Surgery – Instruments – Electrical application
Reexamination Certificate
1996-12-09
2001-03-06
Dvorak, Linda C. M. (Department: 3739)
Surgery
Instruments
Electrical application
C606S041000, C606S049000
Reexamination Certificate
active
06197025
ABSTRACT:
BACKGROUND OF THE INVENTION
1. Field of the Invention
The invention relates generally to an electrode having a slider element adapted for use with an endoscope for tissue ablation and more particularly relates to an electrode having a grooved slider for use in performing procedures, such as, for example, in the genitourinary tract on soft tissue, including bladder and prostrate, for hemostasis, incision, excision and ablation or in performing gynecological procedures such as endometrial ablation.
2. Description of the Prior Art
Use of resectoscopes to treat tissue in the genitourinary tract is well known. Typical of such resectoscopes are the devices disclosed in U.S. Pat. Nos. 5,151,101 and 4,955,884.
Resectoscopes used for transurethral resection of the prostrate (TURP) have four elements, a resectoscope sheath, sometimes referred to as a sheath or an outer sheath, a working element, an electrode and a telescope. The electrodes are operatively connected to a working element and a telescope is slideably inserted through the working element and into position along side of the electrode. Certain electrodes include an electrode stabilizer which is adapted to receive the telescope. The so assembled working element, telescope and electrode are removable inserted into the sheath to perform a procedure.
In a typical urological procedure, the outer sheath, having an obturator and telescope inserted therein, is visually passed through the urethra to the vicinity of the prostrate and/or bladder neck. The electrode, which is also known as a resectoscope electrode, is typically in the form of a cutting loop located at the distal end of an electrode lead member.
An electrosurgical current, which may be either a coagulation current, a cutting current or some blend thereof is applied to the cutting loop. The energized cutting loop is moved across and cuts the tissue being treated. The cutting loop can also be used to coagulate the wound. In urological procedures, the peak voltage of the electrosurgical cutting currents are typically in the range of 225 volts to about 250 volts at a power level of between about 120 watts to about 200 watts.
A resectoscope electrode having a stabilized cutting loop for a resectoscope is described in U.S. Pat. No. 4,917,082.
The resectoscope electrode described in U.S. Pat. No. 4,917,082 is adapted for use with a urological endoscope or resectoscope. The electrode comprises an electrode lead, an electrode end and an electrode stabilizer. U.S. Pat. No. 4,917,082 discloses that the electrode may take the form of a coagulating electrode, knife electrode, retrograde knife electrode, punctate electrode or roller electrode having a smooth exterior surface.
Continuous flow resectoscopes which utilize a cutting loop electrode for urological procedures are well known in the art and an example of a continuous flow resectoscope is disclosed in U.S. Pat. No. 3,835,842.
An article entitled “THE USE OF THE RESECTOSCOPE IN GYNECOLOGY” by Richard A. Auhll which appeared at pages 91 through 99 of the Oct. 11, 1990 issue of Biomedical Business International (the “Auhll Reference”) disclosed the use of a uterine resectoscope system in the form of a continuous flow resectoscope using an electrosurgical electrode for performing intrauterine procedures.
The Auhll Reference discussed three electrode structures, namely: (1) an electrosurgical cutting loop to treat fibroid tissues; (2) a roller ball having a smooth exterior surface for endometrial ablation (which is cauterization of the endometrium); and (3) electrosurgical needle to cut through and destroy tissue producing intrauterine synechia. In gynecological procedures, the voltage of the electrosurgical cutting currents are typically in the range of 225 volts to about 250 volts at a power level of between 60 watts and 100 watts.
In order to increase the efficiency of treatment of the prostrate tissue generally, and the treatment of benign hypertrophy of the prostrate (BPH) in particular, several new procedures and devices have been developed. These procedures and devices include the use of a Nd:YAG laser for the coagulation and vaporization of prostate tissue generally referred to as abdominal tissue. In order to use Nd:YAG lasers for treatment of BPH, optical fibers capable of deflecting a Nd:YAG laser energy beam about 70° to about 90° to the axis of the optical fiber (generally known as side-firing fibers) have been developed.
Use of a direct contact laser fiber is discussed in an article entitled “TRANSURETHRAL EVAPORATION OF PROSTATE (TUEP) WITH ND:YAG LASER USING A CONTACT FREE BEAM TECHNIQUE: RESULTS IN 61 PATIENTS WITH BENIGN PROSTATIC HYPERPLASIA” by Perinchery Narayan, M.D., George Fournier, M.D., R. Indudhara, M.D., R. Leidich, M.D., K. Shinohara, M.D. and Alex Ingermann, M.D. which appeared at pages 813 through 820, in the June, 1994, Volume 43, Number 6, Issue of Urology (the “Narayan et al. Reference”). The Narayan et al. Reference discusses the use of laser surgery for BPH as a promising alternative to traditional TURP. The Narayan et al Reference discloses that in prostate surgery tissue evaporation referred to as Transurethral Evaporation of Prostate Tissue (“TUEP”) was achieved by holding the laser fiber in contact with the area to be treated. The TUEP was performed using an Ultraline Laser Fiber manufactured by Heraeus LaserSonics, Milpitas, Calif. The Ultraline Laser Fiber uses a 600 &mgr;m internal reflector fiber covered by a quartz glass cap that reflects the Nd:YAG beam at 80 degrees to the fiber axis. This fiber transmits a high-power density beam (spot size of 700 &mgr;m and divergence of 17 degrees, giving a power density at 60 watts to 80 watts of 15,600 to 21,231 W/cm
2
) 1 mm from the fiber tip. A 23 French cystoscope (CIRCON ACMI, Stamford, Conn.) equipped with an 8 French laser bridge and a continuous flow system was used for the procedure.
The results as state in the Narayan et al. Reference was as follows:
“ . . . Tissue evaporation was achieved by holding the laser fiber in contact with the area to be treated, and by dragging at a rate of 1 cm/20 seconds of laser energy delivery. At the beginning of each furrow dragging was commenced one bulling was seen indicating tissue evaporation. Dragging the fiber at a rate of 1 cm/20 seconds resulted in a furrow 5 to 7 mm deep with a 3 to 4 mm rim of coagulated tissue immediately next to it.”
Another known prior art device for treatment of prostate tissue was presented at a poster session at the Society of Minimal Invasive Therapy (“SMIT”) on Nov. 5, 1993. The poster session was entitled “TRANSURETHRAL VAPORIZATION OF THE PROSTATE (T.V.P.): NEW HORIZONS” by Irving M. Bush, M.D., Edward Malters, M.D. and Jan Bush, R.N. (the “Bush et al. Reference”) disclosed the use of an improved scored ball loop produced by CIRCON ACMI Division of Circon Corporation, assignee of the present patent application, with a continuous flow resectoscope for providing transurethral desiccation (vaporization) of the prostrate.
The Bush et al Reference states as follows:
“T.U.D (transurethral desiccation of the prostate) was first described in 1874 by Bottini. Since 1966 we have used this visually controlled exact vaporization of the prostate in over 500 men with benign hypertrophy, cancer and bladder neck disease.
In the present method (T.V.P., transurethral vaporization of the prostate) a grooved ball electrode and pure electrosurgical cutting current is used to sculpt out the prostatic bed. T.V.P. has the advantage that it causes little or not bleeding, fluid absorption or electrolyte imbalance. Since the residual desiccated tissue (adequate for pathologic review) is removed at the end of the procedure, there is no slough or delayed bleeding (open vessels are closed without retraction). The patient can leave the hospital, voiding (76%) within the 23 hour observation time in most instances. A new improved scored ball loop (A.C.M.I.) to be used with a continuous flow resectoscope has become available.
T.V.P. is a short procedure without sphincter damage which preserves antegrade
Grossi Benedetto
Muller Richard P.
Quint Robert
Circon Corporation
Dvorak Linda C. M.
Ganz, Esq. Bradley M.
Ruddy David M.
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