Mou v. City of San Jose et al

Filing 1347

Mou v. City of San Jose et al

Doc. 1347 Att. 4

Case5:07-cv-05740-JF Document25-5

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United States Patent
Fischer

US005554159A
[I91 1111 [45]

Patent Number: Date of Patent:
t 711992 Huang e al.

* Sep. 10,1996
.

5,554,159

1541 INSTRUMENT FOR ELECTRO-SURGICAL EXCISOR FOR THE TRANSFORMATION

5.133.713

ZONE OFTHE UTERINE CERVM AND METHOD OF USING SAME
West Hartford, Conn. 06117

OTHER PUBLICATIONS
Cabot Medical "Cryomedics Disposable Lletz Electrodes" Catalog ZSI-UA. 3/94.B0. EUman International Catalog Bll-M-1099 pp. 7,8,19 and Back Cover.
Primary Examiner-Angela D. Sykes Assisrani ExminerStephen D Huane .

[76] Inventor: Nathan R. Fischer, 17 Lovelace Dr..
[ * ] Notice:

The term of this patent shall not extend beyond the expiration date of Pat. No. 5,403,310.
..

[571

.

ABSTRACT

[21] Appl. No.: 361,747

[22] Filed:

Dec. 22,1994
Related US Application Data ..

[631 Continuation-in-panof Ser. No. 192,132, Feb. 4.1994, Pat.
No. 5,403,310.

1511 h .Cl? ................................................. t [52] U S C1. ................................................ .. [58] Field of Search ...............................

A61B 17/39 606/45; 606/49

606/32, 33, 37, 606/39-41,45-47,49,119.170; 128/122, 639,642,649 References Cited

[561
1,741,740 2,447,169 4,485,812 4,834,095 4,846,175 4.887593 4,924.882

U.S. PATENT DOCUMENTS
1211929 811948 W1984 5/1989 711989 12/1989 511990
Sederholm et al. De Sousa . H m d a et al. .

.

Miller. Frimberger . Wiley et al. . Donovan.

includes an elongaled body member with an endocervical portion at one end, a contact poriion at the other end, and a r vaginal portion therebetween. A stop a m extends ai a right angle to the body member at thejuncture of the endocervical and vaginal portions, and a wire eleclrode extends diagonally between the stop arm and endocervical portion. Preferably the stop arm has a laterally offset portion intermediate its length to enable observation of the electrode cutting action over most of its length. In using the i n s w e n t , the endocervical portion is inserted through the vaginal canal and into the endocervical canal of the uterine cervix until the electrode contacts an arca of the ectocervix without colposcopically evident pathology. Current is imparted to the eleclrode and the instrument is advanced into the endocervical canal until the stop a m abuts the ectocervix, after which the instrument is routed one full revolution to cut a conically shaped tissue specimen from the transformation mne of the uterine cervix which is withdrawn with the inshument.
8 Claims, 4 Drawing Sheets

An electro-surgical instrument for excision of a tissue specimen from the transformation mne of the uterine cervix

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FIG I3

FIG 1 4

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1
m'STRUMENT FOR ELECTRO-SURGICAL EXCISOR FOR THE TRANSFORMATION ZONE OF THE UTERINE CERVIX AND METHOD OF USING SAME

5

CROSS REFERENCETo RELATED
APPLICATION tion of my application Ser. No. 08/192,132 filed Feb.4.1994 IO now U.S. Pat No. 5,403,310. BACKGROUND OF THE INVENTION sor,and more particularly, to an elecLro-surgical excisorused for excising a tissue specimen from the transformation zone of the uterine cervix. Cervical inmpithelial neoplasia has been on the increase in reccnt ycm, but successful ablation treatment has been 2D provided by procedures such as elecuocoagnlation, electrodiathenny, cryosurgery, and laser surgery. With such procedures, it is important for the physician to recognize and biopsy invasive cancers to avoid their unintentional ablation. Recently, biopsy specimens of this type of lesion has been zfi successfully obtained by use of wire loop electrodes. Such electrodes allow the lesions and the transformation zone to be removed in their entirety and made available for a pathological analysis. 3 ' In using a loop electrode on the end of a handle. there is typically no guiding support during the excision, As a result, there is a risk of injury to the surrounding tissue which would result in a longer recovery period for the patient. Further, the amount of tissue obtained may vary in amount 35 and definition, leading to difficulties in the pathological analysis. It is an object of the present invention IO provide a novel electro-surgical excisor which permits the complete severance of a controlled tissue specimen in a singlerevolution of the excisor. It is also an object to provide such an electrc-surgical excisor which minimizes the potential for injury to adjacent healthy tissue. It is a further object to provide such an dectrc-surgical 45 excisor which obtains a more defined and controlled amount of cervical tissue, making excision of the lesion and pathological interpretation easier.

The present application is a continuation-in-part applica-

The present invention relates to an electresurgical exci-

15

Generally. the endocenid portion is about 12-22 mm i n length, and a unidirectional stop ann is about 10-20 mm in length, and each bidirectional stop ann is about 7.5-15 m a The stop arm may extend in only one direction or in both directions from the body member. The elwirode is fastened to the endocervical portion at a point spaced inwardly f o its free end, usually about 1-5 rm mm, and to the stop arm at a point spaced inwardly fium its frw end, gcncrally about 1-3 mm for a bidirectional stop ann and 2-5 mm for a unidirectional stop arm. In a preferred embodiment, the stop arm to which the electrode is anached has a latcrally offsct portion intermediate its length to enable viewing of the cervical area which is being cut by the electrode. The offsct portion of thc stop arm may be arcuate or generally V- or U-shaped. In excising a specimen from the transformation zone of the uterine cervix,the endocemid porlion of the instrument is inserted through the vaginal canal and into the endocervical canal of the utenne cervix until the electrode contacts an area of the ectocervix without colposcopically evident pathology. Because of the offset in the preferred slop arm. the physician can observe the placement and cutting action of the clcclrodc over substantiallyits entire length. Current is supplied to the electrode and the inslrument is advanced into the endowical canal until the stop arm abuts thc ectocemix. This CUB into tbe transformation zone of the uterine cervix, aAer which the instrument is rotated one full revolution about its axis with the stop arm abutting the eciocervix to cut a conically shaped tissue specimen from the transformation zone ofthe uterine cervix. The current to the electrode is discontinued, and the instrument and the specimen itre withdrawn from the vaginal canal. If so desired, only a partial revolution may be utilized to cut a wedge-shaped section with thc instrument being withdrawn slowly at the end of the desired arc to cut the opposite cnd of the section. Preferably, the current is of a value to effect both cutting and coagulation, generally to produce power in the range of 5&70 watts. The body portion of the electmde is dimensioned so that the inscrtion results in the body mcmber extending outwardly of the vaginal canal with the endocervical podon m the uterine cervix; in this manner, the inswment is manipulated externally of the vaginal canal. Usually, the ament to the electrodeis discontinued after the advancing step and before the rolating step to allow for preparation for the rotation step. Thmafter, the current is again supplied to the electrode prior to the rotating step. BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a perspective view of an electro-surgical excisor embodying the present invention; F G 2 is a fragmentary plan view of the electrode end I. portion thereof showing the stop ann, elecmode, and endocervical portion, drawn to a scale enlarged from that of F G 1; I. FIG. 3 is a sectional view along the line 3-3 of FIG. 2 drawn to a still enlarged scale; FIG. 4 is a fragmentary side view of the contact end portion of the electro-surgical excisor; FIG. 5 is a diagrammatic view of the electro-surgical excisor being inserted into the vaginal canal and uterine cervix, and showing the excisor mounted in the manipulator of an electro-surgical unit; HG. 6 is a diagrammatic side view of the fragment only illustrated elec~ro-surgical excisor seated in the endocervical

2

SUMMARY OF THE INVENTION
It has now been found that the foregoing and related objects may be readily anained in an electro-surgical instrument for excision of a tissue specimen from the transformation zone of the uterine cervix, and it includes an elongated body member having an endocervical portion at one end, a contact podon at the otber end, and a vaginal portion therebetween. The endocervical portion is inscrtablc into and rotatablc in thc uterine cervix. A stop arm extends substantially at a right angle to the body member at the junclure of the endocervicalportion and the vaginal portion, and a wire electrode extends diagonally from the stop arm to the endocervical portion. The elongated body member is dimensioned to extend outwardly of the vaginal canal when the endocervical portion is inserted into the uterine cervix to allow the instrument to be manipulated externally of the vaginal canal.

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mm, a vaginal poaion 20 of about 80-100, and preferably 90, mm. and a contact portion 18 of about 8-12., and preferably m* XIlllL The ann l2 about 10-20, and is Preferably length. ne anchor bead 26 is Psitioned on the stop arm .12 aboul2-5, and preferably 4, nun from itsfree and theanchor bead 28 is positioned on the endocervicalportion 16 approximately 2-5 mm from its free end. is shown FIGS. n e use of the e l e c b s m d c a l 5-8. Referring first to FIG. 5, the endocervical portion 16 of the excisor is inserted through the vaginal canal 32 and into the endocervical canal 34 of the uterine cervix 36 until the electrode 14 contacts a area of the ectocervix 38 which is n freem O ' cobOscoPicall~ evidentpatholo~.Through Of the manipulator30, current is imparled to the elmuode 14, and the endocenid portion 16 is advanced in the direction shown by the arrow in FIG. 5 into the endocervical canal 34 until the stop arm 12 abuts-the ectocervix 38 as shown in FIG. 6. In this manner, a cut is made i the transformation n zone 40 of the uterine cervix 36 by the electrode 14. Because the stop arm 12is seated stably on the ectocervix 38 and the electrode 14 is taut, the physican has good control of the and the extent of penelration is At this point, current to the dectrode .14 may be discontinued to permii preparation or the next step. Once prepaDETAILED DESCMFTION .OF THE ration is completed, current is again imparted to the elmPREFERRED EMBODIMENT trode 14 and-theexcisor is rotated one full revolution along its axis, shown by the arrows in FIG. 6. Because rotation an electrOo-surgicalexcisor first to FIGS. takes place with the endocervical portion 16 in h e endoccras embodying the present invention is illusmted canal 34, and with the arm l2 abutting the having an elongated body member generally designated by 30 ectocervix 38, the excisor is stabilized, allowing for a the numeral 10,a slop arm 12, and an 14. ?hebody conically shaped tissue specimen 42 to be excised from the member has an endocervical 16 at one tiansformilion 'One 40 Of the uterine cervix 36. thereof, a contact poriion 18 ai ils other end, and a vaginal Once the excision is complete, current is discontinued 10 portion 20 therebetween. The slop ann 12 exlends at a right angle lo the body 35 the electrode 14 and +e excisor is withdrawn from the canal 34 and the vaginal canal32, member 10,intersecting ii at thejuncture of the endocervical the tissue specimen 42 with it. As shown.inFIG. 8, the tissue portion 16 and the vaginal 20. The electrode 14 is specimen 42 be conical in shape providing a defined and formed from a thin wire and diagonally from the conkolled amount of cervical tissue to make pathological stop ann 12 to the endocervical ponion 16. interpretation easier and more reliable. The current As best Seen in F E -3,the body member 10 and stop 40 for the excision is one appropnak for l2 an have formed 'Ore 22 formed Of an il cutting and coagulation and wl typically provide an output conductive material such as stainless steel. This core 22 is power in the range of 5G70 .watts. If so desired, a covered with a coating 24 Of eleclrically wedgeeshapedspecimen may be cut by limiting theextent of such as po!ytetrafluoroethylene, or other insulating synthetic 45 rotation and then slowly the insmmenl to cut resin, except over the contact portion 18. the end of the sectioK l2 an anchor bead 26 Oi has 'Ihe In FIGS. 9 and 10, there is shown an &emate embodi.. conductive material which is in elccrrical contact w$h the .merit of the invention which the stop ann 12 extends in 'Ore 22 and 'paced from free end Of both k c t i o n s from,thebody membq 10. This increases the ann 12.22 and spaced inwardly from the free end of the stop surface of the cervix which the instrument wiu bear ann 12. Similarly, spaced inwardly from the free end of the wh7e allowinga of the arm if it were in endocervical portion 16 is a bead 28 which is in electrical . lo project in only one direction In thisembodiment, each contact with the core 22. The electrode 14 is bonded to the projecting ,ength normally bc 75-10 and the beads 26' and .*ereby electrical with the electrode may be spaced closer to the free end, i.e., about core 22. -55 1-2 mm FIG. 11 illustrates the manner in which the Referring to FIG.4. the uncoated contact porlion 18 is bidirectional stop sea&on opposite sides of the cervical canal to increase stability during rotation. dimensioned to fit a manipulator 30, as shown in FIG..5, of a standard electro-surgical unit (not shown) so that current next to the .embo&,,ent of mGS. 1215, this will flow therethrough to the electrode 14. excisor has a stop arm 120 which has a laterally offset As Seen in FIG. 5. the body member 10 Of thd 60 portion 40 of arcuate configuration so that most of the stop elecuo-surgical excisor is dimensioned so that the contact ann 12 is offset from the longitudinal plane extending Portion.18 is OutwardY of the Canal 32 through the electrode 14 and body member 10. As a result, when the endocervical portion 16 is inserted into the the physician can see most of the cerrical area which is endocervical canal 34 of the uterine cervix 36. being cut by the electrode and which would othenvise be . . In a working embodiment, the elongated body member 10 65 obscurcd by the slop ann 1 . h However, the stop ann 12a is about 12e140, and preferably 130, mm in length, wt an ih seats about the ectocervix 38, and the excisor is stabilized endocervical panion 16 of about 18-22, and preferably 20, and limited as to the amount of penetration.
canal with arrows showing rotation of,theexcisor for tissue excision; FIG. 7 is a diagrammatic view similar to FIG. 6 after the excisor and excised tissue specimen have been withdraw; 5 FIG. 8 is a perspective view of the tissue specimen after removal f o the electro-surgical excisor. rm . FIG. 9 is a perspective view of an alternate embodiment of the invention in which .the stop arm extends in both dmtions from the body; FIG. 10 is a hgmentary sectional view of the embodiment of FIG. 9 drawn to an enlarged scale; the manner FIG. 6 "G. 11 is a view jn which the elements of the bidirectional slop Seat 15 about the cervix to increase stability; FIG- 12 is a PemPectiVCVieW of a P T e f e d embodiment . . of the excisor of the present invention; FIG. 13 is a fragmentary side elevational view of the end portion of the excisor of FIG. 12; . u) FIG. 14 is a bottom end view thereor; and FIG. 15 is a fragmentary sectional view of the excisor along the line 1 L 1 5 of FIG. 13.

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Electro-surgical exdsors having the electrode positioned at varying angles, as appropriate for different clinical situations, may be fabricated by altering the position of anchor 6 bead 2 on stop arm 12 andlor the position of anchor bead '28on endocervical portion 16. Thus, it can be. s e from the foregoing detailed specifien cation and attached drawings that the novel electro-surgical excisor of the present invention enables complete severance tissue in a single revolution of the excisor of the ~ervical while preventing injury to the adjacent healthy tissue. Ad&- 10 tionally. use of the excisor enables the excisor of a defined and controlled amount of cervical tissue, making excision of the lesion and pathological interpretation easier. No special equipment is necessary for the excisor of the present invention which may be utilized in existing electro-surgical appa- 15 ratus. Having thus described the invention, what is claimed is: 1 An elcctro-surgical insmmcnt for excision of a tissue . specimen from a transformation zone of a uterine cervix by 20 insertion through a vaginal canal comprising: (a) an elongated body mernbcr having two ends with an endocervical portion adjacent one end, a contact porlion adjacent a second end, and a vaginal portion therebetween, said endocervical portion being insert25 able into and rotatable in uterine cervix; @) a stop arm extending substantially at a right angle to . said body member at a juncture of said endocervical poxtion and said vaginal portion, said slop arm having a latcrally offsct portion intcrmcdiate its length; and 3o (c) a wire electrode extending diagonally from adjacent an outer end of said stop arm to said endocenrical portion, said offset portion of said slop arm enabling visual observation of a cervical area to be cut by the wire electrode. 35 2. The electro-surgical instrument in accordance with claim 1wherein laterally offset portion of said stop arm is of arcuate configuration. 3 The electre-surgical instrument in accordance with . claim 2 wherein the outer end of said stop arm is the outer 40 end of said offset portion of arcuate configuration 4. The electro-surgical instfument in accordance w t ih claim 1 wherein said elongated body member is dimensioned to extend outwardly of the vaginal canal when the endocervical portion is inscrtcd into the associated uterine 6 cervix to allow said instrument to be manipulated externally of the vaginal canal.

6
5. The elecm-surgical inswment in accordance with

.

claim 1 wherein said electrode is faskned to said endocervical portion at a p i n t spaced inwardly from said one end of said body member. 6. A method for excising a specimen f o a ttansformarm tion zone of a uterinecervix of a patient by insertionlhrough a vaginal m l mmpn'sing steps of: a the an clectro-surgid (a) an elongated body member having two ends with an cndocervical portion adjacent one end, a contact portion adjaccnt a second end, and a vaginal portion therebetween, a stop arm extending substantially at a right angle to said body member at a juncture of said endocervicalportion and said vaginal portion, said stop arm having a laterally offset portion intermediate its lenglh and a wire electrode extending diagonally f o rm adjacent a0 outer end of said stop a m to said endocerr vical p h o n ; (b) inserting said endocervical portion of said instrument through the vaginal canal and inlo the endocervical canal of the uterine cervix of a patient until said electrode contacts an area of ectocervix without colposcopically evident pathology; (c) impaning current to said electrode; (dl advancing said instrument into said endocervical until said stop arm abuts said ectocervix, said laterally offsct portion of said stop arm enabling visual observation of cervical area being cut by the electrode, thereby cutting into the transformation zone of said uterine cervix with said electrode; (e) rotating said instrument about its axis with said stop arm abutting said ectocervix to cut a tissue specimen from said transformation zone of said uterine cervix; (0 discontinuing current to said electrode; and (9) withdrawing said instrument and said specimen from the vaginal canal. 7.The method for excising a specimen in accordance with claim 6 wherein the cument imparting step involves impaning a current of a value to effect both cutting and coagulation. 8. The method for excisinga specimen in accordance with claim 6 wherein said current produces power in a range of 50-70 wans.

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