U.S. patent number 3,618,594 [Application Number 05/025,991] was granted by the patent office on 1971-11-09 for ultrasonic apparatus for retinal reattachment.
This patent grant is currently assigned to Surgical Design Corporation. Invention is credited to Anton Banko.
United States Patent |
3,618,594 |
Banko |
November 9, 1971 |
ULTRASONIC APPARATUS FOR RETINAL REATTACHMENT
Abstract
The method and apparatus relate to performing surgical
operations on the eye in vivo, including retina reattachment by the
insertion of an ultrasonic probe within the eye.
Inventors: |
Banko; Anton (Brooklyn,
NY) |
Assignee: |
Surgical Design Corporation
(Queens, NY)
|
Family
ID: |
21829218 |
Appl.
No.: |
05/025,991 |
Filed: |
April 6, 1970 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
760003 |
Sep 16, 1968 |
3528410 |
Sep 15, 1970 |
|
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Current U.S.
Class: |
606/169;
606/107 |
Current CPC
Class: |
A61F
9/00727 (20130101) |
Current International
Class: |
A61F
9/007 (20060101); A61h 001/00 (); A61f
009/00 () |
Field of
Search: |
;128/24A,303,334R,335 |
References Cited
[Referenced By]
U.S. Patent Documents
Primary Examiner: Pace; Channing L.
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This is a division of application Ser. No. 760,003, filed Sept. 16,
1968, now Pat. No. 3,528,410, dated Sept. 15, 1970.
Claims
I claim:
1. Apparatus for reattachment of a detached retina portion to the
wall of an eye in vivo comprising
elongated means for projecting through the outer wall of the eye
and having a distal end portion for reaching a selected portion of
the interior wall of the eye,
means including at least a portion of said elongated means and the
distal end portion thereof for propagating ultrasonic vibrational
energy to said distal end portion to apply the energy to the
detched retina portion for securing the latter to the wall of the
eye,
and means cooperating with at least a portion of said elongated
means excluding said distal end portion for confining the
transmission of said energy substantially only to said detached
retina portion.
2. Apparatus as in claim 1 further comprising means for attachment
to the eye for supporting said elongated means, said supporting
means having a through passage through which said elongated means
extends, the size of said through passage and said elongated means
being as related so that the movement of said elongated means can
be controlled.
3. Apparatus as in claim 1, wherein said means for propagating
vibrational energy includes:
a. transducer means coupled to said elongated member for converting
alternating current electrical energy into mechanical vibration at
ultrasonic frequencies and
b. a vibratory element coupled to said transducer means to be set
into vibration thereby in a given direction, the output surface of
said vibratory element including the distal end portion of said
elongated means for insertion within the eye in energy-transferring
relation to the detached retina portion.
4. Apparatus as in claim 3, wherein said means for confining the
transmission of said propagated vibrational energy includes a guard
coupled to said transducer means so as to expose substantially only
the output surface thereof on the distal end portion of said
elongated means.
5. Apparatus as in claim 3, and including means for controlling the
intensity of the energy produced by said transducer means and means
for controlling the time of production of said energy.
6. Apparatus as in claim 2, and including sealing means between
said supporting means and said elongated means for propagating
ultrasonic vibrational energy for retaining the vitreous material
within the eye.
7. Apparatus as in claim 2, wherein said supporting means includes
a support member having a groove within which the wall of the eye
extends so as to obtain a fixed relation between the wall of the
eye and said supporting means.
8. Apparatus for reattachment of a detached retina portion to the
wall of an eye in vivo comprising
elongated means for projecting through the outer wall of the eye
and having a distal end portion for reaching a selected portion of
the interior wall of the eye,
means including at least a portion of said elongated means and the
distal end portion thereof for propagating ultrasonic vibrational
energy to said distal end portion to apply the energy to the
detached retina portion for securing the latter to the wall of the
eye,
and means for attachment to the eye for supporting said elongated
means, said supporting means having a through passage through which
said elongated means extends, the size of said through passage and
said elongated means being as related so that the movement of said
elongated means can be controlled.
9. Apparatus as in claim 8, and including sealing means between
said supporting means and said elongated means for propagating
vibrational energy for retaining the vitreous material within the
eye.
10. Apparatus as in claim 1 wherein said ultrasonic vibrational
energy is in the range from 10 kilohertz to 100 kilohertz.
11. Apparatus as in claim 8 wherein said ultrasonic vibrational
energy is in the range from 10 kilohertz to 100 kilohertz.
Description
In applicant's copending application Ser. No. 762,286, filed on
Sept. 16, 1968, and which entire subject matter of the copending
application is incorporated herein by reference as if fully set
forth herein, applicant discloses the method and apparatus for
forming an opening or incision in the eye and the performing of
surgical procedures.
BACKGROUND OF THE INVENTION
The present invention relates generally to improvements in surgical
procedures related to the eye, and more particularly for using
ultrasonic energy waves to perform retina reattachment and
treatment procedures.
The outstanding and unexpected results obtained by the practice of
the method and apparatus of the present invention are attained by a
series of features, steps and elements, working together in
interrelated combination, and may be applied to biological
organisms in general and particularly humans, and hence will be so
illustrated and described.
Before proceeding to the details of the invention, let us first
review briefly generally known facts of the eye and the anatomy of
the retina. The retina of the eye is attached to the underlying
choroid at the optic nerve border posteriorly and at the ora
serrata anteriorly. Between these two points it is in contact with
but not attached to the choroid. The retina covers entire inner
aspect of the eyeball posterior to the ora serrata. The ora serrata
is the junction of the retina and the ciliary body, in the average
eye it is about 8 mm. posterior to the limbus. The retina is
composed of inelastic nerve tissue, consisting of 10 distinct
different layers. Normally it is transparent; when detached it
appears gray. Most common of retina detachment is the partial
separation (detachment) of the retina from the choroid. The
superior temporal part of the retina is most commonly effected but
any part or even the entire retina may become detached.
Reattachment of the retina can be accomplished only by surgery. To
date essentially four different approaches are presently being used
on humans to obtain this reattachment. In one of these a partially
penetrating diathermy electrode is passed through the area of the
solera which corresponds to the retinal defects. The subretinal
fluid is then drained by perforating the sclera and choroid.
Drainage of the subretinal fluid is important so that the retina
can settle back against the choroid. In a few weeks a cicatrical
bond is formed; it involves the retina, choroid and sclera.
Cryosurgery is another approach used in the same way as diathermy.
The supercool probe causes a chorioretinal scar with minimal
scleral damage, making the operation less hazardous.
The photocoagulation process is one in which a small choroidal
retinal inflammatory exudate is produced by directing a strong
light from a carbon arc source through the dilated pupil. This
treatment is used in minimal detachments and postoperatively to
supplement inadequate diathermy.
Laser energy (light amplification by stimulated emission of
radiation) is a form of photocoagulation that is used less
frequently than carbon arc photocoagulation, but has been used on
humans.
The use of ultrasonic energy has also been proposed for retina
reattachment in which the energy is transmitted from the exterior
of the eye for retina reattachment. In one procedure chorioretinal
lesions were produced with a focused sound beam which entered the
eye anterior to the equator. Frequencies in the megahertz range
were used. In addition 25, 000 cycle per second energy has been
applied by pressing the tip of the probe against the sclera in the
region where a lesion on the retina is desired. At 25,000 cycles
per second chorioretinal lesions can be produced by a 1.5 mm.
diameter tip vibrating with a stroke of 50 microns (0.002) for
several seconds, scleral damage is unavoidable.
OBJECTIVES OF THE INVENTION
An object of the present invention is to provide an improved method
and apparatus for performing surgical procedures with respect to
the eye.
Another object of the present invention is to provide an improved
method and apparatus which utilizes ultrasonic energy for
performing surgical procedures.
Another object of the present invention is to provide an improved
method and apparatus for performing surgical procedures in vivo in
the eye.
Another object of the present invention is to provide an improved
method and apparatus for performing reattachment of the retina by
employing ultrasonic energy introduced within the eye in vivo.
Another object of the present invention is to provide an improved
method and apparatus using ultrasonic energy for securing together
layers of tissue in biological organisms, such as the retina to the
choroid.
Another object of the present invention is to provide specially
designed instrumentation to carry out the surgical procedures of
the present invention.
Other objects and advantages of this invention will become apparent
as the disclosure proceeds.
SUMMARY OF THE INVENTION
The present invention is directed to the treatment of the eye and
is based upon the discovery that the retina reattachment may be
accomplished by inserting an ultrasonic probe within the eye and
propagating the energy waves directly to the detached portions.
Accordingly, the front part of the ultrasonic probe is inserted
into the eye through a sclerotomy over the pars plana opposite to
the retinal defect. The sclerotomy will be bridged with a preplaced
mattress suture of which the tightening will prevent vitreous loss
during the operation. The tip of the ultrasonic probe can be
positioned in the desired region, in the proximity or adjacent to
the retina, by a micromanipulator. The amount of ultrasonic energy
emitted by the tip, vibrating at a given frequency, is proportional
to the vibratory stroke of motion and the number of cycles of
vibration (time of vibration). Both factors are precisely
controlled. The amount of ultrasonic radiation is limited to
produce small choroidal retinal inflammatory irritation, sufficient
to form a delicate weldlike bond between the retina and choroid,
but insufficient to create an explicit lesion. The sclera is not
considerably effected by this procedure.
Unlike diathermy and the cryo probe the tip of the ultrasonic probe
remains practically at the same temperature, whether it vibrates or
not, it is for this reason that any transfer of any kind of energy
practically ceases as the tip stops to vibrate.
The above-mentioned sclerotomy may be formed in accordance with
applicant's copending patent application hereinabove referred to,
and may be used for insertion of other tools and instruments beside
the ultrasonic probe. Some of which may by way of illustration, a
two-way bundle of fibers, of which one set is used for the
illumination of the interior of the eye and the other set in the
bundle is used to carry the image back to the viewer. This
arrangement enables a thorough inspection of the interior of the
eye before and after the operation.
The present invention is based on the discovery that the detached
retina portion may be joined by utilizing vibrational wave energy
that is introduced within the eye cavity in small amounts and
dosages. The joinder of the detached portion is accomplished
without necessarily employing radical surgical procedures related
to high intensity or high-power ultrasonic energy and in this
manner serves to reduce any side effects or secondary results which
would be dangerous to the patient. As is well known, by
transmitting the energy through sclera and choroid, there is a
possibility of doing damage to tissues adjacent to the probe.
Further, by introducing energy of a magnitude greater than is
required to perform the bond (because of the attenuation through
sclera and choroid), other portions of the organ may also be
adversely affected.
The present invention accomplishes the beneficial results by the
direct application of sonic, transonic or ultrasonic vibrational
wave energy directly within the eye and only to the particular
detached portion thereof at its location. In this manner the
detached portion of the retina can be completely secured in place
by the direct application of tolerable amounts of energy for short
periods of time and, in particular, times which are so short that
the heating effects normally associated with the application of
concentrated wave energy to the human body do not present a
significant problem. It has been found that the detached portions
may be joined together without any damage to sclera or other tissue
in other regions of the eye, and without introducing major amounts
of energy. Unlike in other standard procedures, the radiated energy
which has not been absorbed at the retina choroid interface to
produce the desired bond, is directed out of the eye eliminating
the possibility of adversely affecting other tissue in the eye.
In practicing the present invention, surgical procedures are
involved to expose the suitable portion of the eye, and a point of
entry is formed for the insertion of an ultrasonic probe to be
guided to the location of the detached portion in the eye in order
that the wave energy from the end of the probe can be applied
directly to the detached portion. By insertion of the probe which
enters the eye at an exposed area it can be properly controlled
with a minimum of danger to the organ. The probe is inserted either
in contact or close proximity to the area to be treated. This
permits the vibrational wave energy of the end of the probe to
propagate wave energy directly into the detached portion, thereby
providing an efficient transfer of energy into the detached portion
and its resultant joinder. The probe can be advanced such that
there is direct physical contact as well as to transmit transverse
vibration of the energy thereto.
In accordance with another feature of the invention, means for
controlling the propagation path is provided in form of a guard in
surrounding relation to the vibratory probe portion such that it
minimizes the danger of the energy being transmitted to other
portions which are not required to be treated.
BRIEF DESCRIPTION OF THE DRAWINGS
Although the characteristic features of this invention will be
particularly pointed out in the claims, the invention itself, and
the manner in which it may be made and used, may be better
understood by referring to the following description taken in
connection with the accompanying drawings forming a part hereof,
wherein like reference numerals refer to like parts throughout the
several views and in which:
FIG. 1, is a somewhat schematic view of an ultrasonic motor
generator system for driving a tool member adapted to be inserted
in the eye for performing a surgical procedure;
FIGS. 2 and 3, are enlarged schematic pictorial representations
illustrating an ultrasonically vibrating tool member for joining
detached retina portions to the wall of the eye;
FIG. 4, is a view taken along line 4-4 of FIG. 3 of a fragment of
the eye
FIG. 5, is a view similar to FIG. 2, illustrating another aspect of
the invention;
FIGS. 6 and 7, are enlarged views partly in section, illustrating
the formation of an opening through the wall of the eye; and
FIG. 8, is a view similar to FIG. 7, showing an instrument
extending within the eye for performing a surgical procedure.
DETAILED DISCUSSION OF THE DRAWINGS
Referring now to the drawings and particularly to FIG. 1 thereof,
we see the schematic representation of an eye 10 having the various
portions thereof including a retina 12, in a particular area 14
with spaced apart detached portions 16 and 18 from the choroid 20.
The area 14 is detectable in a conventional manner such that the
surgeon is aware of its location and will conduct the operation
with the intent to rejoin the detached portions, or portion, to the
choroid 20 without substantially, if at all injuring the associated
parts thereof including the sclera 22. The wall 25 is intended to
define any portion of the eye which when pierced will connect the
interior of the eye to the exterior and will generally include all,
or portions, of the retina 12, choroid 20 and sclera 22, or the
sclera 22 and ciliary body 24.
Once the partial separation, or detachment of the retina 12 from
the choroid 20 is detected, and this generally occurs with respect
to the superior temporal part of the retina which is most commonly
affected, but any part or even the entire retina may become
detached, then the reattachment of the retina can be accomplished
in accordance with the teachings of the present invention. First an
incision or opening 27 in the eye 10 to permit the insertion of a
probe 30 therethrough to reach the specific area to be treated. The
process of forming the opening 27, is discussed in greater detail
in applicant's copending patent application hereinabove referred
to, but is hereinafter described to illustrate its use with the
present invention, since it is capable of being used not only for
the reattachment of the retina but also for various other operative
procedures and uses both with the eye and other portions of the
anatomy. It is accordingly so described and intended.
Once the opening is formed the probe 30 is inserted therein such
that the tip having a distal end or vibratory surface 32, is
positioned within the vitreous material 34 contained in the eye 10
and the vibrational wave energy may be propagated through the
vitreous material 34 to obtain a joining or a bonding of the
detached portions 16 and 18 to the wall 25, such as the choroid 20
and the sclera 22. The vibrational wave energy or ultrasonic
energy, as the terms are herein used is intended to include
vibratory energy in the frequency range of from 1 kilohertz to 20
megahertz although the preferable range is generally from 10
kilohertz to 100 kilohertz.
Referring further to FIG.1, it will be seen that the apparatus or
probe 30 for ultrasonically performing surgical procedures on a
biological organism, such as a human, may include an ultrasonic
transducer or motor 35 for effecting the necessary high-frequency
vibrations of the vibratory element or tool member 36 having a
distal end or output surface 32. The ultrasonic motor 35, as
illustrated may be in the form of a driving member adapted for
being hand held as by an operator 38, and generally comprising a
tubular housing or casing 40 into which an insert unit supporting
the tool member 36 may be partially telescoped. The ultrasonic
motor 35 is energized by an oscillation generator 42, with a power
cable 44, connecting the two together. The generator is an
oscillator adapted to produce electrical energy of the desired
frequency.
The ultrasonic motor 35 may be one of a variety of
electromechanical types, such as electrodynamic, piezoelectric or
magnetostrictive. The ultrasonic motor for effecting surgical
procedures through hand-directed tools of suitable configuration,
which are readily replaceable or interchangeable with other
work-performing tools in acoustically vibrated material treating
devices, may be of the type in which each work tool member is
rigidly joined, in end-to-end relationship to a connecting body or
acoustic impedance transformer and to a transducer which may form
an insert unit or assembly which is removably supported in a
housing containing a coil in surrounding relationship to the
transducer and receiving alternating current for producing an
alternating electromagnetic field.
The transducer in the ultrasonic motor 35 is longitudinally
dimensioned so as to have lengths which are whole multiples of
half-wave lengths of the compressional waves established therein at
the frequency of the biased alternating current supplied so that
longitudinal loops of motion as indicated by arrow 45, occur with
maximum displacement at the vibratory surface 32 of the vibratory
element 36 that is rigidly connected to the insert unit. Thus, the
optimum amplitude of longitudinal vibration and hyperaccelerations
of vibratory element 36 is achieved, and such amplitude is
determined by the relationship of the masses on both sides of the
nodal region of the tool member which may be made effective to
either magnify or reduce the amplitude of the vibrations received
from the transducer.
The vibratory element 36 may be permanently attached to the
transducer, for example, by brazing, solder or the like, or the
tool may be provided with a threaded stud adapted to be screwed
into a tapped hole in the end of the transducer for effecting the
rigid connection of the tool.
The ultrasonic motor 35 in the casing 40 may include a
magnetostrictive transducer for intermittent operation, which is
composed of a stack of magnetostrictive laminations and a metallic
connecting body part of which is the vibratory element 36.
Incorporated in ultrasonic motor 35 is one or two coils, when two
coils are used one is the driving coil, and the other is the pickup
coil. The driving coil carries the DC and RF energizing currents
from the ultrasonic generator 42. The DC current provides the
magnetic biasing necessary for an efficient operation of the
magnetostrictive laminations. The RF current has generally a
sinusoidal shape, it provides the energy required to initiate and
maintain the ultrasonic vibration at the resonance of the vibratory
system. This current is generating an alternate magnetic field
which is superimposed on the biasing one. The ratio of the two
fields and their relation to saturation of the lamination is such
to provide the greater electromechanical coupling and transducer
efficiently with the smallest possible exciting power.
The pickup coil is located at one end of the stack of
magnetostrictive laminations thus sensing the variations of
strength of the magnetic field due to changing in stress in the
cross section of the magnetostrictive laminations. The variation in
field strength causes an inductive voltage as an electromotive
force for the current through a closed loop comprising the pickup
and the generator oscillator 42. The generator 42 responds to the
maximum signal which is produced at resonance, so that it will
drive the system at its momentary resonant frequency regardless of
the particular load at that time applied by the vibratory element
36 within the eye 10.
The generator 42 is provided with control means for setting the
time of duration of the emission of ultrasonic energy by adjusting
the dial 47. For power adjustment dial 49 is provided which
controls the amount of power delivered to the ultrasonic motor.
The vibratory stroke of the distal end 32 of the vibratory element
36 is controlled by manual setting of the power dial 49 on the
generator. The time of duration of ultrasonic radiation is defined
by positioning the dial 47 on the generators front panel, and the
energy may be continuous or intermittent.
The vibratory stroke and the time of duration of vibration are the
only parameters controlling the amount and with it the effect of
ultrasonic vibration. These two parameters can be easily adjusted
very precisely, so that results can be controlled and reproduced by
setting of the control dials 49 and 47 on the generator 42.
The vibratory element 36 may be of monel and one-half wavelength
long, .tau./2, where .tau..congruent.c/f, c being the velocity of
sound in a monel rod, and f being the operating frequency. The
.tau./4 long output section has to have the minimum possible
outside diameter preferably not greater than 1.5 mm. in diameter,
sufficient only to create a relatively small inflammatory
irritation at the distal end 32. A linelike effect may be produced
by maneuvering the motor 35 to any position by movement along an
angular path as indicated by arrow 48, in such a way to guide the
tip 32 over the desired region. A small diameter at the vibratory
surface 32 is essential to be able to work through a relatively
small incision 27. In the proximity of the nodal region of the wave
guide a flangelike increase in diameter is provided for supporting
purposes.
The vibratory probe 30 is provided with means for controlling the
propagation path as by using guard means 46 that may be secured to
the casing 40 of the motor 35 in any conventional manner and which
may be in the form of a tubular member 51 mounted in coaxial
alignment with the vibratory element 36 and designed to prevent
rubbing between the vibratory element and the housing when the tip
is vibrating, thus, preventing generation of heat due to friction.
The protective tubing 51 also serves as an insulator or as a
reflector to prevent ultrasonic energy being radiated except from
the vibratory surface 32, so that the propagation path is directed
at the retina portion to be reattached. The protective tubing 51
may extend the length of the vibratory element 36 or beyond it if
desired. The guard means 46 also serves to support the front part
of the ultrasonic probe 30 when sliding axially in the supporting
means 50 positioned within the opening 27 and is easily removable
to permit the cleaning of the instrument.
The supporting means 50, as seen with respect to FIGS. 6-8, extends
through the wall 25, such as the sclera 22 and ciliary body 24 over
the most convenient region of the pars plana, and is positioned in
and tightened in the incision or opening 27 by a double mattress
suture 52. The support means 50 should have the ability to rotate
within the opening 27. To provide a seal with the protective tubing
51 and facilitate its sliding for relative axial movement the
supporting member 50 should be provided with sealing means 65,
which may be in the form of an O-ring 68 contained in seat 66, and
have a minimum outside diameter to be inserted into the incision
27, and possibly supported and rotated by a micromanipulator.
Finally the supporting member 50 should eventually provide for an
increase in volume of the vitreous cavity in order to reduce the
pressure in the eye 10 during the operation.
In performing the surgical procedure we initially form the opening
27 in the wall 25 of the eye 10, which may extend through sclera
22, choroid 20, and retina 12, or the sclera 22 and ciliary body
over the pars plana, the latter being preferred. The formation of
the opening 27 seen with respect to FIGS. 6 through 8, and is
formed by supporting means 50, which comprises a tubular body
portion 53 which may be of circular cross-sectional area so that it
may be rotatable after it is seated through the wall 25 of the eye
10, and includes the passageway 54 extending from the front end 56
to the rear end 58, which rear end has an upper annular flange 60
extending radially outwardly from the body portion 53 proximate the
upper end thereof and adapted to overlap the outer surface of the
eye 10. A lower annular flange 62 extending radially outwardly from
the body portion 53 proximate the lower end thereof is adapted to
extend over the inner surface of the wall portion 25. Retaining
means 63 is defined by the spacing between the flanges and forms a
groove 64, adapted to contain the wall portion 25 of the eye 10.
The sealing means 65 provided in the passageway 54 may include a
seat 66 containing the sealing member 68 which is illustrated in
the form of an O-ring to provide the sealing engagement with any
element or instrumentation inserted within the passageway 54. Thus,
also permitting sliding engagement for relative movement with any
instrument. Due to the viscosity of the vitreous material a close
tolerance at one point in the passageway 54 with the protective
tubing 51, or other instrument, may be sufficient to provide the
sealing engagement required.
The supporting member 50 has mounted coaxially therewith cutting
means in the form of cutting element 70 which includes an enlarged
head section 72, adapted to be coupled to an instrument if desired,
and having a base section 74 extending through the passageway 54
and terminating in a cutting surface 76 of a selected
configuration. Looking means 78 is provided between the supporting
means 50 and cutting means 70 in the form of a pin 80 extending
from the base section 74 into a groove 82 contained within the
passageway 54 to prevent angular rotation between said respective
means during their insertion into the eye.
In actual practice the combined supporting means 50 and cutting
means 70 are coupled together as a unit and inserted in the
direction of arrow 84 as seen in FIG. 6, such that the cutting
surface 76 pierces the wall 25 and is moved axially forward until
the position in FIG. 7 is reached and the supporting means 50 is in
seated position and retained in place by the retaining means 63.
The contour of the cutting surface 76 being pressed into the eye 10
is of increasing cross section and designed as a conical shape
until it embraces the groove 64 of the supporting member 50. The
lower flange 62 has a rounded edge 86 and tapered front such as to
continue essentially the taper of the cutting surface 76 as it is
forced through the wall 25. Once the position in FIG. 7 is reached
the wall 25 is retained within the groove 64 and the two mattress
sutures 52 may be conveniently tightened so as to prevent any of
the vitreous material from flowing out and providing sealing
engagement between the supporting means 50 and wall 25.
The cutting element 70 can now be withdrawn, by disengaging the
locking means 78 and removing the cutting element 70 in the
direction of arrow 85, leaving the passageway 54 open between the
interior and exterior of the eye and in which case part of the
vitreous material will tend to flow therein. It is now possible to
insert through the passageway 54 different tools and instruments
which normally could be attached to a solid structure like a
micromanipulator, which will provide the stability and a supporting
point for the front of the instrument thus, relieving the strain on
the surgeon's hand. Removal of the supporting means 50 when
required, is accomplished by inserting a conically pointed rod (not
shown) instead of the cutting element 70, to engage the locking
means 78, and to minimize damage on the eye tissue during the
withdrawal of the supporting means 50, during this latter process
an additional pair of mattress sutures are to be gradually
tightened as the supporting means 50 is gradually removed from the
wall to close up the opening 27.
As discussed in applicant's copending patent application the
puncturing or cutting element 70 is a pointed two-edged knife,
designed to start an incision and enlarge it to the proper length
in the desired direction, the direction is defined by the
positioning pin 80 contained thereon. An advantage of reinserting
of a conically pointed rod into the passageway 54 before the
removal of the supporting member 50 is that it forces the vitreous
material from the passageway 54 back within to the eye. Insertion
of the rod into the eye increases the pressure in the eye, thus
reducing the clamping force around the supporting member,
facilitating its removal.
Accordingly, once the supporting member 50 is in place, as seen in
FIG. 8, guard means 46 is in sealing engagement with the O-ring 68
and the vibratory element 36 extends therethrough and as seen by
the arrow 48 the support member may be angularly tilted such that
the vibratory surface 32 as seen in FIGS. 2-5, may be properly
manipulated to the desired position for propagating the energy
waves.
Applicant has found that in accordance with the present invention
small amounts of vibrational energy can be utilized to, in a sense,
form a fusion or joinder of overlapping sections of the layers of
the wall 25 which as illustrated in FIG. 1, are generally the
retina 12, choroid 20, and sclera 22, this minimal amount of energy
with a relatively low power unit which the generator is capable of
producing which may be in the range of 2 to 100 watts, is
sufficient to obtain this joinder which may be either continuous,
or as seen in FIG. 4, a plurality of individual bonds or joinings
90 may be formed.
The probe 30 once inserted within the eye 10 as indicated in FIG.
1, is then brought into energy-transferring relationship with the
detached portions 16 and 18 in the work area 14 as by either
physical engagement of the distal end 32 therewith as seen in FIGS.
2 and 3, or in spaced apart relationship as seen in FIG. 5, with
the energy waves propagated through the vitreous material 34. As
seen with respect to FIGS. 2-4 a pattern of bonds may be formed
which include a first or outer series of bonds 90 surrounding the
respective portions 16 and 18 such that a series of tack welds
provide the necessary attachment between the retina 12 and choroid
20 and thereafter the vitreous material 34 between the retina 12
and choroid 20 may be removed by either using a tool other than the
vibratory element 36, or the vibratory element 36 may be brought
into contacting pressural relationship in the direction of arrow 91
to force the vitreous material 34 from between the portions 16 or
18 and the wall 25. In FIG. 2, one portion 16 is joined such that a
second or inner series of welds 92 is obtained immediately adjacent
the free edges of the detached portion 16 of the retinal wound.
Once this is completed on one side thereof the opposite side is
reattached as seen in FIGS. 3 and 4, such that the respective
series or sets of bonds 90 and 92 are obtained. Obviously, the
size, location and shape of each bond 90 and 92 will vary with
respect to the size, location and extent of the damage that has
taken place with respect to the detached portions 16 and 18. An end
series of bonds 96, spaced apart to form a continuous seal, as seen
in FIG. 4, may be necessary to prevent vitreous to again penetrate
between retina 12 and choroid 20. These bonds 96 may be applied at
or on the edges of the detached portions 16 and 18 of the retinal
wound.
FIG. 5, illustrates the problems being brought into engagement such
that the vibratory surface 32 is in spaced relation to the detached
portion 16 and the bond 92 is immediately formed adjacent the edge
thereof. The guard means 46 is seen extending beyond the vibratory
surface 32 of the vibratory element 36 to engage and retain the
retina portion 16 in place. The vibratory energy is applied in
direction of double headed arrow 94 and after the bonds 92 are
formed is removed in the direction of arrow 95. As seen the
vitreous material 34 is removed by engaging the end of the guard
means 46 against the detached portion 16 and moving the probe
towards the wall portion 25 to squeeze out the vitreous material
from therebetween.
The guard means 46 is held in position such that the axial outer
surface of the vibratory element 36 propagates its waves only from
the distal end 32 thereof. The guard means 46 has an extended lip
as seen in FIG. 5, such that it extends beyond the distal end 32
and the distal end is maintained in spaced relation with the waves
propagated through the vitreous material 34. If this approach is
utilized the guard means 46 acts to compress the overlapping areas
and force out the material therebetween. If desired the guard means
46 or even the vibratory element 36 can be coupled to conventional
electronic means such that the axial force applied is controlled
and the degree of pressure can be indicated exteriorally of the
human which enables the operator to know when the requisite amount
of pressure required is reached.
Depending upon the location and degree of separation the energy
level and its amount are controlled by dials 47 and 49 of generator
42 and furthermore a frequency in the range between 1,000 cycles
per second and 20,000,000 cycles per second may be used, such that
the proper vibrational pattern desired is obtained. As far as the
actual joining is concerned it is to be appreciated that a minimal
amount of energy will effect the bond which is capable of retaining
the overlapped sections of the retina 12 to the wall 25, such that
the eye 10 may thereafter function in a proper manner. By
maintaining the distal end 32 at a minimum diameter, generally in
the range of 0.010 to 0.060 inches, and by intermittently
transmitting this energy to the distal end thereof a minimal
temperature rise will occur in the tissue portions such that no
damage is noticeable. The energy is propagated generally in the
direction normal to the interface of the two layers to be joined
and although this energy is in a longitudinal mode it is
appreciated that either elliptical, flexural, torsional, or even
corkscrew motions may be propagated to form the bonds.
Many other changes could be effected in the particular
constructions, and in the methods of use and construction, and in
specific details thereof, hereinbefore set forth, without
substantially departing from the invention intended to be defined
herein, the specific description being merely of embodiments
capable of illustrating certain principles of the invention.
* * * * *