U.S. patent number 3,589,363 [Application Number 04/655,790] was granted by the patent office on 1971-06-29 for material removal apparatus and method employing high frequency vibrations.
This patent grant is currently assigned to Cavitron Corporation. Invention is credited to Anton Banko, Charles D. Kelman.
United States Patent |
3,589,363 |
Banko , et al. |
June 29, 1971 |
MATERIAL REMOVAL APPARATUS AND METHOD EMPLOYING HIGH FREQUENCY
VIBRATIONS
Abstract
An instrument for breaking apart and removal of unwanted
material, especially suitable for surgical operations such cataract
removal, including a handheld instrument having an operative tip
vibrating at a frequency in the ultrasonic range with an amplitude
controllable up to several thousandths of an inch. The operative
tip is itself hollow and is in turn surrounded by a tubular sleeve
to form an annular passage. The handpiece includes transducer means
for converting a high frequency alternating current into mechanical
vibrations and an impedance transformer for coupling these
vibrations to the operative tips. Connections are also provided on
the handpiece to a source of treatment fluid and a pump. The
treatment fluid may be coupled to either the hollow interior of the
tool or the surrounding annular passage, while the pump is coupled
to the other. During use, the vibration of the operative tip
against the tissue to be removed causes the latter to break apart
into small particles which are then dispersed in the fluid flowing
over the operative region. Concurrently, the pump withdraws the
suspension of the tissue particles in the fluid from the operative
site. The fluid flow must be regulated so as to control the
pressure within limits at the operative site. The instrument is
thus suitable for removing tissue from an enclosed area whereby the
opening to permit access to the tissue to be removed need only be
large enough to admit the tip of the operative tool.
Inventors: |
Banko; Anton (Brooklyn, NY),
Kelman; Charles D. (New York, NY) |
Assignee: |
Cavitron Corporation (Long
Island City, NY)
|
Family
ID: |
24630361 |
Appl.
No.: |
04/655,790 |
Filed: |
July 25, 1967 |
Current U.S.
Class: |
604/22; 604/27;
606/169; 606/128; 604/8; 604/28 |
Current CPC
Class: |
A61F
9/00745 (20130101); A61M 1/774 (20210501); A61B
2017/320084 (20130101); A61B 2017/320073 (20170801); A61B
2017/32007 (20170801); A61B 2017/320089 (20170801); A61B
2017/320078 (20170801); A61B 2017/320075 (20170801) |
Current International
Class: |
A61B
17/32 (20060101); A61F 9/007 (20060101); A61M
1/00 (20060101); A61m 001/0003 () |
Field of
Search: |
;128/24,303,276,278,240,241 ;32/58 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
1,429,637 |
|
Jan 1966 |
|
FR |
|
790,277 |
|
Feb 1958 |
|
GB |
|
415,949 |
|
Jan 1967 |
|
CH |
|
Primary Examiner: Trapp; L. W.
Claims
We claim:
1. Apparatus for the breaking apart and removal of animal tissue
from an enclosed area, an elongated working tip adapted to have one
end placed directly against the tissue and capable of supporting
ultrasonic vibrations, means for applying ultrasonic vibrations of
variable amplitude and duration to said working tip, means for
supplying a treatment fluid to bathe said tissue in the region
adjacent said working tip, and pumping means adjacent said working
tip for withdrawing the suspension of particles of said tissue of
said fluid resulting from ultrasonic vibration of said working
tip.
2. Apparatus for the breaking apart and removal of animal tissue
and the like comprising, an elongated, hollow working tip adapted
to have one end placed against the tissue to be removed and capable
of supporting ultrasonic vibrations, means for applying ultrasonic
vibrations to said working tip, means including a tubular sleeve
surrounding a portion of said working tip for providing a first
fluid passage between said tip and a point remote therefrom, means
coupled to said tip for providing a second fluid passage between
the hollow interior of said tip and a point remote therefrom, means
for supplying a fluid to one of said passages and means for
applying a suction force to the other of s aid passages.
3. A surgical instrument adapted to be held in the hand and moved
freely during operative use comprising, a casing of size and
configuration comfortable to the hand, transducer means within said
casing for generating high frequency mechanical vibrations upon
excitation with a high frequency alternating current electrical
signal, an operative tool external of said casing and coupled to
said transducer means to be vibrated thereby, a first fluid passage
extending through said casing and in surrounding relation to at
least a portion of said operative tool, and a second passage formed
in part internally of said operative tool and extending into said
casing, one of said passages being adapted to conduct a fluid to
said operative tool and the other of said passages being adapted to
withdraw fluid from the region adjacent said operative tool.
4. Apparatus according to claim 3 above wherein said operative tool
is elongated and formed with an axial bore providing a part of said
passage.
5. Apparatus according to claim 3 above wherein said casing
includes an extension surrounding and spaced from the peripheral
surface of a portion of said tool, the space between the inner
surface of said casing extension and said peripheral surface of
said took providing a part of said first passage.
6. Apparatus according to claim 3 wherein said transducer means
includes an acoustic impedance transformer having a relatively
massive input section and a relatively slender output section, said
output section extending within said casing extension and being
coupled at its free end to said tool, said output section having a
cross-sectional area smaller than the internal cross-sectional area
of said casing extension, the spacing therebetween forming a
continuation of said first passage, said transformer further having
an axial bore extending from the free end of said output section to
a point within said input section, and a radial bore from said
axial bore to the periphery of said input section, said axial and
radial bores forming a continuation of said second passage.
7. Apparatus according to claim 6 above further comprising a pair
of spaced-apart resilient sealing means around said input section
of said transformer within said casing, each of said sealing means
providing a circumferential fluidtight seal between said input
section and said casing, the peripheral opening of said radial bore
being between said sealing means.
8. Apparatus according to claim 6 above further comprising a first
opening in said casing located between said sealing means, a second
opening in said casing located between said casing extension and
the sealing means closest to the output section of said
transformer, and means mounted exteriorly of said casing adjacent
each of said openings adapted to be connected to a fluid
conduit.
9. A surgical instrument for breaking apart and removing unwanted
material comprising, a handpiece including transducer means for
converting high frequency alternating current into high frequency
mechanical vibrations, an operative tip coupled to said transducer
means to be vibrated thereby, said tip having an axial bore
therethrough defining a first passage sleeve means surrounding and
spaced from said tip defining a second passage, a source of high
frequency alternating current coupled to said transducer, a source
of treatment fluid coupled to one of said passages, pumping means
coupled to the other passage for withdrawing a suspension of
unwanted material in said treatment fluid, and switch means for
controlling the application of said alternating current and the
suction force provided by said pumping means to said handpiece.
10. The apparatus of claim 9 further comprising valve means
interposed between said pumping means and said handpiece, and
control means for said valve means for selectively coupling the
axial bore in said tip to said pumping means or to atmospheric
pressure.
11. The apparatus of claim 10 wherein said switch means includes a
control member selectively movable between a first position in
which no alternating current is supplied to said transducer means
and said valve control means couples the axial bore in said tip to
atmospheric pressure, a second position in which no alternating
current is supplied to said transducer means and said valve control
means couples the axial bore in said tip to said pumping means, and
a third position in which alternating current is supplied to said
transducer means and said valve control means couples the axial
bore in said tip to said pumping means.
12. The apparatus of claim 9 wherein said sleeve means includes a
readily removable sheath extending to a point closely adjacent the
free end of said operative said sheath being formed of a relatively
hard, heat resistant, plastic material.
13. The apparatus of claim 3 wherein said casing is formed of a
material providing a magnetic and electrical shield for the
components enclosed therein.
14. The apparatus of claim 9 wherein said source of fluid includes
control means for maintaining the pressure of said fluid at a level
such that an equilibrium condition between supply and removal of
fluid at the operative site may be maintained.
15. Method for the breaking apart and removal of a cohesive mass of
unwanted material from an enclosed area comprising the simultaneous
steps of, applying high frequency vibrations directly to the
unwanted material to reduce said mass of material to small
particles, bathing the material in the region in which said
vibrations are applies with a treatment fluid, and withdrawing the
resulting suspension of particles in said treatment fluid.
16. Method for the breaking apart and removal of animal tissue and
the like from an enclosed area, employing an elongated working tip
comprising the simultaneous steps of, applying ultrasonic
vibrations of variable amplitude and duration to said working tip
in contact with said tissue, supplying a treatment fluid to bathe
said tissue in the region adjacent said working tip, and
withdrawing the suspension of particles of said tissue in said
fluid so that the pressure within the enclosed area is controlled.
Description
The present invention relates to material removal devices and
methods, and more particularly to an instrument having a working
operative tip vibrating at high frequencies and with minute
amplitudes for breaking apart and removing material from relatively
inaccessible places and techniques for its use. Although by no
means limited thereto, the present apparatus is of particular
advantage when employed as a surgical instrument for breaking apart
and the removal of unwanted tissue.
Vibratory assemblies for the cutting of material have been in use
for some time in a wide number of applications. One form of such
apparatus employs a slurry formed of particles of abrasive material
in a liquid medium in conjunction with an ultrasonically vibrating
tool, whereby the vibratory energy imparted to the abrasive
particles in the slurry hurl them against the surface to be cut
with tremendous accelerations, thereby literally chipping away the
material. This technique has been applied with great success to a
wide variety of uses, particularly with respect to industrial
machine tools.
However, this type of ultrasonic vibratory assembly is ineffective
when applied to yielding materials and furthermore, requires a
fairly open site whereby the interposition of the slurry between
the vibrating tool tip and the work surface can be maintained at
all times during the procedure. Moreover, separate means are
required for the collection and removal of the spent slurry and
debris, and the workpiece generally requires a flushing or washing
to clean up the residual abrasive particles tending to adhere to
it. U.S. Pats. Nos. 3,075,288, 3,076,904 and 3,213,537 involve high
frequency vibratory instruments for particular use in the dental
field. The instruments described in these patents do not
necessarily require a source of abrasive particles, as described
above in respect to industrial equipment. Also, these dental
instruments do not have any means for removal of the particles
created as a result of the high frequency vibrations, hence would
be entirely inapplicable for use in inaccessible places.
The instrument described herein thus lends itself to the
performance of delicate surgical procedures in extremely limited
areas. One such surgical procedure, for which the instrument has
proven especially effective, is the removal of cataracts from the
eye. A cataract operation requires total removal of the clouded
lens which is usually accomplished by a 180.degree. incision in the
cornea, which is then lifted up to remove the clouded lens in one
piece. The inventive instrument of this application obviates the
need for such an incision requiring only one incision in the form
of a small aperture to allow the operative end of the instrument to
be inserted within the eye.
The primary object of the present invention is to provide a
vibratory instrument and method which are effective to break apart
and remove soft, yielding material without the use of an auxiliary
cutting medium and which is particularly adapted for use in
restricted, enclosed sites, such as are encountered in surgical
procedures.
It is a further object of the present invention to provide a
vibratory instrument including a portion readily held and
controlled by the human hand which is particularly adapted for use
in surgical procedures.
Still another object of the present invention is to provide an
instrument including a handpiece having an operative tip capable of
vibrating at ultrasonic frequencies with minute amplitudes and
having both a source of fluid and a pumping line adjacent its
working end, whereby particles of the material to be removed are
dispersed within the fluid and withdrawn from the operative site
through the pumping line as they are produced so that further
cleaning is unnecessary.
Another object of the present invention is to provide suitable
power and fluid supplies and pumping means for use with such a
handpiece, together with switch means for their control.
A further object of the present invention is to provide various
operative tip configurations for use with such a handpiece whereby
removal of materials from relatively inaccessible locations is
facilitated.
Briefly, the present invention comprises an apparatus having a
casing in which is mounted a vibratory assembly for converting
electrical energy into high frequency mechanical vibrations which
are used to break apart the unwanted tissue. Within said casing
there is also a first passage for carrying a treatment fluid to the
region where the vibrations are applied and a second passage for
carrying a suspension of unwanted material in said treatment fluid
away from said region which constitutes the above-mentioned
inaccessible place. The apparatus also includes a means for
supplying electrical energy to said vibratory assembly for the
energization thereof and a means for supplying the treatment of
fluid to said first passage and a means of withdrawing said
suspension from said second passage.
More specifically, the casing is adapted to be held in the hand,
and the vibratory assembly includes a transducer, such as of the
magnetostrictive or piezoelectric type, a removable operative tip
and a connecting body in the form of an acoustic impedance
transformer for supporting the operative tip and coupling the high
frequency vibrations thereto.
The requisite electrical power together with a supply of coolant
for the transducer is connected to the housing at the transducer
end. A supply of treatment fluid, such as a liquid providing a
dispersion medium for the particles to be removed, is coupled
through a first passage provided in the housing to an outlet
adjacent the operative tip. A source of suction, provided by a
suitable pumping means, is coupled via a second passage within the
housing to a point adjacent the operative tip.
In using the instrument, alternating electrical energy is applied
to the transducer to set the operative tip in vibratory motion. As
the operative tip is applied to the material, the region adjacent
the operative site is bathed or flooded with the treatment fluid
while the pumping means is activated to withdraw fluid with
suspended particles therein from the region.
The high frequency action of the small area output end of the
operative tool tip against the material to be removed rapidly
breaks it apart into tiny particles, dispersion of which in the
fluid medium is enhanced by the vibratory forces engendered in the
medium. The pumping means is then effective to withdraw the
resultant suspension from the region of operation. The material to
be removed is not only broken apart into small particles, but
completely withdrawn from its original location. No subsequent
flushing or aspiration procedures are necessary.
In order to keep the incision into the cornea as small as possible,
the operative tip has a bore through its center forming a part of
one of the passages and there is a tubular sleeve coupled to the
casing, surrounding a portion of the operative tip to form an
annular space thereabout which is part of the other of said
passages.
In order to simplify the problem of changing the operative tips
during an operation, the front portion of the casing, referred to
as a tubular sleeve, is readily removable to provide access to the
operative tip which is also removable from the remaining portion of
the vibratory assembly. This tubular sleeve includes a sheath which
is composed of a plastic material. Since this sheath is quite small
in diameter, in order to minimize the size of the incision, it
would be very difficult to manufacture it from any metallic
substance and maintain the proper tolerances to provide for the
annular space between it and the operative tip. Also, the
resiliency of plastic is necessary to avoid any substantial
dampening effect on the vibratory assembly should the sheath
contact the operative tip. The heat resistant nature of the plastic
material also avoids the transmission of any heat to the cornea
from the sheath.
For proper operation of the instrument it is necessary to have
certain valve and switch means for selectively operating the source
of electrical energy, withdrawal means and a line to atmospheric
pressure. This is particularly important with respect to an
operation in the eye, since it is extremely important to be able to
maintain the fluid pressure within the eye within certain
limits.
Finally, the vibratory assembly must be supported in some manner
within the casing and this is effected by the use of resilient
sealing means, an example of which are rubber O-rings. These
sealing means serve the dual purpose of supporting the vibratory
assembly at approximately a node of longitudinal motion so as to
have a minimum effect on dampening the motion and also serve to
define one of the fluid passages.
The foregoing and other objects, features and advantages of the
invention will become apparent from the following more detailed
description thereof when taken in conjunction with the accompanying
drawings, in which:
FIG. 1 is a pictorial representation of the entire instrument of
the invention showing, in perspective, the handpiece and the
supporting equipment;
FIG. 2 is an enlarged pictorial representation of the tool tip
shown in use, to aid in explaining its action;
FIG. 3 is a view, mostly in cross section, of the handpiece of the
invention showing its internal construction;
FIG. 3A is an enlarged cross-sectional view of the tip end of the
handpiece of FIG. 3;
FIG. 4 is an enlarged pictorial representation of the top of the
handpiece showing the use of the instrument in cataract
removal;
FIGS. 5A through 5I show various forms of operative tips for use
with the instrument; and
FIG. 6 is a schematic diagram of the foot switch control means for
the oscillator and pump valves.
In the ensuing detailed description, the invention will be
described in terms of its use as a surgical instrument,
particularly as applied to cataract removal. However, it will be
understood that the principles of the invention are not so
limiting, and the apparatus described is capable of a wide variety
of material breaking and removal applications, within and outside
the medical field.
Turning now to FIG. 1, the elements of the instrument of the
invention include a handpiece indicated generally at 10, which is
of a size and weight as to be comfortably held in the hand and
easily manipulated by the user. As will be described in connection
with FIG. 3, the handpiece 10 includes within its outer housing or
casing, transducer means for converting high frequency electrical
energy into mechanical vibrations of high frequency and small
amplitude. The requisite high frequency alternating current
electrical energy is supplied by a conventional oscillator included
in the unit indicated generally at 12. Insofar as ability to
perform tissue removal is concerned a wide range of frequencies is
suitable, for example from 1,000 to 100,000 cycles per second.
However, a convenient choice of frequency has been found to be
approximately 25,000 cps which permits optimum selection of
handpiece components, both with respect to overall size and
effectiveness, and also is above the range of human hearing,
eliminating annoying audible effects obtained at lower
frequencies.
The output of the oscillator in unit 12 is connected by a pair of
leads enclosed within the conduit 14 and coupled through the end of
the handpiece remote from the operative tip. As indicated on the
face of the unit 12, the oscillator is provided with suitable
frequency and amplitude controls, whereby the precise frequency of
operation may be tuned over a range and the amplitude of the
electrical signals also may be varied. These controls enable tuning
of the instrument to resonance and adjustment of the vibration
amplitude of the operative tip, in accordance with the needs of the
user.
The unit 12 also provides a source of cooling water for the
handpiece which ordinarily is required to carry away the heat
generated by the electrical-to-mechanical energy conversion
occurring in the handpiece. For this purpose, the conduit 14 also
carries a pair of flexible tubes, one for carrying the coolant into
the handpiece end and the other for withdrawing the coolant
therefrom. This provides a circulating system for maintaining the
temperature of the handpiece at comfortable levels. Unit 12, as
illustrated, is provided with a water control valve for adjusting
the cooling flow. The coolant may be obtained from a convenient tap
or may be incorporated in a closed circulation system having a
small pump and a cooling system for the coolant returned from the
handpiece.
The supporting equipment for the handpiece further includes a pump
16 (to be referred to as a withdrawal means) and a treatment fluid
supply 20. The pump is coupled via conduit 18 and through an
opening in the housing of the handpiece to the interior thereof. In
addition to providing a source of suction force for the withdrawal
of unwanted particles suspended in the treatment fluid, the pump
includes valve means whereby the conduit 18 may be selectively
coupled to the pump or opened to atmospheric pressure.
The treatment fluid supply 20, which may include a reservoir of a
premixed solution of appropriate type and a suitable pump, or
mixing means whereby the required solution is prepared on a
continuous basis, is connected through conduit 22 and into the
interior of the housing of the handpiece. As will be described in
greater detail hereinafter, the handpiece includes internal fluid
passages coupled to the conduits 18 and 22 whereby, at the
operative tip of the instrument, there may be provided both a flow
of treatment fluid and a withdrawal of unwanted particles suspended
in the treatment fluid.
A switch 24 is provided to enable control of the oscillator and
pump during manipulation of the handpiece by the surgeon. The
switch 24 may be of any convenient type, preferably resting on the
floor and including a control lever 25 adapted to be actuated by
the foot selectively between several positions. The switch is
coupled via conductors 26 to the oscillator housing 12 and the
vacuum pump 16 to control the components thereof, as will be
described more fully hereinafter.
The manner in which the instrument is used for tissue removal is
illustrated in FIG. 2. In the drawing, 32 indicates a cohesive mass
(as distinguished from a collection of discrete particles) of
undesired tissue located within a region of healthy tissue 30 below
the skin 34. To remove the tissue 32 with the present instrument, a
small surgical incision 36 is made through the skin adjacent the
mass 32 to enable the operative tip of the handpiece 10 to reach
the tissue mass 32. As the tip of the handpiece 10 is inserted
through the incision 36 and into contact with the unwanted tissue,
the surgeon actuates the foot switch 24 to apply alternating
current power to the instrument to set the tip into vibration and
also to actuate the pump 16.
At the same time, the treatment fluid supply is turned on, at
controlled pressure, so that at the operative tip of the tool which
is brought into contact with the mass 32, three conditions
simultaneously obtain. Firstly, the operative tip vibrates at a
high frequency rate and with small amplitude against the tissue
mass 32 and in the process breaks it apart into minute particles.
Concurrently, the treatment fluid supply, which preferably is a
solution compatible with the animal tissue being treated (such as
saline), floods or bathes the region at the tip end which is being
subjected to the vibratory action. Finally, the suction source at
the operative tip simultaneously withdraws from the operative site
the resultant suspension of the small particles of removed tissue
in the treatment fluid bathing the area. The unwanted tissue thus
separated from the host body is removed as it is broken apart and,
at the same time, leakage of the treatment fluid outside of the
operative site is minimized. An equilibrium condition thus exists
at the operative site between the treatment fluid, the withdrawal
means, and the small leakage.
In employing the instrument as shown in FIG. 2, the surgeon
manipulates the handpiece 10 until all of the unwanted tissue has
been broken apart and removed from the operative site. If
necessary, additional small incisions 36 may be made at various
other surface points to permit ready access to the mass of unwanted
tissue. However, each of these incisions need be only sufficiently
large to admit the slender operative tip of the instrument. This
reduces trauma and speeds recovery time, as compared to a massive
surgical excision by the usual procedures.
Although the exact mechanism occurring at the working end of the
operative tip, which results in breaking apart of the tissue mass
into minute particles, is not fully understood at present, it is
believed to be a composite of a cutting action by the relatively
sharp tip and a fracturing resulting from the large number of
impacts of the vibrating tip. Regardless of precisely how the
tissue is fragmented, it has been found that the instrument of the
invention effectively breaks apart tissue into minute particles,
sufficiently small to pass readily through an opening in the
operative tip less than 1 millimeter in diameter.
The handpiece itself is shown in cross section in FIGS. 3 and 3A.
Substantially all of the operative parts of the handpiece are
enclosed within a casing indicated at 40, which includes a
generally tubular barrel section 40a, a smaller diameter extension
section 40b threaded onto the forward end of the barrel 40a, a
forward end cap 40c having a small diameter tubular portion
extending therefrom (see FIG. 3A) threadedly engaging the forward
end of extension 40b, and a rear closure 40d threadedly engaging
the rear portion of the barrel 40a. Preferably, all of the portions
of the casing 40 are made of a metal such as stainless steel, which
is sterilizable and which also provides shielding for the
electrical and magnetic components within the handpiece.
The vibratory assembly contained within the casing 40 is composed
of a transducer portion 42 and a connecting body 46, the latter
preferably in the form of an acoustic impedance transformer. The
transducer element 42 may be of any suitable type capable of
converting high frequency alternating current signals into
corresponding longitudinal mechanism vibrations. In the embodiment
illustrated, the transducer is composed of a stack of thin sheets
of magnetostrictive material such as nickel, Permendur, or other
similar material, insulated from each other and firmly secured
together such as by brazing at the ends. As shown, the stack is
divided by a lengthwise elongated opening effectively separating
the stack into two separate vibratory sections, with the coil 44
wound about each section or leg separately, in such fashion as to
produce in phase vibration in both legs.
The forward end of the stack 42 is coupled, such as by a threaded
connection as shown or by a permanent bond, to the input end of the
connecting body 46. Preferably, a washer 43 is provided between the
end of the stack and the input surface of the member 46 to render
the transmission of vibratory energy to the member 46 more
effective.
As indicated above, the connecting body 46 preferably is in the
form of an acoustic impedance transformer whereby the amplitude of
the longitudinal vibrations induced in the stack 42 may be
increased for application to the operative tip of the handpiece.
For this purpose, the member 46 may be of the type shown in U.S.
Pat. No. 25,033, assigned to the present assignee, formed of a
single piece of vibration transmitting material such as Monel
metal, having a relatively massive input section 46a and a
relatively slender output section 46b, with a tapered transition
region 46c. As described in the aforementioned reissue patent,
maximum amplification of longitudinal vibrations in such a member
occurs when both the input and output sections of the transformer
are equal in length to one-fourth of the wavelength in the material
at the frequency of vibration and each of said sections is
substantially uniform along its length in cross-sectional area.
However, in many applications, including use in surgical procedures
such as described herein, sufficient amplitude of vibration may be
obtained under less than maximum amplitude conditions. Accordingly,
it will be understood that a relatively wide variation in
dimensioning of the impedance transformer 46 is permissible to
allow the instrument to perform its intended function effectively.
In fact, many different types of connecting bodies may be
employed.
As described in the aforementioned patents of the present assignee,
optimum energy conversion in the magnetostrictive transducer 42 is
obtained when the longitudinal dimension of the stack is equal to a
half wavelength in the material at the applied driving frequency.
Considering, then, the overall vibrating structure consisting of
the stack 42 and the impedance transformer 46, it will be seen
that, ideally, the combined length would be equal to a full
wavelength at the operating frequency, with each of the stack and
transformer being equal to a half wavelength. This would place
loops of motion at the free ends of the stack and transformer, as
well as the juncture of the two components, where a minimum stress
point would therefore occur.
At the same time, nodes of longitudinal motion would occur
approximately midway along the length of the stack 42 and
approximately at the junction of the input section 46a and output
section 46b of the transformer. The effects of the high stresses at
the junction are minimized by providing the tapered transition
46c.
As described in the aforesaid patents, support of such a vibratory
structure is best achieved by mounting means located approximately
at a node of longitudinal motion whereby minimum damping of such
motion results. In FIG. 3, such mounting means are provided in the
form of a pair of resilient rings, generally referred to as "O"
rings, located in a pair of spaced grooves extending
circumferentially around the input section 46a of the transformer,
as close as possible to the transition region where the nodal plane
would be located. The rings 48 and 50 are of such diameter that
they effect a fluidtight seal between the surface of the
transformer input section 46a and the inner wall of the housing
barrel 40a.
In addition to the spaced sealing rings 48 and 50, a plurality of
screws 52 are provided angularly disposed about the axis of the
casing, for the purpose of preventing longitudinal or rotational
movement of the vibratory structure within the casing and also for
radially centering the vibratory structure within the casing. By
adjusting the several screws, concentricity of the interior
elements of the handpiece and the casing sections may be
obtained.
The sealing rings 48 and 50 divide the interior volume of the
housing 40 into three independent fluid chambers. The ring 48 in
conjunction with the end closure means to be described hereinafter
will form a first chamber in which are disposed the
magnetostrictive stack 42 and a portion of the transformer input
section 46a. An annular chamber of relatively short axial dimension
is formed between the two O-rings 48 and 50, and a third chamber is
formed forwardly of the ring 50 including the free space within the
casing extension 40b.
The rear portion of the casing barrel 40 is sealed off by means of
a grommet 55 which is press fitted into the end of the barrel to
form a watertight seal therewith. The grommet is provided with
openings through which the electrical leads 45 pass from the
conduit 14 to the coil 44. In addition, a coolant fluid inlet tube
54 passes through the grommet 52 and extends within the barrel 40a
to a point adjacent the forward end of the stack 42. Fluid outlet
tube 56 is also passed through the grommet 52 and into the conduit
14 along with the tube 54. The cooling water supply continually
flows into the chamber enclosing the magnetostrictive element from
the tube 54, and is withdrawn through the outlet tube 56 after
passing over the heat producing elements. It will be understood
that the leads 45 and conduits 54 and 56 pass through the grommet
52 in fluid tight relationship.
To provide strain relief for the conduit 14 and minimize
entanglement, a wire coil 15 may be wrapped around the portion of
the conduit 14 adjacent the handpiece, in place of the plastic
tubing enclosing the remainder of the conduit. The coil 15 engages
a helical groove provided internally of a retaining element 41. The
latter element is compressed about the coil 15 and firmly retained
against movement by the threaded cap 40d.
The impedance transformer 46 is provided with an axial bore 47
extending from the free or forward end of the output section 46b
and into the input section 46a, to a point between the two sealing
rings 48, 50. A radial bore 47a connects the bore 47 to the
periphery of the transformer 46 and into the annular chamber
between the sealing rings. Nipple 56 is connected to the periphery
of the handpiece barrel 40a and is provided with an internal bore
extending through the casing and communicating with the annular
chamber between the rings 48 and 50 and thus with the bore 47 via
the radial bore 47a.
A second nipple 58 is connected to the casing extension 40b at a
point near its threaded coupling to the barrel 40a. The latter
nipple includes an internal passage communicating with the annular
chamber extending forwardly of the sealing ring 50 and including
the space between the impedance transformer 46 and the inner walls
of the casing sections. As shown best in FIG. 3A, this latter
chamber extends past the free end of the output section of the
connecting body 46b and through the cap 40c.
The operative tool or tip which actually comes into contact with
the material to be broken apart and removed is designated by the
numeral 60. Referring to FIG. 5A, the tip 60 is elongated and
provided with a thickened shank portion 60a which preferably is
formed with at least a pair of flats to accommodate a wrench for
tightening. A threaded connection portion 60d is formed integrally
with the base portion 60a, and a washer 60c, of efficient
vibration-transmitting material, is disposed adjacent the shoulder
between the portion 60a and 60b. The other end of the tip 60 is
shaped in a manner dependent upon the particular type of material
or tissue to be broken apart and removed and the shape of the
portion to be removed or its surrounding material. In FIG. 5A an
acute-angled taper is provided to leave a relatively sharp, rounded
edge 60d. An axial bore 60e extends completely through the tip 60
to provide a fluid passage from threaded end 60b to the outer or
working end of the tip.
Referring back now to FIG. 3A, the bore 47 in the transformer 46 is
provided at the free end of the output section with internal
threads adapted to receive the threaded portion 60b of the tip 60.
To attach the tip 60, or to replace one already in position, the
end cap 40c is threadedly disengaged from the casing extension 40b
and slid backover and away from the tip 60. A small wrench may be
used to engage the flats on the base section 60a to remove a tip
already in place or to snugly insert a new tip. The end cap 40c is
then replaced and the tool is assembled for use.
The operative tip 60, being firmly coupled to the output end of the
impedance transformer 46, will be longitudinally vibrated thereby
at the operating frequency and essentially with the amplitude
available at the end of the output section 46b. The operative tip
60 preferably is formed of an extremely hard, sterilizable
material, such as titanium, and for most surgical applications is
made of extremely small dimension. For example, in the instrument
as used for cataract removal operations, the operative tip had an
outside diameter of approximately 1 millimeter. Since this is the
only portion of the instrument that is brought into contact with
the tissue to be broken apart and removed, it will be evident that
only a very short incision need to made in the outer surface to
permit access of the tip.
Where the material to be broken apart and removed is relatively
deep below the surface, it is undesirable for the shank of the
operating tip to be brought into contact with the surrounding
tissue, especially if that tissue is healthy and not to be removed.
Since the tip 60 is vibrating at a high frequency, heat will be
developed due to the rubbing action and damage to delicate tissues
can result.
To avoid this possibility, a sheath 64 of a strong, heat-resistant
and inert material, such as the plastic known as "Teflon", is
provided. As shown best in FIG. 3A, the sheath 64 is provided with
an axial bore of a diameter somewhat greater than the outer
diameter of the tip 60 and has a base section with a counterbore
that snugly engages the tubular portion extending from the forward
end of the end cap 40c. The fit between the latter two parts is
made such that the sheath 64 may be secured to the end cap 40c with
manual pressure but will not shake loose under normal usage.
The barrel of the sheath 64 extends along a considerable length of
the operative tip 60 and has an outer diameter of sufficient
thickness to provide the necessary structural rigidity. Preferably,
it is slightly tapered, as shown. The annular clearance between the
inner surface of the sheath 64 and the outer surface of the
operative tip 60 serves as an extension of the fluid passage formed
between the transformer section 46b and the casing extension
40b.
As will be explained in greater detail in connection with FIG. 6,
alternating current electrical energy having a superimposed direct
voltage bias thereon is coupled from the unit 12 and via conductors
45 to the coil on the transducer 42. The vibratory structure is
thereby set into longitudinal vibration at the oscillator
frequency, with the consequent vibration of the operative tip 60.
For purposes of example, the amplitude of the alternating current
supply may be set such that the working end of the tip 60 has a
stroke amplitude of approximately 0.003 inch. At the same time, of
course, a coolant supply is circulating in the chamber housing the
transducer structure.
As the operative tip is brought into contact with the material to
be broken apart and removed, treatment fluid from the supply 20 is
provided through the conduit 22 and the nipple 58 to the passage
formed between the connecting body 46 and the casing extension 40b
and thence through the annular space between the cap 40c, sheath
64, and the tip 60. The tissue adjacent the operating tip is
thereby bathed with the treatment fluid.
The treatment fluid serves two purposes. In addition to maintaining
the operative tip relatively cool during use, thereby reducing
possible harm to healthy tissue, it provides a dispersion medium in
which particles of tissue are suspended as they are broken away
from the tissue mass. It will of course be realized that the
treatment fluid is being brought into direct contact with delicate
tissue and accordingly must be of a neutral nature. In the case of
cataract removal, for example, a balanced isotonic saline solution
is suitable for this purpose.
Withdrawal of the suspension of the tissue particles in the
treatment fluid is effected through the hollow operative tip, the
bore 47 in the transformer 46, the connecting passage 47a and
nipple 56, through the conduit 18 and to the withdrawal means, for
example a pump 16. During the operative procedure, the volume of
treatment fluid supply is controlled, along with the pump
operation, so that a proper amount of treatment fluid is maintained
at the operative site and overflow is minimized.
The use of the instrument of the invention as applied to cataract
removal is illustrated in FIG. 4. A portion of a simplified cross
section of a human eye is shown to illustrate the manner in which
the device is employed. The opaque lens or cataract which is to be
broken apart and removed to is designated by the numeral 72 and is
encased in a membrane including an outer portion 72a known as the
anterior capsule and a rear portion 72b known as the posterior
capsule. The iris is designated by the numeral 74 and the major
gel-filled portion of the eye, or vitreous, is shown at 76. The
cornea, the transparent outer surface of the eye, is shown at
70.
To avoid having to pierce or cut the iris, suitable drugs are
administered to dilate the iris to its maximum extent, so that as
much of the anterior capsule 72a is exposed as is possible. A small
incision 78 is then made in the transparent cornea fluid as far as
possible from the center of the pupil area. This incision need only
be about 1 to 3 mm. in length to provide proper access for the
operative tip of the vibratory assembly.
The anterior capsule 72a is penetrated, first, either by the
operative tip of the vibrating assembly or with a surgical
instrument. Once an opening in the anterior capsule has been made,
such as indicated in FIG. 4, the operative tip is inserted into the
body of the cataract 72, whereby the lens tissue mass is broken
apart into minute particles. During this portion of the operation,
the transducer is energized and the pump is activated to provide
suction force at the operative tip, along with a supply of
treatment fluid.
In the space of a few minutes, all of the cataract tissue 72 is
broken apart and the particles, together with the fluid in which
they are suspended, withdrawn by the instrument. Thereafter, the
remnants of the anterior capsule and the posterior capsule are
withdrawn with capsule forceps. This completes the cataract
removal. The small incision 78 is subsequently sutured to conclude
the surgical procedure. As compared to the conventional cataract
removal, which requires a 180.degree. incision around the cornea,
trauma to the patient and recovery time are substantially
reduced.
In FIG. 4, the operative tip of the vibratory assembly is
illustrated as inserted into the eye with the plastic sheath 64 in
place. As the surgeon maneuvers the instrument to reach all of the
cataract tissue, any contact that occurs between the instrument and
the other parts of the eye is on the sheath, which is not vibrating
and therefore cannot damage any of the delicate tissue. In this
instance, the sheath also serves to discharge the treatment fluid
more directly at the operative site. It will be understood of
course, that the sleeve 64 may be removed and the operative tip
employed without it where operative conditions permit.
In the cataract removal procedure, the treatment fluid supply
serves a purpose in addition to providing a dispersion medium for
the particles of unwanted tissue and a coolant for the operative
tip, by serving to maintain sufficient pressure within the anterior
chamber of the eye, between the anterior capsule 72a and the cornea
70, whereby collapse of the latter is avoided.
The operative tip 60 shown in detail in FIG. 5A is but one of a
number of different forms of operative tip that may be employed
with the instrument of the present invention. When used for
cataract removal, it will be seen that the straight tapered tip
shown in FIG. 5A will not be able to reach all of the lens tissue
within the lens membrane without incurring the danger of piercing
the vitreous. To clean out the portions of the lens tissue clinging
to relatively inaccessible corners of the lens membrane, operative
tips having other shapes are employed. Several possible
configurations for this and other purposes are shown in FIGS. 5B to
5I.
FIGS. 5B and 5C illustrate, respectively, a symmetrically straight
tapered tip end and a symmetrically rounded taper tip end. FIGS. 5D
and 5E are two views of a tip having a relatively blunt end and an
opening angled to the axis of the main portion of the tip to
provide a spoon shape. Such a tip is used to reach the inaccessible
corners of the lens capsule without risking damage to or possible
puncture of the vitreous.
FIGS. 5F and 5G and FIGS. 5H and 5I show two additional forms of
operative tips, each of which incorporates a sharp projection such
as might be used for puncturing the anterior capsule of the
eye.
The forgoing tip designs represent but a few of the many possible
variations which may be employed in the large number of tissue
breaking apart and removal applications that can be accomplished
with the present instrument.
A suitable switch control a arrangement for the oscillator and
coolant supply 12 and the pump 16 (FIG. 1) is shown in FIG. 6. The
pump 16 includes two input lines, 80 and 82, and a discharge line
92 to a drain or waste line. The pump preferably is of the
continuous acting type and therefore is either pumping fluid from a
sump or reservoir through input line 80 or from the operative site
through the handpiece and conduits 18 and 82. Control of the
conduits 80 and 82 is effected by solenoid valves 86 and 88
respectively, so that the pump is pulling fluid through one or the
other at any given time.
Under certain conditions, during the course of surgical procedures,
it may be desired not to withdraw fluid from the operative site,
but merely to maintain a static pressure condition thereat. For
this purpose, an additional conduit 84 is coupled to in the input
line 82 under control of an additional solenoid valve 90.
The switch 24, having a foot-actuated control arm 25, not only
controls the operation of the pump 16 but also the application of
energy from the oscillator in unit 12 to the coil on the handpiece
transducer. As shown in FIG. 6, the switch has three positions, A,
B, and C, the position A having a pair of spaced contacts 94, the
position B having a pair of spaced contacts 96, and position C
having two pairs of spaced contacts 98 and 100. The switch arm 25
is pivoted at one end and includes a pair of spaced conductive
segments 25a and 25b, separated by insulating material. When in
position C, as shown in the drawing, the segment 25a bridges the
contact pair 98 while the segment 25b bridges the contact pair 100.
In positions A and B, the segment 25a bridges the contact pairs 94
and 96 respectively.
A source of operating voltage 102 is coupled to one contact of each
of the contact pairs 94, 96 and 98. The other contact of contact
pair 94 is coupled to the inputs of both solenoid valves 86 and 90.
The other contacts of pairs 96 and 98 are connected in common to
the control input of solenoid valve 88. The contact pair 100
interrupts a lead from the oscillator 12 to the handpiece whereby
energy is delivered to the latter only when the segment 25b bridges
the contact 100, as shown.
The switch arm 25 is spring urged, such as by a coil spring 104, so
that its normal position is in position A, bridging contacts 94.
Each of the solenoid valves 86, 88 and 90 are normally in their
closed position, that is, with no electrical power supplied to
their control inputs, they close the channels in which they are
interposed.
With the switch are in position A, the contacts 94 are bridged,
permitting connection of the source 102 to both valves 86 and 90.
These two valves are thus opened, connecting the pump input to the
reservoir or sump and opening the conduit 18 to atmospheric
pressure. The valve 88 remains closed.
With the switch arm in position B, bridging contacts 96, valve 88
is opened while valves 86 and 90 remain closed. The pump 16 then is
coupled directly to the conduit 18 and thus provides a suction
force at the tip of the handpiece. It will be noted, that in both
positions A and B, the output of the oscillator 12 is not connected
to the handpiece and consequently, the operative tip 60 is not set
into vibratory motion.
With the switch arm in position C as shown, valve 88 is opened,
valves 86 and 90 are closed and the biassed alternating current
output of the oscillator is coupled to the handpiece. This
establishes the full operative condition of the handpiece, i.e.,
high frequency vibration of the operative tip and the establishment
of a suction force to withdraw fluid from the operative site.
During the operative procedure, control of the treatment fluid
supply will be maintained preferably by an assistant to the
operating surgeon. Depending upon his needs at the moment, the
surgeon will direct the assistant to control the pressure of the
fluid supply, between an "Off" or no supply position and a "High"
condition, under which maximum flow into the operative site is
obtained. (See FIG. 1). At the same time, the amplitude of the
oscillator output will be controlled to produce the proper stroke
amplitude at the operative tip. Adjustment of the latter is
desirable to permit both removal in gross of unwanted tissue as
well as the cleaning up of small bits of material where care must
be exercised to avoid damaging surrounding tissue.
It will be apparent from the foregoing, that a novel, improved form
of material breaking apart and removal apparatus has been
disclosed, by means of which unwanted material, such as animal
tissue, may be broken apart into minute particles and removed
rapidly and with a minimum of damage to surrounding materials. By
virtue of the controlled fluid supply and pump, material may be
removed from the operative site as it is broken apart thereby
eliminating the necessity for subsequent cleansing operations and
minimizing obscuring of the operative site during the
procedure.
It will also be recognized that many variations of the particular
apparatus disclosed will occur to those skilled in the art, without
departing from the spirit of the invention. For example, the flow
passages for the treatment fluid supply to the operative site and
the withdrawal of the suspension from the operative site may be
interchanged, such that the fluid is transmitted through the hollow
operative tip and withdrawn through the annular space between the
tip and the sleeve 64. Moreover, more sophisticated control
arrangements for the oscillator pump and treatment fluid supply may
be employed and various other tip shapes are possible, within the
teaching of the present invention. Accordingly, the invention is to
be deemed limited only by the scope of the appended claims.
* * * * *