Surgery – Instruments – Electrical application
Reexamination Certificate
1999-09-10
2001-09-25
Peffley, Michael (Department: 3739)
Surgery
Instruments
Electrical application
C606S049000, C128S898000
Reexamination Certificate
active
06293944
ABSTRACT:
This invention relates to an electrosurgical electrode for electrosurgical scierotherapy, i.e., the treatment of varicose veins of a patient.
BACKGROUND OF THE INVENTION
Reference is made to our U.S. Pat. No. 5,695,495, whose contents are herein incorporated by reference, which describes an electrosurgical electrode for scierotherapy. The latter replaces an earlier form of sclerotherapy which involves introducing a sclerosing agent, be it physical, chemical or mechanical, into a vessel to produce sclerosis. The advantage of our patented electrosurgical electrode is that it enables physicians to offer to patients a treatment that is virtually non-invasive and non-surgical, efficiently performed, easily learned by the physician and thus performed at a significantly reduced price, and requiring less patient follow-up with superior results compared to non-electrosurgical procedures.
The common manner to implement this new procedure and in a sense a possible disadvantage is that the precise vein to be treated is first identified by placing the hollow needle of a hypodermic syringe into the skin/vein interface, and withdrawing the plunger. If blood is back drained into the syringe barrel, then the practitioner by viewing the blood knows the syringe needle is in the vein to be treated. Once the vein is thus identified, the needle is removed and the patented insulated needle electrode is placed carefully trying to locate the same needle or hole site formed by the syringe needle as well as depth location of where the vein was. This can be a difficult and tedious task and often results in losing the previously identified vein. The procedure then has to be repeated. The time necessary to find the correct vein can be consuming.
SUMMARY OF THE INVENTION
An object of the invention is an improved surgical procedure for the treatment of varicose veins.
Another object of the invention is an improved instrument for the electrosurgical treatment of varicose veins.
A further object of the invention is an improved electrosurgical instrument to accomplish the end result of collapsing the offending varicose vein.
We have invented a novel instrument for use in electrosurgical sclerotherapy. Essentially, the new instrument combines a hypodermic needle syringe with means connected to the needle for selectively applying to the needle radio-frequency (RF) electrosurgical currents. In operation, the hypodermic needle is inserted into the vein to be treated and the plunger withdrawn to see whether blood is back drawn into the syringe barrel. If blood is detected, then the practitioner simply activates the electrosurgical apparatus and the resultant application of the RF electrosurgical currents quickly collapses the vein. As will be evident, the needle need not be withdrawn after the blood is detected, with the result that no problem arises of trying to locate a pin hole previously produced by a needle.
It will be noted that
FIG. 4
of the referenced patent describes an embodiment in which the needle used was a cannula. However, the specification makes clear that the needle bore is not used in the sclerotherapy described in the patent. At the time that the patent specification was drafted and while it was prosecuted, it never occurred to us to attach a syringe to the needle for any purpose. In fact, using either the embodiment of a solid needle or a hollow needle for attachment to a conventional electrosurgical handpiece made it impossible to attach a hypodermic syringe to the needle. The needle with the cannula was only mentioned as it seemed at the time that such needles might be more readily purchased than a solid needle. It wasn't until after the referenced patent was issued that the problems associated with its use came to our attention and triggered this invention.
As is described in the issued patent, the needle part of our electrosurgical syringe, except for the tip which is inserted into the vein to be treated, is insulated to prevent undesired electrical discharges to tissue surrounding the vein to be treated.
The procedure using our novel syringe electrode is based on superficial damage or destruction of the tissues lining the wall of the vein, causing collapse and obstruction of the vein. The electrode of the invention is configured to enable the active tip to reach and electrosurgically damage or destroy the vein lining with minimal damage to the surrounding tissue. The needle electrode is moved through the vein while it remains energized and then removed to determine whether the desired effect has been realized or a retreatment may be necessary during the same patient visit.
In a preferred embodiment, the needle part of our novel electrode is characterized by a bare active sharpened tip of a fine needle whose portions extending beyond the exposed tip are completely insulated by a thin electrically-insulating coating. A family of needle electrodes can be provided of increasing gauges to fit easily within large, medium, or small varices. Some medial and lateral fanning of the active point may be desirable while moving the needle, including preferably withdrawing the needle, to contact as much of the tissue lining the veins being treated as possible. The portions of the needle adjacent to the tip are made insulating to avoid excessive heating and to concentrate the high frequency currents at the needle tip. The electrosurgical procedure using the needle electrode has the important advantages of concentrating the currents causing the tissue damage at the tissue required, with minimal damage to surrounding tissue, in a relatively fast procedure, and with little pain or trauma for the patient.
It is preferred that the electrosurgical currents used be above 2 MHz, and preferably above 3 MHz. At these high frequencies, commonly referred to as radiosurgery, destruction is accomplished by volatilizing intracellular fluids at the point of the transmitting electrode contact which is primarily responsible for only small lateral heat spread and thus less damage to neighboring cell layers.
REFERENCES:
patent: 3301258 (1967-01-01), Werner et al.
patent: 4269174 (1981-05-01), Adair
patent: 4483338 (1984-11-01), Bloom et al.
patent: 4920982 (1990-05-01), Goldstein
patent: 5336222 (1994-08-01), Durgin, Jr. et al.
patent: 5403311 (1995-04-01), Abele et al.
patent: 5437664 (1995-08-01), Cohen et al.
Ellman Alan G.
Garito Jon C.
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