1. Technical Field
The present invention relates generally to electrosurgical coagulators and, more particularly, to an electrosurgical suction coagulator having improved thermal insulation between the active electrode and adjacent tissue.
2. Background of Related Art
The coagulation of bleeding blood vessels and tissue using electrically conductive suction tubes is a technique which has been widely used for some time. Typically, a combination electrosurgery and suction device is employed in surgery wherever excessive blood must be removed from the bleeding site in order to facilitate hemostasis of any bleeding vessels. More particularly, during any given surgical procedure, several layers of tissue usually must be penetrated to reach the operative field. When resecting an organ, for example, a gallbladder, the tissue surrounding the organ must be penetrated and dissected before the organ can be removed. The tissues being dissected, however, often contain blood vessels, nerves, lymph vessels, and the like, which should not be severed. The technique of blunt dissection is often used to prevent unnecessary damage caused by severing these vessels or nerves.
Blunt dissection, as opposed to sharp dissection, involves the use of a blunt surface to break through the tissue, thereby preventing the damage and bleeding caused by lasers and scalpels, the tools of sharp dissection. Hard surgical sponges, generally known as peanuts or Kittner sponges, or a surgeon's fingers are often used as blunt dissectors. A peanut is a tightly wound ball of absorbent material, such as gauze or other woven cotton, which is typically gripped with forceps and acts to abrade the tissue being dissected so that the dissection can be performed by either pulling on the tissue or by forcing the peanut through the tissue.
Laparoscopy, surgery performed through several small incisions made in the body rather than through a single large opening, has become the preferred method of performing certain procedures due to the reduced trauma and risk of infection as compared to normal, open surgical procedures. As a result, the use of conventional blunt dissectors, such as the peanut, during laparoscopic procedures presents many significant drawbacks. For instance, peanuts, being secured only by forceps, can become loose in the body. Further, the view of the operative field often becomes obstructed by pieces of tissue, blood and other bodily fluids produced during blunt dissection, necessitating the immediate need for both irrigation and aspiration of the operative field. Since it is undesirable to create additional incisions, the dissection must be stopped, the dissector must be removed, and all irrigator and/or aspirator must be inserted to remove the fluid and debris.
The use of electrical energy including radiofrequency and microwave energy and, in particular, radiofrequency (“RF”) electrodes or microwave antennae for ablation of tissue in the body or for the treatment of pain is known. For example, electrosurgery is a technique of using alternating current electrical signals in the approximately 200 kHz-3.3 mHz range that are generated by a source of electrosurgical energy, such as an electrosurgical generator, in connection with surgical instruments, to cut or coagulate biologic tissue endogenically. This electrosurgical signal can be a sinusoidal waveform operating in a continuous mode at a 100% duty cycle, or pulse modulated at a duty cycle of less than 100%. Typically, electrosurgical signals are operated at 100% duty cycle for maximal cutting effect, and are pulse modulated at duty cycles ranging from 50% to 25% for less aggressive cutting, or, at a substantially lower duty cycle of approximately 6%, for coagulating. The electrosurgical carrier signal may also be varied in intensity. The electrosurgical signal is applied to the patient via electrodes in either monopolar mode, or bipolar mode. In monopolar mode, the active electrode is the surgical instrument at the surgical site, and the return electrode is elsewhere on the patient, such that the electrosurgical signal passes through the patient's body from the surgical site to the return electrode. In bipolar mode, both the active and return electrodes are at the surgical site, such as with an instrument having an array of electrodes, so that the electrosurgical signal passes only through the tissue situated between the RF electrodes of the instrument.
Electrosurgical suction coagulators which both coagulate and dissect tissue have also been available for some time. Generally, these devices include a shaft formed from a conductive suction tube electrode having an electrically insulating coating over all but a most distal portion of the tube, so that the distal portion forms a generally annular ablating electrode. The shaft may be formed of malleable materials to enable a surgeon to bend the shaft to a desired shape. The distal end can be used as a blunt dissection device and/or a blunt coagulator. A suction source is attached to a proximal portion of the tube for evacuating excess fluid and debris from the surgical site through the distal end of the tube. The electrode is operably coupled to a source of electrosurgical energy, such as an electrosurgical generator.
The described electrosurgical suction coagulators may have drawbacks. In particular, heat conducted from the suction tube electrode to the outer surface of the shaft may cause the surface of the shaft to reach temperatures of 60° C. or greater. This may be a concern during surgical procedures, such as an electrosurgical adenotonsillectomy, where the shaft of a suction coagulator may be in proximity to, or in contact with, anatomical structures unrelated to the procedure, such as the uvula or the oral commissure. The elevated shaft temperature may have undesirable effects on such unrelated anatomical structures, including uvular edema and erythema of the oral commissure area. An electrosurgical suction coagulator which avoids or minimizes such undesirable effects would be a welcome advance in the art, particularly when such benefits are realized in a rugged, reliable, and relatively simple design.
The present disclosure provides an electrosurgical suction coagulation system having, and related methods for, improved control of the shaft surface temperature. In particular, embodiments in accordance with the present disclosure may provide passive thermal insulation of the shaft, active cooling of the shaft, and may advantageously include combinations of passive insulation and active cooling, as will be described hereinbelow.
In an embodiment in accordance with the present disclosure, an electrosurgical suction coagulator includes a shaft formed from a conductive suction tube, an outer dielectric sheath covering over all but a distal electrode portion of the tube, and has disposed therebetween an insulating layer formed from braided material having low thermal conduction, for example, braided polymeric or ceramic fibers. The braided material may be configured as a tubular braided sheath or a spiral wrapped layer. The combination of air voids in the braided layer and the low thermal conductive properties of the braided insulating material may reduce thermal conduction from the metallic suction tube to the exterior surface of the instrument. In envisioned embodiments, an insulating layer may be formed from woven material.
In embodiments, the shaft of a suction coagulator in accordance with the present disclosure may be straight or contoured. The shaft may additionally be formed from malleable materials to enable a user, for example, a surgeon or clinician, to bend the shaft to a desired shape. A suction coagulator in accordance with the present disclosure may include a handle. The handle may include at least one control for activating the electrosurgical energy and/or evacuation (i.e., suction).
In envisioned embodiments, a suction coagulator includes thermal isolation between a suction tube and a distal electrode tip, formed from, for example without limitation, ceramic insulating material and/or polymeric insulating material. The tip may be operably coupled to the suction tube by at least one electrically conductive element, such as a wire. Additionally or alternatively, a distal electrode tip may be operably coupled to a source of electrosurgical energy by at least one of a wire and the suction tube.
In another envisioned embodiment, an insulating layer disposed between the tubular electrode and dielectric sheath is formed from closed-cell foam material, for example, closed cell foamed polyurethane. Additionally or alternatively, the outer surface of the dielectric sheath may include a closed cell foam covering disposed thereupon, which may further reduce thermal conduction from the electrode to adjacent tissue.
In embodiments, the outer surface of the dielectric sheath may include an open cell foam covering disposed thereupon. During use, the open foam layer may be infused with a fluid, for example, water or saline solution, which may increase the thermal mass of the covering and provide a cooling effect, thereby reducing surface temperature of the instrument shaft.
In embodiments, an electrosurgical generator in accordance with the present disclosure may be configured to limit the activation time of a suction coagulator, and/or enforce minimum quiescent times between activations. During use, the electrosurgical generator may determine whether the activation time has exceeded a threshold, and in response thereto, deactivate the generator. Additionally, reactivation of the generator may be inhibited until the expiration of a “rest” time period, or until a user input is received by the generator.
The instrument may be configured to provide instrument identification information to the generator, for example, an optical code (i.e., barcode), an RFID tag, or other suitable machine- or human-readable encodings. The generator may use such instrument identification information to determine corresponding activation and quiescent time parameters for the instrument.
In an envisioned embodiment, a suction coagulator in accordance with the present disclosure includes a sensor that is adapted to sense the surface temperature of the instrument. The sensor may be operably coupled to an electrosurgical generator. The electrosurgical generator may be configured to respond to the sensed temperature, by, for example, limiting the activation time, altering the electrosurgical signal, and/or deactivating the generation of the electrosurgical signal. In embodiments, the generator may additionally or alternatively respond to at least one parameter related to the sensed temperature of the instrument, for example, a change in temperature of the instrument and/or a rate of change of temperature of the instrument.
In embodiments, an electrosurgical generator in accordance with the present disclosure may be configured to issue a prompt (e.g., an alarm) to the user. A prompt may be issued to advise the user to pause the activation of the instrument. In envisioned embodiments, a prompt may be issued to advise the user to replenish depleted fluids in, for example, a fluid-infused open foam cover. Such a prompt may be based upon, for example, cumulative activation time, instrument identity, and/or the surface temperature of the instrument. The alarm may be automatically cleared after a predetermined time period. Additionally or alternatively, the alarm may be cleared by a user input received by the electrosurgical generator.
Other embodiments according to the present disclosure are envisioned wherein an electrosurgical suction coagulator includes a conduit for introducing a coolant, for example, saline solution, to the distal tip of the instrument during use. The conduit may be configured to “drip” coolant onto an electrode disposed at the distal end of the instrument. The conduit may be in fluid communication, preferably at the proximal end of the instrument, to a source of cooling fluid, for example, a saline bag, that may provide cooling fluid via any suitable manner of delivery, for example, by gravity feed, pump, or pressurized vessel.
In other envisioned embodiments, en electrosurgical suction coagulator according the present disclosure includes a coolant jacket that may be formed by a conduit included in the instrument. Coolant is introduced into the coolant jacket, preferably at the proximal end of the instrument, flows through the conduit towards the distal tip region of the instrument, and exits the instrument. The coolant jacket may be configured to cool the tip and/or the surface of the instrument.
The above and other aspects, features, and advantages of the present disclosure will become more apparent in light of the following detailed description when taken in conjunction with the accompanying drawings in which:
Particular embodiments of the present disclosure will be described herein with reference to the accompanying drawings. As shown in the drawings and as described throughout the following description, and as is traditional when referring to relative positioning on an object, the term “proximal” refers to the end of the apparatus that is closer to the user and the term “distal” refers to the end of the apparatus that is further from the user. In the following description, well-known functions or constructions are not described in detail to avoid obscuring the present disclosure in unnecessary detail.
With reference to
Distal end 124 of shaft 120 includes an exposed tubular electrode 125 for delivering electrosurgical energy to tissue, the electrode 125 having a conduit 126 defined longitudinally therethrough for providing suction to a surgical site. Conduit 126 is in fluid communication with vacuum source 150 via lumen 155.
In an embodiment, handle 115 may include a control 130 which may be a handswitch for controlling the application of electrosurgical energy, i.e., activation and deactivation of an electrosurgical signal. Handle 115 may include an additional or second control 131 for controlling the application of suction to the surgical site. In embodiments, control 131 may be operably coupled to a valve (not shown) that may be disposed within handle 115, shaft 120, vacuum source 150, and/or lumen 155. In other envisioned embodiments, control 131 may be operably coupled to a regulator, motor control, or other suitable manner of vacuum control.
Turning now to
In another envisioned embodiment best illustrated in
In yet another envisioned embodiment best illustrated in
Turning to
In
In
Turning now to
The described embodiments of the present disclosure are intended to be illustrative rather than restrictive, and are not intended to represent every embodiment of the present disclosure. Further variations of the above-disclosed embodiments and other features and functions, or alternatives thereof, may be made or desirably combined into many other different systems or applications without departing from the spirit or scope of the disclosure as set forth in the following claims both literally and in equivalents recognized in law.
Number | Name | Date | Kind |
---|---|---|---|
2808833 | August | Oct 1957 | A |
3630203 | Sellinger et al. | Dec 1971 | A |
3828780 | Morrison, Jr. | Aug 1974 | A |
3838242 | Goucher | Sep 1974 | A |
3971383 | Van Gerven | Jul 1976 | A |
3974833 | Durden, III | Aug 1976 | A |
4869715 | Sherburne | Sep 1989 | A |
4932952 | Wojciechowivz, Jr. | Jun 1990 | A |
4949734 | Bernstein | Aug 1990 | A |
5084045 | Helenowski | Jan 1992 | A |
5277696 | Hagen | Jan 1994 | A |
5312401 | Newton et al. | May 1994 | A |
5364395 | West, Jr. | Nov 1994 | A |
5462521 | Brucker et al. | Oct 1995 | A |
5472441 | Edwards et al. | Dec 1995 | A |
5520685 | Wojciechowica | May 1996 | A |
5647871 | Levine et al. | Jul 1997 | A |
5718702 | Edwards | Feb 1998 | A |
5730742 | Wojciechowicz | Mar 1998 | A |
5807395 | Mulier et al. | Sep 1998 | A |
5814044 | Hooven | Sep 1998 | A |
5848986 | Lundquist et al. | Dec 1998 | A |
5944713 | Schuman | Aug 1999 | A |
5951546 | Lorentzen | Sep 1999 | A |
5951548 | DeSisto et al. | Sep 1999 | A |
5957882 | Nita et al. | Sep 1999 | A |
5968042 | Ernster | Oct 1999 | A |
6027501 | Goble et al. | Feb 2000 | A |
6033375 | Brumback | Mar 2000 | A |
6039730 | Rabin et al. | Mar 2000 | A |
6053912 | Panescu et al. | Apr 2000 | A |
6063081 | Mulier et al. | May 2000 | A |
6117134 | Cunningham et al. | Sep 2000 | A |
6179803 | Edwards et al. | Jan 2001 | B1 |
6190381 | Olsen et al. | Feb 2001 | B1 |
6379348 | Onik | Apr 2002 | B1 |
6379350 | Sharkey et al. | Apr 2002 | B1 |
6406476 | Kirwan, Jr. et al. | Jun 2002 | B1 |
6458126 | Doyle | Oct 2002 | B1 |
6595990 | Weinstein et al. | Jul 2003 | B1 |
6770070 | Balbierz | Aug 2004 | B1 |
6849073 | Hoey et al. | Feb 2005 | B2 |
6911029 | Platt | Jun 2005 | B2 |
7169148 | O'Halloran | Jan 2007 | B2 |
7537594 | Sartor | May 2009 | B2 |
7572257 | Whayne et al. | Aug 2009 | B2 |
7588057 | Bentley | Sep 2009 | B2 |
20020049438 | Sharkey et al. | Apr 2002 | A1 |
20030065316 | Levine et al. | Apr 2003 | A1 |
20030181904 | Levine et al. | Sep 2003 | A1 |
20040082951 | O'Halloran | Apr 2004 | A1 |
20040193150 | Sharkey et al. | Sep 2004 | A1 |
20040260280 | Sartor | Dec 2004 | A1 |
20050187544 | Swanson et al. | Aug 2005 | A1 |
20070118144 | Truckai et al. | May 2007 | A1 |
20070233148 | Truckai et al. | Oct 2007 | A1 |
Number | Date | Country |
---|---|---|
2460481 | Dec 1974 | DE |
2429021 | Jan 1976 | DE |
3045996 | Jul 1982 | DE |
3710489 | Nov 1987 | DE |
4139029 | Jun 1993 | DE |
4326037 | Feb 1995 | DE |
9117019.2 | Apr 1995 | DE |
19537897 | Mar 1997 | DE |
9117299 | Apr 2000 | DE |
19848784 | May 2000 | DE |
29724247 | Aug 2000 | DE |
0186369 | Jul 1986 | EP |
0447121 | Sep 1991 | EP |
0612535 | Aug 1994 | EP |
0956827 | Nov 1999 | EP |
1050279 | Aug 2000 | EP |
1050277 | Nov 2000 | EP |
1082945 | Mar 2001 | EP |
1090597 | Apr 2001 | EP |
1090599 | Apr 2001 | EP |
1127551 | Aug 2001 | EP |
1199037 | Apr 2002 | EP |
1199038 | Apr 2002 | EP |
1293171 | Mar 2003 | EP |
1199037 | Jul 2003 | EP |
1199038 | Jul 2003 | EP |
1323384 | Jul 2003 | EP |
1323384 | Jan 2004 | EP |
1561430 | Aug 2005 | EP |
1090598 | Sep 2005 | EP |
1570798 | Sep 2005 | EP |
1595507 | Nov 2005 | EP |
1656900 | May 2006 | EP |
1645234 | Dec 2006 | EP |
1602337 | Dec 2007 | EP |
1340509 | Sep 1963 | FR |
2235669 | Jan 1975 | FR |
1014995 | Dec 1965 | GB |
L014995 | Dec 1965 | GB |
1222243 | Feb 1998 | GB |
61-159953 | Jul 1986 | JP |
1438745 | Nov 1988 | SU |
9113593 | Sep 1991 | WO |
9303678 | Mar 1993 | WO |
9420032 | Sep 1994 | WO |
9627337 | Sep 1996 | WO |
9639086 | Dec 1996 | WO |
9711647 | Apr 1997 | WO |
9843264 | Oct 1998 | WO |
9915091 | Apr 1999 | WO |
0162333 | Aug 2001 | WO |
0164122 | Sep 2001 | WO |
0247568 | Jun 2002 | WO |
02058762 | Aug 2002 | WO |
2004010883 | Feb 2004 | WO |
2004045436 | Jun 2004 | WO |
2004073753 | Sep 2004 | WO |
2005016142 | Feb 2005 | WO |
2005060849 | Jul 2005 | WO |
Number | Date | Country | |
---|---|---|---|
20100023008 A1 | Jan 2010 | US |