llnited States Patent [72] Inventor Joseph R. Valinoti, Jr.
80 Lake Road, Manhasset, N.Y. 11030 [21] Appl. No. 807,188 [22] Filed Mar. 14, 1969 [45] Patented Dec.7, 1971 [54] APPARATUS FOR ELECTROSURGICAL Primary Examiner-Channing L. Pace Attorney-Albert M. Parker ABSTRACT: A method and apparatus employing a highfrequency electric current having a bell as one electrode inserted within the foreskin and having a relatively fine stainless steel wire tightly encircling the foreskin at the position where the foreskin is to be cut. The wire serves as the other electrode and overlies an opposed area of the bell within the foreskin. A source of high-frequency current has its leads connected to the bell and wire, and current of cutting frequency, suitably timed for the cut to be made, is applied to effect the cut beneath the wire. The bell has electrical insulation applied to its exterior surface and preferably has heat-insulation material applied to its interior surface.
PATENTEU DEC 7 I971 INVENTOR. JOSEPH R VALINOTI ATTORNEY SHEET 3BF 2PATENTEU DEC 7 I97!SHEET 2BF 2 INVFNTOR JOSEPH R. VAUNOTIJI:
ATTORNEY 1 APPARATUS FOR ELECTROSURGICAL CIRCUMCISION THE PRIOR ART Heretofore circumcision has been effected by mechanical cutting perfonned in various manners. First it has been necessary to carry out yarious positioning and clamping steps not only to facilitate the cutting but also to assist in keeping down the incidence of bleeding and for prevention of infection. The cutting has been principally effected by the use of knife or scissors, though the use of other cutting and clamping edges have been proposed as has the idea of effecting the cut by tightening fine wii'es about the internally supported foreskin. In spite of the precautions taken and the instrumentalities employed, there remained the four possibilities of some bleeding, infection, separation of skin and mucosal layers, and contraction of scar tissue.
RESUME OF THE INVENTION The greatest contribution of the method and apparatus of the invention is providing for substantially bloodless circumcision or elimination of hemorrhage by a cutting method which seals the blood vessels as it cuts. This sealing of the blood vessels almost entirely eliminates infection, common in the prior art. By achieving the desired result with a few easy steps and by eliminating most of the postoperative treatment formerly needed for tissue separation and scar contraction the method and apparatus of the invention greatly simplify the performance of circumcision through elimination of steps heretofore though h'ecessary, by employing simple and readily operable equipment.
Whereas the pri'oi art mechanical cutting procedure commonly called for special clamping and holding prior to severing. the invention combines these steps all in one. Any clamping of the invention is merely the securing and tightening of the snarelike outer electrode. Once that is secured the severing of the foreskin is effected merely by turning on the high frequency current for the properly timed interval. The severing is effected by the high frequency current which, at the same time, seals the blood vessels so that the postoperative hazard of infectioii is practically eliminated. Furthermore there is none of the pi'ior art danger of cutting the frenulum or glans.
Besides simplification of procedure the invention employs apparatus of the utiiiofst simplicity. Having available a unit for converting the normal alternating line current into current of frequency needed for electrosurgery, it is merely necessary to position the specially formed properly protected bell under the foreskin, tighten the wire snare in the proper position and turn on the current for the required time. Such high frequency generators normally ave timers as well as frequency selectors so they merely need to be set properly.
It is accordingly an object of the invention to simplify the performance of the circumcision operation.
Another object of the invention is to effect severance of the prepuce or foreskin Without incurring bleeding.
Still another object is to simplify the equipment needed for performing the circumcision operation.
A further object is' t'o perform the circumcision operation with the minimum of discomfort to the patient.
Further objects are to seal blood vessels, substantially eliminate the dangers of infection, separation, and contraction, and reduce the time involved in performing circumcision.
Still further and more detailed objects will in part be obvious and in part be poii'ited out as the description of the invention taken in conjuiietion with the accompanying drawing proceeds.
In that drawing:
FIG. I is a side elevation view of the specially formed bell in accordance with the invention.
FIG. 2 is a central vertical section taken on a plane through F IG. 1 parallel to the plaiie of the paper.
FIG. 3 is a four-times enlargernent of a section taken on line 3-3 of FIG. 2 and lookirig in the direction of the arrows.
FIG. 4 is a vertical central longitudinal section of the snare and tightening device therefore in accordance with the invention.
FIG. 5 is an elevational view showing the bell seated within the prepuce in position for excising and showing the wire being brought into position for use.
FIG. 6 is a part sectional, part elevational view showing the bell of FIGS. 1 and 2 inserted within the prepuce of the patient ready for the application of the exterior wire snare.
FIG..7 is an elevational view of the complete apparatus assembled with the wire in position and tightened up ready to excise the prepuce of FIGS. 5 and 6.
In FIGS. 1 -33 the bell-shaped member employed to space the foreskin from the glans is shown per se and. along with its positioning stem, is generally indicated at l. The bell part is shown at 2 and the stem at 3. Thebell 2 extends from the joiningarea 4 with the stem in a domed portion 5 continuing in a generally cylindrical short sidewall portion 6. The domed portion 5 has asmall hole 7 therethrough to permit voiding.
The cylindrical formation of the sidewall 6 terminates at anannular groove 8 extending into the wall from the exterior surface and angled obliquely with respect to the axis of the cylinder. Thegroove 8 serves as the locating and positioning means for the wire used to surround the foreskin as will appear hereinafter. The oblique angle of thegroove 8 is selected to parallel but lie outwardly of the normally formed corona glandis so that the line of severance of the foreskin will follow such a path.
From thegroove 8 the bell flares conically outwardly in ashort portion 9 to terminate in anoblique end 10 generally parallel to thegroove 8 and formed to overlie the corona glandis in outwardly spaced relation with respect thereto. This positioning of the oblique areas of the bell with respect to the penis ofthe patient will ofcourse depend upon the selection of a bell of proper size.
The body of thebell 2 is of metal and good electrically conductive characteristics as is thestem 3 which is advantageously formed integrally with thebell 3. Thestem 3 is of such length as is desired for facilitating positioning of the bell on the patient without being heavy or cumbersome. The outer end 11 of the stem may be suitably formed for the reception of a sparkplug type of electrical connector as shown, or it may be otherwise contoured or just left plain for contact with some other form of connector of which a so-called alligator clip, is a nonlimiting example. All that is necessary is that good electrical connection be made between the connector and the end 1 l.
Thehell 2 has its wall coated both externally and internally as seen in the greatly enlarged sectional showing of FIG. 3. First the outer wall is given acoating 14 of a tough electrical insulating material. This is to assure that should the wire used as one electrode for setting up the high frequency field in some manner come into contact with thebell 2 it will still be isolated from the metal of the bell by the insulation. Thus short circuiting between the metal of thebell 2 forming one electrode and the surrounding wire forming the other electrode with obvious undesirable results is prevented.
Epoxy resin provides one example of a suitable insulation coating at 14. It adheres well, is a good insulator and is hard and tough. Other materials having similar characteristics may of course be employed instead of the epoxy.
Thebell 2 is also coated interiorly as seen at 15 with suitable material to form a nonheat-conductive layer orheat shield 15. Highly effective materials for this purpose have resulted from space technology while sufficiently effective ones existed in other fields of endeavor.
The severing here is by means of a high frequency cutting current effected in a short period of time. It is by no means a cauterizing or coagulation current. Instead the heat generated at the cut is negligible. However the bell tends to heat somewhat under the action of the high frequency current so the layer I5 is desirable to protect the underlying tissues from overheating. The wire used for the exterior electrode is shown at 16 in FIG. 4. Aholder 17 for the wire includes adjusting and tightening means 18 and anelectrical contact member 19. Thisholder 17 is just one form of device useable for this purpose. Various others would readily suggest themselves to those skilled in the art, without departing from the spirit or scope of the invention.
The important thing is to have the wire tightened against the exterior of the foreskin throughout the whole of its periphery and tightened uniformly so that contact and cutting will take place throughout. This can be accomplished quite effectively merely by twisting the ends of the wire together to both tighten it in place and secure its ends. Then an electric contact member can be engaged with the twisted portion.
Thewire 16 is of stainless steel and is relatively fine, preferably having a diameter of approximately 0.0l inch. In the FIG. 4 showing the wire is in the form of a snare whose ends 20 and 21 extend through the central bore of aprojection 22 extending from thesolid end 23 of theholder 17.
Theelectrical contact member 19 is also seated in theend 23 and terminates inwardly in a returned U-form ofclamp member 24 which receives the returnedend portion 25 of thewire end 20. Thus when thescrew 26 of the connector is tightened theportion 25 is tightly engaged and clamped tightly against thewire end portion 21.
Thechamber 27 in theholder 17 houses aspring 28. One end of thespring 28 is secured to the inner extremity of thewire end 21 while theother end 30 is secured to arod 31 extending from the end of an adjustingscrew 32 threadedly received in the remote end 33 of theholder 17. An adjustingwing 34 carried by thestem 18 outside of theholder 17 facilitates actuation of thescrew 32 to either pull on or release thespring 28. In this way theend 21 of thewire 16 can be pulled or released depending upon the size of loop of thewire 16 needed and the tension to be applied to the selected size loop to make tight and uniform contact with the foreskin.
To complete the description of the apparatus reference is made to FIG. 7 wherein the assembled system ready for actuation is illustrated. Here a high frequencycurrent generator 37 is shown as receiving its power by means of acord 38. The generator is equipped with asettable timer 39 and one of itsoutlet connectors 40 has an off switch in its line. Theconnector 40 extends to and makes contact with theconnector 19 and through the same to thewire 16. Theother connector 42 makes connection back to thegenerator 37 by asuitable ground 43 and makes contact with the end of thestem 3 by means ofa sparkplug-type connector 44.
Considering now the method of the invention the bell 1 must first be seated in place within theprepuce 47 with its terminating end seated near thecorona glandis 48, (FIG. 6). Theend 10 is inclined with respect to a transverse plane extending at right angles to the axis of thebell body 2 in order to mate with the corona glandis which is similarly inclined. The glans 49 (FIG. 6) lies within the bell and is protected from heat by the short time needed for the cutting and by the heat insulation on the interior of the bell.
In seating the bell within theprepuce 47 it is often necessary to slit the prepuce longitudinally by means such as surgical scissors, otherwise theend portion 50 ofthe prepuce would be too small to allow insertion of the bell. This does result in bleeding but the bleeding tissue is removed with the subsequent removal ofthe prepuce, creating no difficulty.
Once the hell 1 is properly seated within the prepuce thewire 16 is brought into position on the outside. This act of positioning is illustrated in FIG. 5 while the final seating with the wire drawn up tight is shown in FIGS. 6 and 7. From these showings it is seen that thenarrow band 51 of prepuce where the severing is to take place is drawn into thegroove 8 of the bell by the tightening of thewire 16. This not only acts to locate and clamp the bell and prepuce in proper relationship but it localizes the zone of action of the high frequency current, assuring a fine clean cut.
The tightening of thewire 16 after it is properly positioned is effected by turning thewing 34 ifa holder such as 17 is used. Then thespring 28 will maintain the wire in tight uniform engagement with theband 51 of prepuce. Other wire holding and tightening means may of course be used or, as mentioned above, a wire can be readily tightened in position by twisting the ends of it together with a pair of pliers. Then electrical connection with the twisted ends can be effected by the use of an alligator clip or the like.
In the instant showing electrical connection with the bell 1 through itsstem 3 is illustrated as being effected by the use of asnap connector 44 engaging the recessed portion 11 of thestem 3 in manner of applying an ignition wire to a spark plug. This is done after thewire 16 is tightened in place in alignment with thegroove 8. Other suitable connectors may of course be employed in place of that shown at 44.
Referring now to FIG. 7 wherein the system is illustrated being all hooked up ready for the operation thetimer 39 is set to the time known to the operator to be needed for the operation to be performed. For the circumcision of infants a more or less standard time is determined and adhered to. With a high frequency field as used in electrosurgery, of which a frequency of l0,000 cycles per second is a nonlimiting example, the time needed to sever the prepuce can well be kept within the range of2 to 5 seconds.
Since thetimer 39 controls the time of current flow to create the high frequency action the operator merely needs to move theswitch 41 to the on position and leave it there. The timer shuts off the current when the time for which it is set has elapsed.
With all steps as above referred to properly taken the prepuce, from thewire 16 distally, will be neatly severed from the remainder. No bleeding will take place at the remaining end and there is no chance of injury to the glans 49 nor to the frenulum for they are protected by the bell and the severing is limited to the section between thewire 16 and thegroove 8. Furthermore discomfort from any heating of the glans is eliminated for, in the first place, this is not a hot wire or cautery type of operation, and, secondly. any heat that does develop is shielded against by the heat insulation layer on the inner surface of the bell. Short circuiting between the bell and wire is prevented by the electrical insulation coating on the outer surface of the bell, as well, ofcourse, in thegroove 8.
From the foregoing it will be apparent that the invention enables circumcision to be effected simply. quickly. with a minimum of steps, with a minimum of discomfort to the patient, all while practically eliminating any danger of infection. The foregoing are intended to be illustrative of method and apparatus for carrying out the invention, it being appreciated that those skilled in the art may well device variations thereof or improvements therein without departing from the spirit and scope of the invention.
Having described my invention what I claim as new and desire to secure by Letters Patent is:
1. Electrosurgical circumcision apparatus comprising a hollow bell-like member fonned of current-conducting material with an electrical connecting member thereon for grounding said bell, said bell member being formed with a locating and current localizing annular recess in the outer wall thereof adjacent the open end of said bell and an electrical insulation coating carried by the wall of said recess and extending throughout said wall.
2. Apparatus as in claim 1 and including a thermal insulation coating on the interior surface of said bell and extending substantially throughout the same.
3. Apparatus as in claim 1 said electrical insulation coating extending substantially throughout said outer wall.
4. Apparatus as in claim I, said bell flaring outwardly from said recess to said open end.
5. Apparatus as in claim 1 and including fine wire means adapted to overlie said groove and means to form said wire means into a loop and to tighten said loop to draw the same toward said recess.
6. In a system for use in electrosurgical circumcision, a bell formed of current-conducting material for insertion within the prepuce and to overlie the glans, an electrical contact engag- 8. A system as inclaim 7, said bell having its exterior surface coated throughout with an electrical-insulating coating and having its interior surface coated throughout with a heatinsulating coating.
9. A system as inclaim 7, said high frequency generator including a timer for controlling the time of operation thereof.
i i it i t UlIZTED ST 'iES PNFEIT OFFICE I'D-40th) (5/65) Dated December 7, 1971 Joseph R. Valinoti Patent No.
Inventor(s) appears in the aboire-identified patent It is certified that error hat said Letters Patent are hereby corrected as shown below:
and t "end", the reference numeral Col. 3,line 25, after -29- should be added Col. 4,line 48, "device" should read --devise-.
Signed and sealed this 8th day of August 1972 (SEAL) Attest:
EDWARD M.F'LETCHER,JR. ROBERT GOTTSCHALK Attes ting Officer Commissioner of Patents