which is compatible with
the tissue being treated. For purposes of cataract removal, an
artificial aqueous solution has been found to be satisfactory. The
treatment fluid supplies 50 and 55 are connected to the fluid inlet
channel 24 of the ultrasonic handpiece 10 by hydraulic tubing
56.
The function of the aspiration subsystem is to remove from the
enclosed operative site (in the case of the eye it is the anterior
chamber 45, see FIG. the excess treatment fluid and/or any other
unwanted material which the surgeon may want to signal removed. The
fluid and other unwanted material being removed from the enclosed
operative site shall hereinafter be referred to as the suspension.
All the components of the aspiration subsystem are interconnected
and connected to the fluid outlet channel 25 of the ultrasonic
handpiece 10 by hydraulic tubing 58, hereinafter to be referred to
as the main suction line.
The aspiration subsystem includes a flow transducer 60, which is
the first major component downstream from the handpiece 10 along
the main suction line 58. The flow transducer 60 does not impede
the flow of the suspension, but it is designed to sense the flow
rate and produce a corresponding electrical signal which is
transmitted to the electronic flow control 70, which will be
discussed in more detail later. The flow transducer 60, which is a
commercially available product, is an electromagnetic device which
produces an electrical signal proportional to the flow velocity of
the suspension. The flow transducer 60 is energized by the master
control panel 80.
The next major component in the aspiration subsystem downstream
from the flow transducer 60 and along the main suction line 58 is
the by-pass valve 90. Also connected to the by-pass valve via a
tube 99 is a by-pass reservoir 100. The by-pass valve 90 is a
double action solenoid such that in one position, to be referred to
as its aspiration position, the suspension is allowed to flow
unimpeded through the main suction line 58 and there is no flow in
tube 99. In the other position of the solenoid, to be referred to
as its by-pass position, there is no flow of the suspension while
the solution from the by-pass reservoir 100 is allowed to flow.
The next major component in the aspiration subsystem downstream
from the by-pass valve 90 and along the main suction line 58 is the
pump 110. The pump 1110 is a constant displacement, variable speed,
peristaltic pump. The peristaltic feature is to avoid any contact
of the pump with the suspension hence minimizing maintenance
problems of the pump 110, and the tubing can be easily removed from
the pump for the purposes of sterilization. The constant
displacement feature is necessary in order to insure accurate
sensing of flow by the flow transducer 60, especially due to the
exceedingly small fluid volume of the anterior chamber 45 of the
eye relative to the fluidic volume of the remaining hydraulic
components of the system.
Another component of the aspiration subsystem is the by-pass
reservoir 100, coupled to the main suction line 58 via the by-pass
valve 90. When the solenoid of the by-pass valve 90 switches to its
by-pass position, the flow from the flow transducer 60 ceases,
hence the aspiration of the anterior chamber 45 of the eye ceases,
and instead there is a flow from the by-pass reservoir 100. The
by-pass reservoir 100 is used to insure that fluid fills all
portions of the main suction line 58 at all times, so that the
hydraulic response time of the system is kept to a minimum. Thus,
even though suction at the handpiece 10 may not be desired, from
time to time, the continuously running pump 110 is always ready to
apply the required suction, wherever necessary.
Another component of the aspiration subsystem is the vent valve 120
which is intermediate of the by-pass valve 90 and the pump 110. The
vent valve 120 is a spring loaded, electrically operated solenoid
which is normally in a shut position. An electrical signal from the
electronic flow control 70 causes the vent valve 120 to open and
close to complete a cycle. What determines the existence of such a
signal shall be discussed in more detail later. The function of the
vent valve 120 is to provide for a pressure equalization between
atmospheric pressure and the hydraulic pressure in the main suction
line 58, hereinafter to be referred to as venting, hence negating
pressure buildup in the aspiration subsystem upon removal of the
occlusion. The master control panel 80 selectively enables the vent
valve 120. This allows the vent valve 120 to become inoperative so
that the system can be started prior to the commencement of an
operation. The electronic flow control 70 has a control for
adjusting the amount of time the vent valve 120 remains open.
In the operation of the components heretofore described, a suitable
footswitch 130, having a foot-actuated control arm 135 with a
conductive segment 136, is uses, having an "off" position, three
stable "on" positions and a fourth position to be called the
transition position or position T. Position T results only when the
control arm 135 moves between two of its stable "on" positions.
While nothing is activated in the "off" position, it is important
to note that the solenoid of the by-pass valve 90 is in its by-pass
position at this time. This would allow sterilized solution from
the by-pass reservoir 100 to flow through a portion of the
aspirat1on subsystem, assuming the pump 110 is in operation. The
footswitch 130 has no switching function with respect to the pump
110.
In footswitch position 1, (hereinafter the irrigation position),
since the conductive segment 136b of the control arm 135 bridges
the pair of spaced contacts 137, the treatment fluid supply 50 is
actuated, such that the treatment fluid at a pressure P.sub.1 flow
to the fluid inlet channel 24. The solenoid of the by-pass valve 90
remains in its by-pass position.
In footswitch position 2, (hereinafter the irrigation and
aspiration position), since the conductive segment 136b of the
control arm 135 bridges the pair of spaced contacts 138, the
treatment fluid supply 55 is actuated such that the treatment fluid
at a pressure P.sub.2 flows to the fluid inlet channel 24. In
addition, since the conductive segment 136c of the control arm 135
bridges the pair of spaced contacts 139, the by-pass valve 90
changes to its aspiration position.
In footswitch position 3, (hereinafter the ultrasonic position),
since the conductive segments 136b and 136c bridge the pair of
spaced contacts 141 and 142, it can be seen that the irrigation and
aspiration subsystems remain in the same state as when the control
arm 135 was in footswitch position 2. However, in addition, since
the conductive segment 136a bridges the pair of spaced contacts
143, the circuit (not shown) of the power and coolant supply 15 is
coupled to the ultrasonic handpiece 10, assuming the power and
coolant supply 15 has already been energized by the master control
panel 80. This results in high frequency vibrations of the
operative tip 23 of the vibratory body at the proximal end 12 of
handpiece 10. Simultaneous to this, a pressurized coolant is caused
to flow to the handpiece 10 and back to the power and coolant
supply 15 via the coolant inlet an outlet tubes 16 and 17. All the
other controls of the power and coolant supply 15 are on the master
control panel 80 including the on-off switch, the power level
control of the circuit and the pressurizing of the coolant
supply.
Position T, (the transition position) of the footswitch 130, occurs
whenever the footswitch control arm 135 moves from position 1 to
position 2 or vice versa. During such movement the conductive
segment 136b bridges the pair of spaced contacts 144 which causes
actuation of the electronic flow control 70 such that an electrical
signal is sent to the vent valve 120 causing a venting of the main
suction line 58, hence an equalization of the pressure in the
entire aspiration subsystem.
A functional description of the electronic flow control 70 is
necessary to tie together the entire system. The electronic flow
control 70, which is energized by the master control panel 80,
continually receives signals from the flow transducer 60 concerning
the flow rate of the suspension and contains circuitry to
differentiate these signals such that an electrical signal results
whenever certain changes in the flow rate signals occur. The
circuitry is designed so that whenever the flow rate falls below a
first predetermined value and subsequently increases above a second
predetermined value, a pulse is generated and sent to the vent
valve 120. This results in the venting of the main suction line 58
causing the momentary elimination of the negative pressure at the
bore 28 of the operative tip 23 and substantially reducing the flow
of the suspension through the main suction line 58. The circuitry
of the electronic flow control 70 is designed so as to account for
all of the fluidic parameters of the entire system.
In addition, the circuitry of the electronic flow control 70 is
designed so that whenever certain irregular conditions are sensed,
such as the passage of air bubbles or lens particles through the
flow transducer 60 or an impact against or constriction of one of
the hydraulic tubes in the aspiration subsystem, the electronic
flow control 70 will send an electrical signal to the vent valve
120.
While FIG. 4 illustrates the use of the flow control system with
the ultrasonic handpiece 10, it would be equally applicable with
the irrigation-aspiration handpiece 30 except that footswitch
position 3 would be inapplicable.
Set-up and Operation of the System
Before commencing an actual operation it is necessary to set the
pressures P.sub.1 and P.sub.2 and the speed of the pump 110 to
within the approximate range that will be required for the
operation. A rubber type chamber is positioned over the tip and
P.sub.1, P.sub.2 and the pump speed are set by observing the
effects on the rubber chamber. The desired effects on the rubber
chamber are determined empirically by past experience.
Since P.sub.1 is used when the footswitch is in position 1 and
there is no aspiration, it must be set at a value such that it will
mantain the enclosed operative site at a relatively constant volume
taking into account the pressure drops throughout the irrigation
subsystem and the fluid and/or suspension which may flow from the
enclosed operative site through the incision leakage around the
proximal end of the handpiece.
P.sub.2 must be at a value higher than P.sub.1 since it will be
used when the footswitch is in position 2 when there is aspiration
due to the operation of the pump.
It is also necessary to prime the fluid system prior to start of
the operation. During this priming operation, the flow transducer
60 and the electronic flow control 70 will remain de-energized from
the master control panel 80. Otherwise, continual venting would
make the priming of the system very difficult, if not
impossible.
It is also necessary to choose the power level for the circuit in
the power and coolant supply 15. The power level determines the
amplitude of that portion of the operative tip 23 which comes into
contact with the cataract lens. Usually the minimum possible power
level to accomplish the task is chosen.
The electronic flow control 70 requires certain internal balances
of its electrical components to take into account the ambient
factors of the operating room and needs to be energized prior to
the commencement of an operation to stabilize it as to temperature,
transient signals, etc. Therefore, after the priming of the entire
irrigation and aspiration subsystems has been completed, the flow
transducer 60 and the electronic flow control 70 are energized.
Then while the entire system is operating at its maximum desired
flow, as determined by the various settings discussed above, the
electronic flow control 70 is programmed to read such a flow as the
maximum flow rate. Then an artificial occlusion is placed along the
aspiration subsystem as close to the distal end 12 of the handpiece
10 as possible. The electronic flow control 70 is then programmed
to sense this as the minimum flow rate. These minimum and maximum
flow rates plus the circuitry of the electronic flow control 70
which has been designed to take into account all the parameters of
the system, determine the two predetermined values of flow rate,
mentioned above, about which the electronic flow control 70 will
react to generate an output signal to send to the vent valve 120.
In addition, there is a sensitivity setting on the electronic flow
control 70 which regulates the response time of the electronic flow
control 70 to signals received form the flow transducer 60.
Most of the controls which are available to the surgeon and which
are necessary to understand the inventive aspects of the system
have already been described above. Decisions as to when to change
one of the settings are in the complete discretion of the surgeon
and determined in part by his operating techniques which need not
be discussed for purposes of describing the invention.
The main and most serious operating problem which the surgeon must
contend with is when a particle occludes the tip 23 such that the
suspension is unable to leave the enclosed operative site. Since
the pump 110 continues to operate, the vacuum in the main suction
line 58 will tend to increase. The surgeon will become aware of
such a condition almost instantaneously and will handle the
handpiece and/or ultrasonic controls in such a manner as to break
apart the occlusion. At the moment the occlusion clears the tip
there would be a tendency for the fluid and/or suspension within
the enclosed operative site to rush into the main suction line 58
to fill the vacuum created therein. This imbalance of pressures
during the occlusion, between the enclosed operative site and the
main suction line 58, is especially critical since the volume of
the enclosed operative site is exceedingly small as compared to the
volume of the main suction line 58. If the increased flow from the
enclosed operative site to the main suction line 58 is allowed to
continue for too long a period of time (measured in milliseconds)
it is possible that the entire contents of the enclosed operative
site, including parts which are not meant to be disturbed, will be
forced against the handpiece tip 23 and damaged. In the case of the
human eye there is a further risk that the entire anterior chamber
45 would collapse. Any increased flow at the handpiece tip 23 will
be immediately sensed at the flow transducer 60, since the average
time for an occlusion is very small and there is a column of liquid
between the handpiece tip 23 and the flow transducer 60. The flow
transducer which is continually sensing the flow, will send a
signal to the electronic flow control 70 proportional to he higher
rate for flow. Since the electronic flow control 70 has been
electronically programmed to react to certain changes in he flow
signals, an output signal will be sent to the vent valve 120 to
vent the main suction line 58 to atmosphere and reduce the vacuum
in said line. Depending upon whether the condition is corrected
after one venting, the signals from the flow transducer 60 may
cause the electronic flow control 70 to send another output signal
to the vent valve 120. This could be repeated several times until
there is an equilibrium in the flow.
It will be apparent from the foregoing, that a novel improved flow
control system for the removal of unwanted material from an
enclosed operative site in which it is very critical to maintain a
pressure within a certain range, has been disclosed. It is also
recognized that many variations of the particular system disclosed
herein will occur to those skilled in the art, without departing
from the spirit of the invention. Accordingly, the invention is to
be deemed limited only by the scope of the appended claims .
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