A capsulectomy apparatus which comprises a console, a handpiece and a needle. The handpiece operates from a vibrating transducer which drives a rod within the sleeve of the needle for actively engageing the anterior lens capsule which is to be severed. The head of the needle which engages and cuts the anterior lens capsule of the eye has a specific angular relationship with the rod within the needle. Also, the cutting edges and surfaces associated with the head of the needle have a specific configuration for enhancing the cutting quality of the apparatus. The needle is disposable and specifically configured to be removeably affixed to the handpiece.

FIELD OF THE INVENTION 
The present invention relates generally to ophthalmic surgery. 
Specifically, the present invention relates to an electromechanical 
membrane/tissue cutter-capsulectomy apparatus for continuously and 
smoothly severing portions of the anterior lens capsule of the human eye. 
BACKGROUND OF THE INVENTION 
With the increased rate of success of ophthalmic surgery, the need has 
grown for surgical devices and methods which further enhance surgical 
techniques. With the advent of varied and different surgical techniques, 
new devices and methods have been advocated and new successes have been 
recorded. Specifically, the need to enhance the methods and procedures for 
performing the anterior capsulectomy during extracapsular surgery have 
become critical to the success of the surgery. Numerous methods are 
currently used and numerous apparatus are currently employed. 
Many surgical and diagnostic procedures are currently being performed 
manually. In many instances, the clinician has difficulty performing the 
procedure or evaluating the condition using the manual method. 
Automation of the device goes far beyond the use of electromechanical or 
other energy forms to drive the instrument. Automation implies the 
development of a more sophisticated device that significantly improves the 
procedure as it is currently performed. 
The development of an automated device requires the use of new techniques, 
and not merely using a new device the old way. Significant patient 
benefits will result by enabling the clinician to be more effective and 
efficient. This includes: reduced trauma, better postoperative 
rehabilitation, and more quantitative results. 
The anterior capsule is a cellophane-like membrane covering the anterior 
surface of the lens. It is continuous with the posterior capsule, a 
cellophane-like membrane behind the lens. The human lens is encapsulated 
by this membrane. In order for a cataract (opacified lens) to be removed 
in an extracapsular extraction procedure, the anterior capsule must be 
opened to allow for instrumentation to enter "the bag" and removal of the 
nucleus and cortical material. Various techniques and principles have been 
devised to cut or tear the anterior capsule. For example, some well known 
techniques include the "Christmas tree," the "Beer-can," and various 
modifications of these techniques. An excellent review of the methods and 
complications can be found in Phacoemulsification and Asperation of 
Cataracts, J. M. Emery and J. H. Little, Eds., Chapter 10, (1979), C. V. 
Mosby Co. 
The anterior capsulectomy is generally recognized as the most difficult 
step in the cataract procedure. Numerous articles have appeared in Ocular 
Surgical News and Ophthalmology Times on the anterior capsulectomy 
procedure. Many surgeons have tremendous problems with the capsulectomy 
procedure even through they are quite proficient in the other steps in the 
procedure. 
A poorly performed anterior capsulectomy significantly increases the 
difficulty in performing the subsequent steps in the procedure and the 
probability of operative complications. Complications resulting from a 
poor capsulectomy include: zonular stress with subsequent breakage of the 
posterior capsule, difficulty in nucleus expression, and large capsular 
tags preventing efficient cortical removal including increased operative 
time and probability of vitreous loss. A poor capsulectomy also prevents 
placement of an intraocular lens (IOL) in the capsular bag due to 
ill-defined capsular structures. Many journal articles, some referenced 
herein, substantiate the difficulty in performing the procedures and the 
ensuing complications from a poorly performed technique. The articles also 
suggests surgical techniques to improve the results and reduce the 
difficulty in the subsequent steps. 
As a result of the difficulties and complications cited, a definitive need 
exits for a device and technique to perform an efficient, effective, and 
efficacious anterior capsulectomy. Such a device should simplify the 
procedure and enable the surgeon to perform the capsulectomy, and the 
subsequent steps, more quickly and effectively. 
Some of these prior used methods include manual and mechanical techniques 
for severing the anterior lens capsule of the eye to perform the 
capsulectomy. For example, a mechanical device was disclosed by Henry M. 
Clayman and Jean-Marie Parel in the American Intra-Ocular Implant Society 
Journal, Volume 10, Fall 1984, pp. 479-482. The Clayman/Parel paper, 
entitled "The Capusule Coupeur for Automated Anterior Capsulectomy," 
describes a mechanical automated anterior capsulectomy device. The 
Clayman/Parel device operated from a power source and provided a rotating 
cutting tip. The rotating cutting tip extended from the end of a tube and 
rotated orthogonal to the center axis of the tube. The cutting edge caused 
the incision of the anterior lens capsule of the eye. 
Additional devices are known for performing the capsulectomy. For example, 
Sharp Point, Inc. has a manual device which utilizes a rigid rod with a 
freely rotating cutting member for cutting the eye. As the cutting member 
at the end of the rod is moved in a circular path across the tissue, the 
cutting edge of the "nail-like" cutting member cuts the lens of the eye 
along the path traversed. Other manual devices are known in the art, for 
example, cystotomes and gauge vent needles. Also, an ultrasonic driven 
uptotome is known in the art. 
In all of the prior known devices, it is difficult to cleanly cut the 
capsule without leaving residual "tags" or tears in the capsule. Also, 
prior known devices either cause sufficient drag on the capsule to rock 
the nucleus of the lens or to place stress on the zonular structure. All 
of these problems tend to create undesirable foundations for intraocular 
lens placement or other surgical complications. 
It is, therefore, a feature of the present invention to provide a 
capsulectomy apparatus which facilitates a continuous smooth, curvilinear 
cut. 
Another feature of the present invention is to provide a capsulectomy 
apparatus which does not rock the nucleus of the lens. 
Yet another feature of the present invention is to provide a capsulectomy 
apparatus for facilitating a continuous, smooth, curvilinear cut of the 
anterior lens capsule while reducing zonular stress and ultimately 
eliminating zonular dialysis. 
Still another feature of the present invention is to provide a capsulectomy 
apparatus which provides a cleanly cut capsule. 
Yet still another feature of the present invention is to provide a 
capsulectomy apparatus that eliminates residual tags of the anterior 
capsule. 
A further feature of the present invention is to provide a capsulectomy 
apparatus which easily cuts any desired capsular pattern, at any location, 
and of any size. 
Yet further, an additional feature of the present invention is to provide a 
capsulectomy apparatus which provides a superior foundation for 
"in-the-bag" lens placement. 
Yet another feature of the present invention is to provide a capsulectomy 
apparatus which minimizes the shear forces associated with capsular tears. 
Yet still another feature of the present invention is to provide a 
capsulectomy apparatus which facilitates a continuous, smooth, curvilinear 
cut for the anterior capsule. 
An additional feature of the present invention is to provide a capsulectomy 
apparatus which provides a free-flowing anterior capsule button. 
Additional features and advantages of the invention will be setforth in 
part in the description which follows, and in part will become apparent 
from the description, or may be learned by practice of the invention. The 
features and advantages of the invention may be realized by means of the 
combinations and steps particularly pointed out in the appended claims. 
SUMMARY OF THE INVENTION 
To achieve the foregoing objects, features, and advantages and in 
accordance with the purpose of the invention as embodied and broadly 
described herein, a capsulectomy apparatus is provided for facilitating a 
continuous, smooth, curvilinear, stress-free, tag-free, free-floating cut 
of the anterior capsule which comprises a console for providing power for 
and control of the capulatomy apparatus, a handpiece in operative 
association with the console, and a disposable needle in direct 
association with the handpiece for entering the eye and initiating the 
capsulectomy. 
More particularly, the handpiece of the present invention utilizes a 
magnetically driven transducer for providing longitudinal movement to the 
cutting portion of the needle. The handpiece contains a driver end which 
remotely engages the magnetically driven transducer for activating a 
toggle which directly engages the cutting portion of the needle. 
The disposable needle of the present invention comprises a sleeve, a rod 
and a head having a plurality of cutting edges. The rod is driven back and 
forth or oscillated in the sleeve such that the cutting head provides a 
continuous, smooth, tag-free, free-floating clean cut of the capsule by 
the plurality of cutting edges. In one embodiment the cutting head is a 
pyramid-like configuration. The pyramid-like cutting head resembles a 
polyhedron. However, the typically planar faces of the polyhedral, 
pyramid-like structure are concaved. Preferably, the radius of curvature 
associated with the concaved surfaces of the polyhedral structure is less 
than approximately 0.05 inches. In one preferred embodiment of the 
capsulectomy apparatus of the present invention, the cutting head 
resembles a four-sided pyramid with concaved walls having a radius of 
curvature of approximately 0.037 inches. Both the number of sides 
associated with the polyhedrical structure and the radius of curvature 
associated with each wall thereof can be varied to achieve the efficacies 
desired. Further, the angle of the head with respect to the rod is 
approximately 70 degrees. However, the angle of the head with respect to 
the rod can vary from approximately 60 degrees to approximately 120 
degrees. The disposable needle locks into the handpiece by attachment of 
the male to the female end as illustrated in the drawings.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT 
Reference will now be made in detail to the present preferred embodiment of 
the invention as described in the accompanying drawings. 
In FIG. 1 there is shown an illustration of a console 100 associated with 
the capsulectomy apparatus of the present invention. The console 100 is 
emcopassed by the housing 102. On the front of the housing 102 is the 
panel 104. The panel 104 has indicators for determining the accurate 
operation of the capsulectomy apparatus of the present invention. On panel 
104 are the cutting indicator 106, the irrigation indicator 108, the fault 
indicator 110, the test button 112, the ready indicator 114, the needle 
indicator 116, the handpiece indicator 118, the timer 120, the reset 122, 
the battery charge indicator 124, and the battery low indicator 126, Also, 
illustrated in FIG. 1 is the irrigation solenoid 128. 
FIG. 2 is an illustration of the handpiece 200 of the capsulectomy 
apparatus of the present invention. Also illustrated in FIG. 2 is the 
disposable needle 300. The disposable needle 300 is engaged with the end 
204 of the handpiece 200. The end 204 is affixed to the case 202. On the 
case 202 is a switch 206 for activating the needle 300. Also illustrated 
in FIG. 2 are the power cable 210 and the irrigation tube 208. 
FIG. 3 illustrates a presently preferred embodiment of an electrical 
circuit used in the console 100 of the present invention. As illustrated 
in the circuit of FIG. 3, the transducer 130 provides a resistance of 400 
ohms. 
The transducer of the present invention is illustrated in its presently 
preferred embodiment in FIG. 4. The transducer 130 is similar to a 
"loud-speaker-type" moving coil motor. More particularly, the preferred 
embodiment of the transducer 130 comprises a cup 216 in which a coil 214 
and a magnet 212 provide oscillation motion. The shaft 218 which is 
fixedly secured to the magnet 212 oscillates as does the magnet 212. The 
shaft 218 is kept in position within the handpiece 200 by the suspension 
members 220. Affixed to the end of the shaft 218 is the female actuator 
230. Thus, as the magnet 212 vibrates, the shaft 218 vibrates and the 
female actuator 230 vibrates. 
FIG. 5 illustrates the end portion of the handpiece 200 engaged with the 
needle 300 of the capsulectomy apparatus of the present invention. The 
primary components illustrated in FIG. 5 are the shaft 218 and the female 
actuator 230 of the handpiece 200 as well as the toggle 240, the end 250, 
the sleeve 310, the rod 320, and the fluid retainer diaphram 364 of the 
needle 300. 
FIG. 6 is a sectional view of the end 350 which engages the handpiece 200 
of the capsulectomy apparatus of the present invention. Of particular 
interest in FIG. 6 are the end channel 352, the irrigation channel 354, 
and the fluid chamber 356. The rod 320 of the needle 300 passes through 
the end channel 352 and the fluid chamber 356 into the rear portion of the 
end 350. The sleeve 310 is fixedly engaged with the end channel 352. 
FIG. 7 is a cross-sectional view taken along the section line 7--7 in FIG. 
6. FIG. 7 illustrates the front portion of the end 350. Also, FIG. 7 
illustrates the off-centered location of the first foot 358 relative to 
the second foot 360. 
FIG. 8 is a cross-sectional view taken along the section line 8--8 in FIG. 
6 illustrating the end 350. FIG. 8 provides a center, cross-sectional view 
of the end 350. The needle channel 352 and the irrigation channel 354 are 
readily illustrated in FIG. 8. Also illustrated in FIG. 8 is the slot 362. 
The slot 362 is longitudinally disposed within the end 350. The slot 362 
is disposed to form a rectangular channel through the central longitudinal 
axis of the end 350. 
FIG. 9 illustrates the presently preferred embodiment of the toggle 340 
which interacts with the end 350. The toggle 340 comprises the male end 
342 and, disposed on the opposite end of the toggle 340, the first 
securing member 344 and the second securing member 346. The securing 
members 344 and 346 movably engage the end 350 within the slots 362. 
FIG. 10 is a cross-sectional view of the toggle 340 taken along the section 
line 10--10 in FIG. 9 best illustrating the male end 342. Specifically, 
FIG. 10 illustrates the aperture 348 which accepts and secures the rod 
320. Thus, as the toggle 340 moves in the slots 362 of the end 350, the 
rod 320 moves within the sleeve 310. FIG. 11 is a cross-sectional view 
taken along section line 11--11 in FIG. 9 illustrating another perspective 
of the toggle 340. 
FIG. 12 illustrates a presently preferred embodiment of the female actuator 
230. The female actuator 230 comprises the driver end 232 and the securing 
members 234 which form a funnel. 
FIG. 13 is a cross-sectional view taken along the section line 13--13 in 
FIG. 12 illustrating the female actuator 230 rotated 90 degrees from the 
position illustrated in FIG. 12. Upon rotating the female actuator 90 
degrees, a securing channel 236 is formed. FIG. 14 is a cross-sectional 
view taken along section line 14--14 in FIG. 13. 
FIG. 15 illustrates the use of the needle 300 within the eye. The needle 
300 enters the eye at point C. As illustrated in FIG. 15, the head 330 of 
the needle 300 is actively cutting the lens B. The needle 300 is 
illustrated with the sleeve 310 and the rod 320 passing therethrough. 
Fixedly secured to and illustrated as a part of the rod 320 is the head 
330. The head 330 is the active cutting member of the needle 300. 
FIG. 16 is a blown-up illustration of a portion of the rod 320 and the head 
330. Of particular importance in the present invention, is the angle of 
declanation of the central axis relating to the head 330 and rod 320. This 
angle is illustrated as approximately 70 degrees. However, a range of 
angles of declanation from approximately 70 to 135 degrees provides 
enhanced cutting characteristics. The head 330 is illustrated as having 
four cutting edges 332. Preferably, the head 330 can be configured to have 
from 2-5 cutting edges 332 for the currently performed ophthalmic 
procedures. However, the head 330 could be readily adopted with more than 
five (5) cutting edges 332. 
FIG. 17 is a cross-sectional view taken along section line 17--17 of FIG. 
16 which better illustrates the four cutting edges 332. The cutting edges 
are anglelarly specific based upon the number of edges 332 associated with 
the head 330 used, i.e., 2-5 edges 332 may be used. 
FIG. 18 is a cross-sectional view taken along section line 18--18 in FIG. 
16 illustrating the curvature associated with each cutting surface 334. 
Preferably, the cutting surfaces 334 have a radius of curvature of less 
than 0.05 inches. For the apparatus illustrated in FIGS. 15-18, the radius 
of curvature is approximately 0.307 inches for the four sided polyhedral 
structure of the head 330. 
FIG. 19 illustrates the needle 300 utilized in the capsulectomy apparatus 
of the present invention. The toggle 340 is movably affixed in the slot 62 
of the end 350. The sleeve 310 is fixedly secured to the end 350. The rod 
320 is fixedly secured to the toggle 340 adjacent to the securing channel 
349. The rod 320 passes between the securing members 344 and 346 through 
the end 350, and through the sleeve 310 to extend out of the sleeve 310. 
The head 330 is affixed to the end of the rod 320 or is an extension 
thereof. As the toggle 340 is moved in the slot 362, the rod 320 moves 
within the end 350 and the sleeve 310 causing the head 330 to oscilate. 
FIG. 20 illustrates the needle 300 being affixed to the handpiece 200. The 
female actuator 230 is affixed to the shaft 210 which is driven by the 
transducer apparatus within the handpiece 200. The male end 342 of the 
toggle 340 is moved into the funnel created by the securing members 234 
and 236. The feet 358 and 360 on the end 350 slide into slots which 
prevent the male end 342 and female actuator 230 from being engaged 
improperly. After the male end 342 is completely engaged in the funnel of 
female actuator 230, the needle 300 can be rotate 90 degrees so that the 
first foot 258 and the second foot 260 lock into place to fixedly secure 
the needle 300 to the handpiece 200. The securing channel 236 of the 
female actuator 230 is wrapped around the male end 342 of the toggle 340. 
Similarly, the securing members 234 and 236 of the female actuator 230 
have engaged the securing channel 349 of the toggle 340. Thus, as the 
needle 300 is rotated 90 degrees, the feet 358 and 360 removably engage 
the handpiece 200 to fixedly secure the needle 300. However, as the female 
actuator 330 is driven by the shaft 218, the rod 320 is oscilated within 
the sleeve 230 to cause the head 330 to provide a cutting action. 
FIG. 21A illustrates a plan view of the preferred embodiment of the 
insertion tool 400 used with the capsulectomy apparatus of the present 
invention. The insertion tool 400 is illustrated having a closed end 402 
and remotely disposed therefrom an opened end 404. Associated with the 
opened end 404 are the extensions 406. The extensions 406 are linear 
extensions of the cylindrical sides of the insertion tool 400. 
FIG. 21B illustrates an elevation view of the preferred embodiment of the 
insertion tool 400 as illustrated in FIG. 21A. Remote from the closed end 
42 is the opened end 404 having associated therewith the extensions 406. 
The extensions 406 are illustrated with the lower extension lying directly 
under the upper extension and thus the lower extension 406 is out of view 
in FIG. 21B. 
FIG. 22 is a section view illustrating the arrangement of the insertion 
tool 400 to the needle 300 prior to engaging the needle 300 with the hand 
piece 200 (the latter not illustrated in FIG. 22). The insertion tool 400 
is illustrated engaged over the toggle 340 of the needle 300. The 
extensions 406 extending from the opened end 404 of the insertion tool 400 
abuttedly engage the foot 358 associated with the toggle 340 of the needle 
300. 
It has been found that adequate cutting frequencies are between 50 and 300 
Hz. Also, it has been found that the amplitude of motion of the rod 320 
within the sleeve 310 caused by the movement of the actuator 230 is 
between 0.005 inches and 0.050 inches. It can be readily derived by one 
skilled in the art that differing frequencies and amplitudes of the motion 
may readily enhance the use of the present apparatus for different 
surgical techniques of cutting needs. 
OPERATION 
In operating the capsulectomy apparatus of the present invention, the 
handpiece 200 is connected to the console 100 via the power cable 210. The 
irrigation tube 208 attaches to the console 100 at the irrigation solenoid 
128. Use of the irrigation tube 208 is optional and at the discretion of 
the operator. The console 100 requires power from readily available 
sources. Preferably, the console 100 is battery powered. The 
instrumentation associated with the capsulectomy apparatus of the present 
invention provides that the handpiece indicator 118 illuminates when the 
handpiece 200 is properly set and functional. The needle indicator 116 
illuminates to notify the operator that the handpiece 200 and the needle 
300 are properly set. The test button 112 runs for approximately three (3) 
seconds to determine if the capsulectomy apparatus is ready for operation. 
The internal circuit determines the presence of a spike on the wave form 
which indicates the unit is vibrating. The irrigation indicator 108 and 
the cutting indicator 106 provide visual or audible communications to the 
operator. The fault indicator 110 illuminates when the needle 300 or 
handpiece 200 are disengaged or the power fails or the needle 300 
disengages. 
When the console 100 is activated, power is supplied to the transducer 130 
such that the shaft 218 drives the female actuator 230, the toggle 340 and 
the rod 330 within the sleeve 310 of the needle 300. Simultaneously, 
irrigation fluid enters the end 350 through the irrigation channel 354 for 
irrigating deep in the anterior chamber through hydrostatic pressure. The 
irrigation fluid is prevented from transfering into the main portion of 
the handpiece 200 by the fluid retainer diapham 364 (See FIG. 5). As the 
transducer 130 drives the rod 320, the cutting edges 332 and the cutting 
surfaces 334 of the head 330 cleanly and smoothly severe the lens B of the 
eye. 
After the needle 300 has been used, it is readily removed and disgarded. 
Another needle is engaged with the handpiece 200. The needle can be 
readily engaged with the handpiece 200 using any device which readily 
displaces the toggle 340 to its most recessed position. The sleeve 310 is 
inserted into the channel 352 such that the rod 320 removably engages the 
toggle 340. Thus, as the toggle 340 is activated by the female actuator 
230 due to the vibrating shaft 218, the rod 320 longitudinally fluctuates 
for cutting the lens B of the eye. 
An example of the types of surgery performed by the capsulectomy apparatus 
of the present invention is as follows: 
A peretomeh performed at the superior 90 degree segment using a No. 11 
sterrsharp blade. After the incision has been accurately placed, the 
surgeon takes the handpiece 200 from the nurse and depresses the 
handswitch or a footswitch. The flow of irrigation solution egresses a 
bottle suspended on an IV pole. The surgeon enters the anterior chamber at 
the incision site by rotating the handpiece 200 ninety degrees such that 
the blade is horizontal or parallel with the incision. The anterior 
chamber deepens and the surgeon then rotates the handpiece 200 ninety 
degrees back to the original position. The surgeon punctures the anterior 
lens with the needle capsule at any point. The handswitch or footswitch is 
then depressed to a second position which activates the cutting mechanism. 
The surgeon then guides the handpiece in such a fashion as to "draw" the 
desired shape capsulectomy in one continuous motion. The shape can be 
circular, ellipticial, D-shaped or any other shape depending on surgeon 
preference. The end result from this sequence of events is the production 
of a tag-free, free-floating, continuous, smooth, curvilinear anterior 
capsule flap with no stress on the zonules. The anterior capsule remaining 
will facilitate placement of an intraocular lens (IOL) in the capsular 
bag. 
The head 330 must be in constant contact with the capsule to ensure a 
smooth cut. The needle 300 does not have to be perpenduclar to the plane 
of the capsule at all times as with prior known devices. 
To remove the handpiece 200 from the eye, the needle 300 is rotated ninety 
degrees and withdrawn through the incision. A capsulectomy performed with 
this method can be accomplished within approximately 5 to 10 seconds.