|Publication number||US3884238 A|
|Publication date||May 20, 1975|
|Filing date||Apr 3, 1974|
|Priority date||Jun 19, 1972|
|Publication number||US 3884238 A, US 3884238A, US-A-3884238, US3884238 A, US3884238A|
|Inventors||Conor C O'malley, Sr Ralph M Heintz|
|Original Assignee||Malley Conor C O, Sr Ralph M Heintz|
|Export Citation||BiBTeX, EndNote, RefMan|
|Patent Citations (3), Referenced by (149), Classifications (12)|
|External Links: USPTO, USPTO Assignment, Espacenet|
United States Patent OMalley et al.
[ May 20, 1975 1 APPARATUS FOR INTRAOCULAR SURGERY Primary Examiner-Channing L. Pace  lnventors: Conor C. OMalley, 1323 Gleneyrie figg 'f Agent or plumb-Ben Chromy; Gerald Dr., San Jose, Calif, 95125; Ralph M. Heintz, Sr., 14734 Blossom Hill Rd., Los Gatos, Calif. 95030  ABSTRACT  FIIed: Apr. 3, 1974 A neumaticall 0 erated intraocular sur er a ara- 21 A 1.N 457,497 P Y P g y PP 1 pp 0 tus which is of very light weight and small size, the
Related US. Application Data cutting device inserted into the eye consisting of con-  Continuation-impart of Ser No. 264,166, June 19, centric tubes having a diameter of l or less 1972, Pat. No. 3,815,604. Pneumatic means is provided to the device for moving one of the tubes with respect to the other at a slow or  US. Cl 128/305; 128/276 fast rate. Said pneumatic means includes a bellows  Int. Cl A6lb 17/32 provided with suction so that vitreous sucked into one  Field of Search 128/305, 276 of the tubes is sheared off by the sharp end of the other tube and the severed vitreous is sucked into a  References Cited calibrated cylinder. An adjustable bleeder valve is pro- UNITED STATES PATENTS vided in the vacuum line to eliminate residual suction 3 614 10/1971 MOSS 128,305 on the interior of the eye when the cutting action is at 3,776,238 12/1973 Peyman et al..... rest- 3,815,604 6/1974 OMalley et al. 128/305 8 Cl 11 D F arms ra n I res FOREIGN PATENTS OR APPLICATIONS m g 437,932 11/1926 Germany 128/305 K T: F s70 67 PATENTEDHAYZOIQYS SHEET 2 BF 5 FIG.3
SI 50 Sla FIG.4
PATENIEDHAYZOIHYS SHEET t [If 5 w m J Wm uwm 7 mgmggmzoms 3884.238
SHEET 5 or 5 FIGJQ APPARATUS FOR INTRAOCULAR SURGERY DESCRIPTION OF THE INVENTION This application is a continuation-in-part of application Ser. No. 264,166 filed June 19,1972 now US. No. 3,815,604 dated June 11, 1974.
This invention relates to apparatus for use in effecting intricate surgery such as performed by an ophthalmic surgeon.
In certain diseases of the eye or in certain trauma it is necessary to sever the vitreous which is a relatively complex substance composed of a framework of long protein molecules (collagen). In addition the vitreous also includes patches or balls of a second protein molecule (hyaluronic acid) which help to strengthen the vitreous and maintain its form and assist in holding water which comprises over 99 percent of the vitreous. When the surgeon finds it necessary to remove the severed vitreous or extraneous matter from within the vitreous, this removal must be accomplished without damage to the retina, to the choroid which underlies the retina or to the optic nerve or to the blood vessels associated therewith. This, of course, is no easy task as the vitreous cannot be cut by a scalpel or other similar instrument since the vitreous is relatively tough and simply folds over the edge of the knife and refuses to be severed. Various devices have been proposed for vitreous surgery and reference is made to such devices in the following published articles.
G. C. Couvillion, H. M. Freeman, and C. L. Schepens on pages 722 and 723 of Volume 83, June 1970, Arch Ophthal, describe vitreous surgery using scissors. Robert Machemer, Jean-Marie Parel and E. W. D. Norton on pages 462 to 466 of Volume 76, March-April 1972, Tr. Am. Acad. Ophth. and Otol., describe a vitreousinfusion-suction-cutter for vitrectomy. The cutter described in this article is provided with a rotating inner tube that is pushed by a spring against an end of an outer tube. A cutting hole which is slightly laterally displaced, is provided in the end of the tip. In another article entitled Experimental Vitrectomy, in Volume 86, November, 1971, Arch Ophthal, G. A. Peyman and M. A. Dodich describe an instrument for cutting vitreous strands by a chopping action produced by an inner tube against the plane end of an outer tube. The vitreous to be removed is drawn into the inner tube by suction provided in the inner tube. In this device another tube is attached alongside the outer tube and saline solution is supplied through this tube to replace the removed vitreous. In this device the chopping action is produced by oscillating the inner tube to 50 times per second and this is achieved by electrically energizing a small solenoid that is attached to the inner tube. The June, 1970 issue of Arch Ophthal contains an article by W. D. Cockerham, C. L. Schepens and H. MacKenzie Freeman entitled Silicone Injection in Retinal Detachment. The authors describe a procedure in which a cc syringe which is attached to a blunted No. 18 or No. 20 needle is inserted into the eye through a meridional sclerotomy placed in the middle of the pars plana ciliaris for silicon injection.
It is therefore an object of our invention to provide an improved device for cutting vitreous, severing adhesions, said device having an adjustable and vacuum control means for removing severed parts from the eye.
Another object of this invention is to provide an improved device for use by eye surgeons, said device having an intraocular surgery device operated by pressure and vacuum to which fail-safe vacuum control is provided to abolish any significant residual suction on the interior of the eye when the cutting action is at rest.
Still another object of our invention is to provide improved tools for use by eye surgeons, said tools being so small that they may be inserted into the eye through the pars plana.
A further object of our invention is to provide improved tools for use by eye surgeons, the portion of the tool to be inserted into the eye having a diameter of about 1 mm., or less and the whole instrument being small and lightweight so that it can be hand-held and manipulated with ease and with minimal damage to the eye.
Another object of this invention is to provide an improved device for use by an ophthalmic surgeon for performing surgery in the eye of a patient, said device comprising a cutting device employing extremely small concentric tubes and pneumatic means including a bellows attached to one of said tubes for reciprocating said tube with respect to the other and an adjustable bleeder valve that is controlled by the surgeon to enable him to control the vacuum or suction applied to said cutting device for removing the severed substance from the eye.
Other and further objects of our invention will be apparent to those skilled in the art to which it relates or will be pointed out in detail in the following specification, claims and drawing.
By this invention we have provided the eye surgeon with an operating tool that :is characterized by its extremely small size and light weight for performing surgery within the eye of the patient. This instrument may of course be used for cutting material other than vitreous by the operating surgeon. Two types of cutting devices may be used although only one type is illustrated. One of these devices is referred to as the push-cut and the other is referred to as the pull-cut. Both of these types of devices have the same dimensions and weight (about 8 grams) and in each case the length is about 2 inches overall with the body or handle thereof having a length of 1 inch and the cutting tube also having a length of 1 inch. The diameter of the cutting tube is 0.035 inch (0.9 mm.). The body or handle comprises a cylinder with a bellows in it: and the cutting tube is rigidly fastened to the bellows. This cutting tube is positioned inside of an outer tube and is free to slide about 0.020 to 0.040 inch (0.5l.mm.) between limits set by a manually adjustable member on the handle. Vitreous to be severed is drawn into the port of the outer tube by suction and this vitreous is cut off when the sharp end of the inner tube is moved across the port of the outer tube. The frequency of the traverse of the cutting end of the inner tube across the port of the outer tube is controlled by an electrical circuit which generates timed electrical pulses for controlling air pressure and suction pulses to the piston of the cutting device. This frequency may be controlled by a foot actuated device which is operated by the surgeon employing this instrument. Thus, this frequency may be varied from a stationary condition with the port either open or closed to as many as traverses per second or more. The speed of excursion is dictated by the nature of the material being cut, its proximity to the retina, the optic nerve, blood vessels or other sensitive regions. Air pressure and vacuum are applied to the bellows of the cutting device through a flexible tube. A debris tube is positioned inside of the tube supplying pressure and vacuum. The annular space between the pressure tube and the debris tube serves to supply the bellow actuating the tube with air pressure and vacuum pulses and the debris tube is supplied with vacuum to suck the debris out of the eye and into a measuring cylinder.
The therapeutic role of the vacuum is threefold:
1. To suck selected target tissue into the cutting mechanism as described above;
2. To hold the target tissue throughout the cutting action which tends to spew it out of the cutting tube back into the eye; and
3. To move the cut specimen (or liquid when applicable) out of the eye through the debris tube.
The target tissues vary widely in mobility and texture. They are usually attached to other tissue (i.e., retina) which vary widely in friability anad mobility. While it is the surgical goal to cut and remove the target tissue, their contiguous attachments frequently must not be cut. Consequently, we have found it important to provide the following two vacuum controls to this apparatus:
a. Fail-safe vacuum control It is essential that there be no active or significant residual suction on the interior of the eye when the cutting action is at rest and it is desirable that this be controlled automatically to preclude the hazards of forgetfulness, etc. This control comprises a means for turning the vacuum off, a sliding valve to isolate the residual suction within the control unit, and a means for abolishing the residual vacuum between the sliding valve and the cutting port. Residual vacuum at the cutting port must be abolished as otherwise a small motion of the surgeons hand could be transmitted with dire consequences to the retina which is exceedingly easy to tear.
b. Quantitative vacuum control As the target tissues vary widely in mobility, texture and accessibility a level of suction which might be suitable for one situation might provoke disaster in another eye or in the same eye at a different point in time or space. Consequently, it is highly desirable technically and therapeutically that a range of vacuum be selectively and readily available to the surgeon to serve these everchanging needs as they are identified.
These objectives are met by an additional manual control which varies the vacuum delivered at the cutting opening.
Further details and features of this invention will be set forth in the following specification, claims and drawings in which, briefly:
FIG. 1 is a schematic diagram showing the various controls provided to this apparatus;
FIG. 2 is a side view of the pneumatic control device provided to this invention;
FIG. 3 is a sectional view of the control device taken along the line 33 of FIG. 2;
FIG. 4 is a sectional view of the control device taken along the line 4-4 of FIG. 3;
FIGS. 5 and 6 show an enlarged view of the vitreous cutting device, the left hand end of FIG. 5 being broken off of the right hand end of FIG. 6;
FIG. 7 is a sectional view taken along the line 7-7 of FIG. 5;
FIG. 8 is a sectional view taken along the line 8-8 of FIG. 6;
FIG. 9 is a front view of a device attached to the eye to inject saline solution into the eye as material is taken out of the eye;
FIG. 10 is a sectional view of the device shown in FIG. 9; and
FIG. 11 is a perspective view of the device shown in FIGS. 9 and 10.
Referring to the drawing in detail, reference numeral 1 1 designates a motor which is mechanically connected to the vacuum pump 12 and air pressure pump 13. Pumps 12 and 13 are connected by suitable tubes to the tanks 14 and 15, respectively. A vacuum gauge 16 is connected by suitable tube to the tank 14 and a pressure gauge 17 is connected by a suitable tube to the pressure tank 15. The motor 11 is connected to a suitable source of electric power such as is available in the conventional wall outlet and a switch (not shown) is provided for turning the motor on and off. An auxiliary switch 19 is provided between the power line and the DC. power supply 20 which converts the alternating current supplied thereto to direct current for energizing the multivibrator 21 and flip-flops 22 and 23.
Multivibrator 21 is provided for triggering the flipflop 22 which produces an output designated as mode A signal which may be supplied to the gate 24 through switch 25 when it is desired to actuate the solenoid 26 driving the valve 27 in this mode. In mode A the valve 27 is actuated to connect the output line 28 for equal intervals to the vacuum line 29 and to the pressure line 30 alternately. When the switch 25 is shifted to connect the output of flip-flop 22 to flip-flop 23 then the apparatus is operated in mode B and the wave form of this mode is supplied to the gate 24 and to solenoid 26 for controlling the valve 27 in accordance with this mode. In mode B the valve 27 is operated so that it connects the output line 28 to the vacuum or suction line 29 for an interval approximately three times as long as the interval during which this line 28 is connected to the pressure line 30. On the other hand the mode B signal may be used to connect output line 28 to the pressure line 30 for a longer interval than the interval during which it is connected to the vacuum line, if desired.
The desired mode may be selected by operating the switch 31 that is connected to the control box 32. A suitable foot control may be provided for actuating the switch 31, if desired. A variable resistor 33 which may also be varied by a conventional foot control, is connected to the multivibrator 21 for controlling the frequency of the pulses in modes A and B. Multivibrator 21 supplies electrical pulses for triggering flip-flop 22 and thus controls the frequency of the pulses produced by this flip-flop.
The tube 28 is connected between the valve 27 and the vacuum control device 34. The vacuum control device 34 which is shown in detail in FIGS. 2, 3 and 4, is provided with a T-connection 35 having two arms 35a and 35b and line 28b is connected to arm 35a. Arm 35b is connected to line 36 which may be connected either to the inlet 37 or inlet 38 of the control device 34 for purposes which will be described more fully hereinafter. The control device 34 is provided with a piston 39 of plastic that is slidable in the cylinder 40 and the ports 37 and 38 lead into this cylinder, one port 37 leading in below the piston 39 and the other port 38 leading in at the top end thereof, and the purpose of this will also be described hereinafter.
A piston rod 41 which is also plastic is attached to the piston 39 and extends into a small cavity 42 into which the small tube 43 also extends. This end of the tube 43 is carefully lapped and polished and provides a seat for the end of rod 41. Thus the lapped and polished end of tube 43 is alternately opened and closed by the end of the piston rod 41 as the piston 39 is moved back and forth during the operation of this device. The Luer type fitting 44 is attached to the control device 34 and provides a connection between the small cavity 42 and the cylinder 45 which may be of 5 cc. capacity calibrated in 1/10 cc. increments to measure the vitreous or other material removed from the eye of the patient. The standpipe 45a in cylinder 45 is connected by the line 46 to the top of the waste overflow bottle 47. The bottle 47 is also connected to the vacuum line 48 so that vacuum is provided therein.
The vacuum control unit 34 is also equipped with a bleeder valve 49 which is manually adjustable by means of the small knob 49a. Turning the knob 49a opens or closes the opening 49b by retracting the pointed valve member 49c from the opening or advancing this member into the opening. The valve cavity 49d cuts across the small tube 43 so that an adjustable amount of the vacuum or suction supplied to this tube from tube 44 leaks therefrom through the bleeder valve 49. Thus, bleeder valve 49 abolishes residual suction from the debris tube 50 that is connected to the small tube 43.
Tube 50 is positioned inside of the tube 51 which is attached to the projection 51a of the unit 34. The tubes 50 and 51 are attached to a cutting and debris extracting device such as indicated at 52 which may be either of the pull cut off type or of the push cut off type as disclosed in our application Ser. No. 264,166 or it may be of the type illustrated in FIGS. 5-8 of the drawing.
The cutting device 53 shown in FIGS. 5 to 8 inclusive, is provided with a housing 53 which also serves as a handle. A bellows 54 which is made of metal, is positioned inside of the handle and the end 54a of the bellows is cupped and soldered to the member 55 which forms part of a piston structure. The other end 54b is likewise cupped and soldered to member 57 which is threaded into one end of the housing 53. The inner end 56a of the tube 56 forms one stop for the piston 55 and wall 57a of of plug 57b in the other end of the housing forms a stop for the out strokes. The other end 56b of tube 56 extends out of the housing and the plastic hose or tube 51 is attached thereto. The position of the end 560 of tube 56 may be adjusted by rotating finger grip 58 so that the length of the stroke of the piston structure is adjustable.
The finger grip 58 is attached to member 59 which is threaded and soldered to sleeve 60 and sleeve 60 is soldered to tube 56. Thus, tube 56 may be rotated by the finger grip 58. Also sleeve 60 is threaded to member 57 which is threaded into the housing 53.Member 57 is provided with a scalloped flange 61 having evenly spaced scallops around its circumference as shown in FIG. 7. The scallops are engaged by the resilient fingers 58a of the finger grip 58. The distance between the scallops represents a predetermined angle of rotation of the finger grip 58 and tube 56. Thus, the length of the piston stroke as limited by the stop 56a may be set by the surgeon using this device. The surgeon determines the desired increase or decrease of the length of this stroke simply by keeping track of the number of scallops the fingers 58a traverse as he adjusts the finger grip 58.
A bearing member 62 is positioned in a slightly recessed part in the end 56b of the tube 56. This bearing member is supported in the tube 56 by radially extending vanes 62a shown in FIGS. 5 and 7 and the central part of the bearing member slidably receives the small tube 63, a portion of which extends outward beyond the bearing 62 and the plastic tube 50 is attached to this external portion. The small tube 63 extends into the tubular member 56 and the inner end thereof is attached to the member 64. Member 64 is provided with a hole for receiving the end portion of the small tube 63 which is soldered thereto. Member 64 is provided with a portion of reduced diameter which is threaded and the piston 55 is attached to this threaded portion. A nut 65 is also attached to this threaded portion to prevent the bellows end plate 55 from becoming loose. The plug 57b is threaded into the end of the housing 53 and the outer member 66 of the telescoping tubular members is soldered into a pole provided in the plug. The inner telescoping tubular member 67 extends from the outer tubular member 66 and plug 57b into a hole in member 64. Thus, the hole in the tubular member 67 communicates with the hole in the tubular member 63. The outer telescoping tubular member 66 is provided with a sharpened aperture or port near the outer end thereof so that vitreous or other substance to be severed may be drawn therein and severed by the sharp edge 67a of the inner tube 67. The outer end of tubular member 66 is heliarc welded closed and round and polished. All of the parts of the cutting device 53 are made of metal such as stainless steel so that the device may be disassembled and sterilized at a suitable temperature in an autoclave.
In the operation of this device the electronic apparatus as shown in FIG. 1 periodically energizes the solenoid 26 which is mechanically coupled to the valve 27 so that the vacuum line 29 is connected to the line 28 alternately with the air pressure line 30. Line 28 is connected to line 28b which is connected to the fitting 35 of the control device 34. Thus, vacuum and pressure are alternately supplied to the hose 51 through the fitting 35 of the control device 34. Thus vacuum and pressure are alternately supplied into the tube 56 of the cutting device through the space between the vanes 62a of the plug 62. Tubular member 56 is provided with a plurality of holes 56c through which vacuum and pressure are alternately supplied into the inside of the bellows 54. The ends 54a and 54b of bellows 54 are cupped and soldered to the piston 55 and member 57, respectively, to provide a good and lasting seal so that vacuum and pressure alternately move the piston 55 against the stop 56a and stop 57a. As the piston 55 is reciprocated between the stops 56a and 57a it moves the inner cutting tube 67 back and forth inside of the outer telescoping tube 66 so that the sharpened end 67a of the tube 67 is swept back and forth across the sharpened port 66a of the outer tube 66. At the same time as the tube 67 retracted and the port 66a is opened, vacuum or suction is applied through the port. This vacuum or suction is controlled by the control device 34 in which the piston 39 moves the piston rod 41 so that the end of the small tube 43 is alternately opened and closed. Vacuum or suction applied to the cavity 42 through the connection 44 is supplied into the tube 43 and hose 50 when piston rod 41 is retracted from the end of tube 43. The hose 50 is connected to the small tube 63 in the cutting device and this small tube extends into the member 64 so that the hole therethrough communicates with the hole through the inner telescoping tube 67 and suction is thus supplied to port 66a.
The control device 34 is provided with a bleeder valve 49 which is connected to the small tube 43 and bleeds off some of the vacuum or suction provided to this small tube. This bleeder valve abolishes residual vacuum or suction from the small tube 43, hose 50, tube 56, inner cutting tube 67 and port 66a.
The plug 57b provided to the cutting device 52 is provided with several small holes 570 which vent the cavity 57d to the outer atmosphere. The threaded nut 65 is positioned in the cavity 57d and moves in this cavity when the piston 55 is reciprocated during the operation of this device. Thus, during the outstroke of the member 65 in the cavity 57d air is fed into the cavity and then exhausted from the cavity during the instroke.
In FIGS. 9, 10 and 11 there is illustrated a device for attaching a small tube 70 to the eye of the patient. The tube 70 is provided with a sharp end 70a that is inserted into the eye and the other end 70b is attached by a small hose to a container (not shown) of saline or other solution to be supplied to the inside of the eye to replace material removed from the eye by the device previously described herein. The tube 70 may be of stainless steel or the like material and it is attached to the arcuate plate 71 that is curved to the outer contour of the eye. Plate 71 is held on the outside of the eye by threads 72 that are inserted a short distance into the eye as shown in FIGS. 9 and 10.
While we have shown and described a preferred embodiment of the invention, it will be understood that the invention is capable of variation and modification from the form shown so that its scope should be limited only by the scope of the claims appended hereto.
What we claim is:
1. Apparatus for intraocular surgery such as cutting or severing and removal of vitreous or other material from the eyeball of a patient comprising the combination of a pair of telescoping tubular members, a hollow handle, said tubular members including an inner end fixed to the handle and an outer end projecting from one end of the hollow handle, said tubular members each having vitreous shearing means comprising a sharp edge and a port at the outer end thereof with the ports being positioned to coincide when the tubular members are in the telescoped position, a bellows positioned in said handle, an end plate connected to one of the tubular members, means connecting said bellows to the end plate, sources of compressed air and vacuum, means connected to said sources for alternately supplying compressed air and vacuum to said bellows, means connecting said source of vacuum to one of said tubular members for drawing the material to be severed into said port, said bellows and said end plate being reciprocated by said compressed air and vacuum so that said material is drawn into said port to be severed by the sharp edge of one tubular member being moved across the port of the other tubular member, said connecting means intermittently connecting said source of vacuum to the inner one of said telescoping tubular members for drawing the severed vitreous out of said inner tubular member, and means abolishing residual vacuum from said port after the severing of said material is interrupted.
2. In apparatus for intraocular surgery for cutting or severing and removal of vitreous or other material from the eyeball of a patient, the combination comprising a first tube of very small diameter having a port near one end thereof, a second tube concentric with said first tube, said tubes fitting snugly together and one of said tubes being slidable with respect to the other, the end of said second tube adjacent the port of the first tube being honed and polished to provide a sharp cutting edge, a source of vacuum, means for connecting said source of vacuum to the inner one of said tubes for drawing vitreous into the first tube through said port, means reciprocating one of said tubes with respect to the other so that sharp end of the second tube crosses said port of the first tube and shears off said vitreous sucked into said port, a bleeder valve attached to said vacuum connecting means, said bleeder valve abolishing residual vacuum from said tubes and preventing vitreous from being drawn into said port when said reciprocating means is interrupted.
3. Apparatus as set forth in claim 1, further characterized in that the inner one of said telescoping tubular members is attached to said end plate, said handle having sto'p means limiting the reciprocating motion of said end plate. j
4. Apparatus as set forth in claim 3, further comprising means-for adjusting said stop means so that the stroke of said end plate is adjustable.
5. Apparatus as set forthin claim 4, further characterized in that said adjusting means comprises a rotatable member supported by said handle, and a member in said handle supporting said adjustable stop means,
said rotatable member being attached to said last memtioned member.
6. Apparatus as set forth in claim 1, further comprising an elongated member having an inner end in said handle, the inner end of said elongated member forming a stop for the out stroke of said end plate, said elongated member being hollow and the other end thereof extending out of said handle, said sources of compressed air and vacuum being connected to said other end to supply compressed air and vacuum into said bellows.
7. Apparatus as set forth in claim 6, further comprising a rotatable member on said handle for adjusting said elongated member to adjust the out stroke of said end plate.
8. Apparatus as set forth in claim 7, further comprising spring means attached to said rotatable member, a scalloped member attached to said handle, parts of said spring means engaging said scalloped member to control the rotation of said rotatable member in predetermined steps permitting the control to be positioned in the dark by feel.
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|U.S. Classification||606/107, 606/171|
|International Classification||A61F9/007, A61B17/00, A61M1/00|
|Cooperative Classification||A61M1/0037, A61F9/0079, A61F9/00763, A61M2210/0612, A61B2017/00544|
|European Classification||A61F9/007R6, A61M1/00H4|