Electrosurgery irrigation primer systems and methods

Information

  • Patent Grant
  • 9095358
  • Patent Number
    9,095,358
  • Date Filed
    Friday, December 21, 2012
    11 years ago
  • Date Issued
    Tuesday, August 4, 2015
    8 years ago
Abstract
Systems and methods are provided for priming or purging an electrosurgical fluid irrigation system. The electrosurgical system can include a high frequency power supply, a fluid delivery system, a handheld device having one or more electrodes, and one or more connectors for connecting the handheld device to the fluid delivery system and the RF generator. The electrosurgical system may be configured to deliver RF current and irrigation fluid until a threshold current level is detected, which is indicative of a continuous flow of fluid at the electrode and purging completion. The systems and methods of purging an electrosurgical system may further include dynamically controlling an RF output and fluid delivery system in accordance with varied parameters of detected threshold current levels.
Description
BACKGROUND

Some electrosurgical systems require the introduction of an irrigation fluid in order to produce a desired effect at the surgical site. Such systems may include an RF generator, a disposable hand piece or device connected to the generator and a source of irrigation fluid. Prior to use, these systems must be set up and part of the set up process requires that the system for delivering fluid be purged such that fluid can be supplied immediately when an RF output is activated.


Typically, the priming, or purging, process in existing systems requires efforts of coordination between the surgical staff positioned in a sterile field who only handle the sterile disposable device, and other operating personal positioned outside of the sterile field and who control the fluid delivery system on the generator in order to perform the purging process. This coordinated effort can be both distracting to a number of personnel in the operating room, and may also delay the start of the surgical procedure.


Some systems, which integrate a purging process into the generator, typically work by allowing fluid delivery for a fixed period of time. This timed delivery, however, is only approximate, and usually requires the attention of the surgeon to completely purge the device.


Accordingly, there is a need for improved and more efficient electrosurgery purging systems and methods.


BRIEF SUMMARY

In certain embodiments, electrosurgical systems are provided. An electrosurgical system can include a high frequency power supply, (e.g., an RF generator), a fluid delivery system, a handheld device having one or more electrodes, and one or more connectors for connecting the handheld device to the fluid delivery system and to the RF generator. The electrosurgical system may be configured to deliver RF current and irrigation fluid until a threshold current level is detected, which is indicative of both a continuous flow of fluid at the electrode and purging completion. This in turn can cause the fluid delivery system and RF generator to deactivate. In certain embodiments, systems are provided having one or more sets of treatment electrodes and detection electrodes.


In certain embodiments, methods of purging (or priming) an electrosurgical system are provided. The methods may include the following steps: activating a high frequency power supply, (e.g., an RF output, RF source or RF generator), at a level that does not cause heating or damage to a patient or user in the event of unintended contact; activating a fluid delivery system for delivering conductive irrigation fluid to an electrode; monitoring current at an electrode, (e.g., between an active electrode and return electrode); detecting a threshold current level indicative of fluid at the electrode; and, causing the RF output and fluid delivery system to deactivate. In certain embodiments, methods of regulating an electrosurgical system to ensure that conductive fluid is continuously present at an electrode during a surgical procedure are provided.





BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS


FIG. 1 illustrates a variation of an electrosurgical system in accordance with at least some embodiments;



FIG. 2
a illustrates a variation of an electrosurgical system having detecting and treatment electrodes in accordance with at least some embodiments;



FIG. 2
b illustrates a magnified view of a handheld device of the electrosurgical system of FIG. 2a;



FIG. 3 illustrates a flow chart of a process for purging an electrosurgical system in accordance with at least some embodiments;



FIG. 4 illustrates a flow chart of another process for purging an electrosurgical system in accordance with at least some embodiments; and



FIG. 5 illustrates a flow chart of yet another process for purging an electrosurgical system in accordance with at least some embodiments.





DETAILED DESCRIPTION

Before the present invention is described in detail, it is to be understood that this invention is not limited to particular variations set forth herein as various changes or modifications may be made to the invention described and equivalents may be substituted without departing from the spirit and scope of the invention. As will be apparent to those of skill in the art upon reading this disclosure, each of the individual embodiments described and illustrated herein has discrete components and features which may be readily separated from or combined with the features of any of the other several embodiments without departing from the scope or spirit of the present invention. In addition, many modifications may be made to adapt a particular situation, material, composition of matter, process, process act(s) or step(s) to the objective(s), spirit or scope of the present invention. All such modifications are intended to be within the scope of the claims made herein.


Methods recited herein may be carried out in any order of the recited events which is logically possible, as well as the recited order of events. Furthermore, where a range of values is provided, it is understood that every intervening value, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. Also, it is contemplated that any optional feature of the inventive variations described may be set forth and claimed independently, or in combination with any one or more of the features described herein.


All existing subject matter mentioned herein (e.g., publications, patents, patent applications and hardware) is incorporated by reference herein in its entirety except insofar as the subject matter may conflict with that of the present invention (in which case what is present herein shall prevail). The referenced items are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such material by virtue of prior invention.


Reference to a singular item, includes the possibility that there are plural of the same items present. More specifically, as used herein and in the appended claims, the singular forms “a,” “an,” “said” and “the” include plural referents unless the context clearly dictates otherwise. It is further noted that the claims may be drafted to exclude any optional element. As such, this statement is intended to serve as antecedent basis for use of such exclusive terminology as “solely,” “only” and the like in connection with the recitation of claim elements, or use of a “negative” limitation. Last, it is to be appreciated that unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.


The treatment device of the present invention may have a variety of configurations as described above. However, one variation of the invention employs a treatment device using Coblation® technology.


As stated above, the assignee of the present invention developed Coblation® technology. Coblation® technology involves the application of a high frequency voltage difference between one or more active electrode(s) and one or more return electrode(s) to develop high electric field intensities in the vicinity of the target tissue. The high electric field intensities may be generated by applying a high frequency voltage that is sufficient to vaporize an electrically conductive fluid over at least a portion of the active electrode(s) in the region between the tip of the active electrode(s) and the target tissue. The electrically conductive fluid may be a liquid or gas, such as isotonic saline, blood, extracellular or intracellular fluid, delivered to, or already present at, the target site, or a viscous fluid, such as a gel, applied to the target site.


When the conductive fluid is heated enough such that atoms vaporize off the surface faster than they recondense, a gas is formed. When the gas is sufficiently heated such that the atoms collide with each other causing a release of electrons in the process, an ionized gas or plasma is formed (the so-called “fourth state of matter”). Generally speaking, plasmas may be formed by heating a gas and ionizing the gas by driving an electric current through it, or by shining radio waves into the gas. These methods of plasma formation give energy to free electrons in the plasma directly, and then electron-atom collisions liberate more electrons, and the process cascades until the desired degree of ionization is achieved. A more complete description of plasma can be found in Plasma Physics, by R. J. Goldston and P. H. Rutherford of the Plasma Physics Laboratory of Princeton University (1995), the complete disclosure of which is incorporated herein by reference.


As the density of the plasma or vapor layer becomes sufficiently low (i.e., less than approximately 1020 atoms/cm3 for aqueous solutions), the electron mean free path increases to enable subsequently injected electrons to cause impact ionization within the vapor layer. Once the ionic particles in the plasma layer have sufficient energy, they accelerate towards the target tissue. Energy evolved by the energetic electrons (e.g., 3.5 eV to 5 eV) can subsequently bombard a molecule and break its bonds, dissociating a molecule into free radicals, which then combine into final gaseous or liquid species. Often, the electrons carry the electrical current or absorb the radio waves and, therefore, are hotter than the ions. Thus, the electrons, which are carried away from the tissue towards the return electrode, carry most of the plasma's heat with them, allowing the ions to break apart the tissue molecules in a substantially non-thermal manner.


By means of this molecular dissociation (rather than thermal evaporation or carbonization), the target tissue structure is volumetrically removed through molecular disintegration of larger organic molecules into smaller molecules and/or atoms, such as hydrogen, oxygen, oxides of carbon, hydrocarbons and nitrogen compounds. This molecular disintegration completely removes the tissue structure, as opposed to dehydrating the tissue material by the removal of liquid within the cells of the tissue and extracellular fluids, as is typically the case with electrosurgical desiccation and vaporization. A more detailed description of this phenomena can be found in commonly assigned U.S. Pat. No. 5,697,882, the complete disclosure of which is incorporated herein by reference.


In some applications of the Coblation® technology, high frequency (RF) electrical energy is applied in an electrically conducting media environment to shrink or remove (i.e., resect, cut, or ablate) a tissue structure and to seal transected vessels within the region of the target tissue. Coblation® technology is also useful for sealing larger arterial vessels, e.g., on the order of about 1 mm in diameter. In such applications, a high frequency power supply is provided having an ablation mode, wherein a first voltage is applied to an active electrode sufficient to effect molecular dissociation or disintegration of the tissue, and a coagulation mode, wherein a second, lower voltage is applied to an active electrode (either the same or a different electrode) sufficient to heat, shrink, and/or achieve hemostasis of severed vessels within the tissue.


The amount of energy produced by the Coblation® device may be varied by adjusting a variety of factors, such as: the number of active electrodes; electrode size and spacing; electrode surface area; asperities and sharp edges on the electrode surfaces; electrode materials; applied voltage and power; current limiting means, such as inductors; electrical conductivity of the fluid in contact with the electrodes; density of the fluid; and other factors. Accordingly, these factors can be manipulated to control the energy level of the excited electrons. Since different tissue structures have different molecular bonds, the Coblation® device may be configured to produce energy sufficient to break the molecular bonds of certain tissue but insufficient to break the molecular bonds of other tissue. For example, fatty tissue (e.g., adipose) has double bonds that require an energy level substantially higher than 4 eV to 5 eV (typically on the order of about 8 eV) to break. Accordingly, the Coblation® technology generally does not ablate or remove such fatty tissue; however, it may be used to effectively ablate cells to release the inner fat content in a liquid form. Of course, factors may be changed such that these double bonds can also be broken in a similar fashion as the single bonds (e.g., increasing voltage or changing the electrode configuration to increase the current density at the electrode tips). A more complete description of this phenomena can be found in commonly assigned U.S. Pat. Nos. 6,355,032; 6,149,120 and 6,296,136, the complete disclosures of which are incorporated herein by reference.


The active electrode(s) of a Coblation® device may be supported within or by an inorganic insulating support positioned near the distal end of the instrument shaft. The return electrode may be located on the instrument shaft, on another instrument or on the external surface of the patient (i.e., a dispersive pad). The proximal end of the instrument(s) will include the appropriate electrical connections for coupling the return electrode(s) and the active electrode(s) to a high frequency power supply, such as an electrosurgical generator.


In one example of a Coblation® device for use with the present invention, the return electrode of the device is typically spaced proximally from the active electrode(s) a suitable distance to avoid electrical shorting between the active and return electrodes in the presence of electrically conductive fluid. In many cases, the distal edge of the exposed surface of the return electrode is spaced about 0.5 mm to 25 mm from the proximal edge of the exposed surface of the active electrode(s), preferably about 1.0 mm to 5.0 mm. Of course, this distance may vary with different voltage ranges, conductive fluids, and depending on the proximity of tissue structures to active and return electrodes. The return electrode will typically have an exposed length in the range of about 1 mm to 20 mm.


A Coblation® treatment device for use in the present invention may use a single active electrode or an array of active electrodes spaced around the distal surface of a catheter or probe. In the latter embodiment, the electrode array usually includes a plurality of independently current-limited and/or power-controlled active electrodes to apply electrical energy selectively to the target tissue while limiting the unwanted application of electrical energy to the surrounding tissue and environment resulting from power dissipation into surrounding electrically conductive fluids, such as blood, normal saline, and the like. The active electrodes may be independently current-limited by isolating the terminals from each other and connecting each terminal to a separate power source that is isolated from the other active electrodes. Alternatively, the active electrodes may be connected to each other at either the proximal or distal ends of the catheter to form a single wire that couples to a power source.


In one configuration, each individual active electrode in the electrode array is electrically insulated from all other active electrodes in the array within the instrument and is connected to a power source which is isolated from each of the other active electrodes in the array or to circuitry which limits or interrupts current flow to the active electrode when low resistivity material (e.g., blood, electrically conductive saline irrigant or electrically conductive gel) causes a lower impedance path between the return electrode and the individual active electrode. The isolated power sources for each individual active electrode may be separate power supply circuits having internal impedance characteristics which limit power to the associated active electrode when a low impedance return path is encountered. By way of example, the isolated power source may be a user selectable constant current source. In this embodiment, lower impedance paths will automatically result in lower resistive heating levels since the heating is proportional to the square of the operating current times the impedance. Alternatively, a single power source may be connected to each of the active electrodes through independently actuatable switches, or by independent current limiting elements, such as inductors, capacitors, resistors and/or combinations thereof. The current limiting elements may be provided in the instrument, connectors, cable, controller, or along the conductive path from the controller to the distal tip of the instrument. Alternatively, the resistance and/or capacitance may occur on the surface of the active electrode(s) due to oxide layers which form selected active electrodes (e.g., titanium or a resistive coating on the surface of metal, such as platinum).


The Coblation® device is not limited to electrically isolated active electrodes, or even to a plurality of active electrodes. For example, the array of active electrodes may be connected to a single lead that extends through the catheter shaft to a power source of high frequency current.


The voltage difference applied between the return electrode(s) and the active electrode(s) will be at high or radio frequency, typically between about 5 kHz and 20 MHz, usually being between about 30 kHz and 2.5 MHz, preferably being between about 50 kHz and 500 kHz, often less than 350 kHz, and often between about 100 kHz and 200 kHz. In some applications, applicant has found that a frequency of about 100 kHz is useful because the tissue impedance is much greater at this frequency. In other applications, such as procedures in or around the heart or head and neck, higher frequencies may be desirable (e.g., 400-600 kHz) to minimize low frequency current flow into the heart or the nerves of the head and neck.


The RMS (root mean square) voltage applied will usually be in the range from about 5 volts to 1000 volts, preferably being in the range from about 10 volts to 500 volts, often between about 150 volts to 400 volts depending on the active electrode size, the operating frequency and the operation mode of the particular procedure or desired effect on the tissue (i.e., contraction, coagulation, cutting or ablation.)


Typically, the peak-to-peak voltage for ablation or cutting with a square wave form will be in the range of 10 volts to 2000 volts and preferably in the range of 100 volts to 1800 volts and more preferably in the range of about 300 volts to 1500 volts, often in the range of about 300 volts to 800 volts peak to peak (again, depending on the electrode size, number of electrons, the operating frequency and the operation mode). Lower peak-to-peak voltages will be used for tissue coagulation, thermal heating of tissue, or collagen contraction and will typically be in the range from 50 to 1500, preferably 100 to 1000 and more preferably 120 to 400 volts peak-to-peak (again, these values are computed using a square wave form). Higher peak-to-peak voltages, e.g., greater than about 800 volts peak-to-peak, may be desirable for ablation of harder material, such as bone, depending on other factors, such as the electrode geometries and the composition of the conductive fluid.


As discussed above, the voltage is usually delivered in a series of voltage pulses or alternating current of time varying voltage amplitude with a sufficiently high frequency (e.g., on the order of 5 kHz to 20 MHz) such that the voltage is effectively applied continuously (as compared with, e.g., lasers claiming small depths of necrosis, which are generally pulsed about 10 Hz to 20 Hz). In addition, the duty cycle (i.e., cumulative time in any one-second interval that energy is applied) is on the order of about 50% for the present invention, as compared with pulsed lasers which typically have a duty cycle of about 0.0001%.


The preferred power source of the present invention delivers a high frequency current selectable to generate average power levels ranging from several milliwatts to tens of watts per electrode, depending on the volume of target tissue being treated, and/or the maximum allowed temperature selected for the instrument tip. The power source allows the user to select the voltage level according to the specific requirements of a particular neurosurgery procedure, cardiac surgery, arthroscopic surgery, dermatological procedure, ophthalmic procedures, open surgery or other endoscopic surgery procedure. For cardiac procedures and potentially for neurosurgery, the power source may have an additional filter, for filtering leakage voltages at frequencies below 100 kHz, particularly voltages around 60 kHz. Alternatively, a power source having a higher operating frequency, e.g., 300 kHz to 600 kHz may be used in certain procedures in which stray low frequency currents may be problematic. A description of one suitable power source can be found in commonly assigned U.S. Pat. Nos. 6,142,992 and 6,235,020, the complete disclosure of both patents are incorporated herein by reference for all purposes.


The power source may be current limited or otherwise controlled so that undesired heating of the target tissue or surrounding (non-target) tissue does not occur. In a presently preferred embodiment of the present invention, current limiting inductors are placed in series with each independent active electrode, where the inductance of the inductor is in the range of 10 uH to 50,000 uH, depending on the electrical properties of the target tissue, the desired tissue heating rate and the operating frequency. Alternatively, capacitor-inductor (LC) circuit structures may be employed, as described previously in U.S. Pat. No. 5,697,909, the complete disclosure of which is incorporated herein by reference. Additionally, current-limiting resistors may be selected. Preferably, these resistors will have a large positive temperature coefficient of resistance so that, as the current level begins to rise for any individual active electrode in contact with a low resistance medium (e.g., saline irrigant or blood), the resistance of the current limiting resistor increases significantly, thereby minimizing the power delivery from said active electrode into the low resistance medium (e.g., saline irrigant or blood).


Moreover, other treatment modalities (e.g., laser, chemical, other RF devices, etc.) may be used in the inventive method either in place of the Coblation® technology or in addition thereto.


In certain embodiments, electrosurgical systems and methods are provided having an improved conductive irrigation fluid purging operation which demonstrates increased efficiency such that the coordination of personnel in the sterile and non-sterile fields of an operating room is not required to purge the fluid delivery system or handheld device. The systems and methods allow for an automated purging sequence that does not need to be attended. In certain embodiments, electrosurgical systems and methods are provided which ensure that a fluid delivery system and/or handheld device of the electrosurgical system are completely or substantially purged on the first attempt to ensure that the electrosurgical system provides a safe and effective performance during surgery.


Turning now to an exemplary embodiment, FIG. 1 shows an electrosurgical system 10 which includes a high frequency power supply 12. Examples of high frequency power supplies or power sources may include but are not limited to an RF generator. (For exemplary purposes, in certain embodiments described herein the system will be described as utilizing an RF output or RF generator as the high frequency power supply or power source. As such, power supply 12 may also be referred to generally as a “generator” herein). The system may also include a fluid delivery system 14, a handheld device 16 having one or more electrodes 18 for delivering current, and one or more connectors 20a, 20b for coupling the handheld device to the fluid delivery system 14 and the RF generator 12. Power supply 12 has a selection means 26 to change the applied voltage level. Power supply 12 also includes means for energizing the electrodes 18 of device 16 through the depression of a first foot pedal 24 positioned close to the user and is connected to power supply 12 via connector 20d. A second foot pedal 25 may also be included for remotely adjusting the energy level applied to electrodes 18 or for selecting an alternate operating mode. Display 27 may be used to indicate the operating mode or representative voltage level delivered by power supply 12.


The electrosurgical system 10 may be configured to deliver RF current and conductive irrigation fluid until a threshold current level indicative of the presence of a continuous flow of fluid, which is indicative of a primed system and purging completion, is detected, thereby causing the fluid delivery system 14 and RF generator 12 to deactivate or delivery of fluid or RF current to a handheld device to stop or deactivate. The electrosurgical system may be configured such that delivery of RF current and/or conductive fluid are automatically started or activated when the handheld device is connected to the fluid delivery system and/or the RF generator.


The threshold current level can vary and depends on a variety of factors, e.g., the geometry of the device and the shape, and/or the size or number of electrodes utilized. Examples of threshold current levels include but are not limited to current levels greater than about 50 mA, or more specifically greater than about 70 mA. In certain embodiments, the threshold current level may range from about 10 to 60 mA or from about 60 to 150 mA. The system may optionally include a sensor for detecting current level. Various sensors known to persons of ordinary skill in the art for effectively detecting current may be utilized.


The fluid delivery system 14 may include a fluid control element 23 and a fluid source 22 for supplying a fluid, e.g., a conductive irrigation fluid. Fluid source 22 may be coupled to fluid control element 23 by connector 20c. The fluid control element 23 may be any suitable electromechanical device for controlling fluid delivery without making direct contact with the fluid. Examples of such devices include without limitation, a pinch type valve for pinching fluid delivery tubesets or a peristaltic pump for forcing fluid through a tubeset. Fluid control elements that make direct contact with the fluid to control fluid delivery are also contemplated.


The handheld device 16 may include a proximal end 17 and a distal end 19, having one or more electrodes 18 disposed near the distal end 19 of the device. As described above, the handheld device 16 may include one or more active electrodes and a return electrode. An electrode terminal including a single electrode or an array of electrodes may be provided. Optionally, the return electrode can be separate from the handheld device but within its vicinity, typically disposed proximally from the one or more active electrodes. Optionally, the handheld device is a bipolar RF handheld device.



FIG. 2
a shows another embodiment of an electrosurgical system 40. The system includes a fluid delivery system 44 and a handheld device 46 having a set of treatment electrodes 48 for conducting surgical treatment and a set of detecting electrodes 49 for monitoring fluid presence at an electrode (as shown in FIG. 2b). The system includes an RF generator 42 and one or more connectors 50a, 50b for connecting the handheld device 46 to the RF generator 42 and/or the fluid delivery system 44. The electrosurgical system 40 is configured to deliver RF current and fluid to or between the detecting electrodes until a threshold current indicative of purging completion of the fluid delivery system or handheld device is detected.


The RF generator 42 may include a relay 45 for switching RF current delivery from the detection electrodes 49 to the treatment electrodes 48, once a threshold current level is detected and purging is complete, thereby activating the set of treatment electrodes 48. Optionally, the relay switch 45 may switch RF current delivery from the treatment electrodes 48 back to the detection electrodes 49 when necessary. For example, in certain embodiments, the system may include a relay 45 for switching RF current delivery from the treatment electrodes 48 to the detection electrodes 49 when a reduced current level is detected in order to protect a patient from risks associated with inadequate fluid flow, which is often signaled by a reduction in detected current level. The system may be configured such that detection of a predetermined threshold current level indicative of the presence of a continuous flow of fluid and purging completion causes the RF generator 42 and fluid delivery system 44 to deactivate or triggers the relay switch 45 such that the treatment electrodes 48 are automatically activated and ready for surgery.


The set of detecting electrodes 49 may be positioned or oriented within a fluid pathway anywhere in the electrosurgical system or fluid delivery system, e.g., between the set of treatment electrodes 48, such that they are positioned to detect, through measurement of delivered current, the presence of fluid at an electrode or the continuous flow of fluid at an electrode to accurately identify purging completion.


It should be noted that certain components of the systems described above are functional in nature, and there illustration in such figures is not meant to limit the structure that performs these functions in any manner.



FIG. 3 shows an example of a flow chart or algorithm illustration illustrating one variation of a method of priming or purging an electrosurgical system 110 in accordance with at least some embodiments described herein. To initiate the purging sequence of the electrosurgical system, a primer switch may be activated (block 112) which may thereby set a purging timer and the fluid delivery speed. In certain embodiments, connecting the handheld device to the RF generator or output and fluid delivery system may automatically initiate the automated purging sequence, without the need to press or activate a primer switch. A control system for the electrosurgical system or the electrosurgical system itself may be activated and run through a series of checks. Examples of checks include but are not limited to: checking that the handheld device is connected to the RF source (block 114); checking that the handheld device is connected to the fluid delivery system; and checking that the fluid delivery system pump door is closed (block 116).


The fluid delivery system is then activated to deliver a conductive irrigation fluid to a handheld device or electrode (block 118). For example, the fluid delivery system may be activated at a predetermined speed for a predetermined amount of time sufficient to deliver fluid to the handheld device or electrode. The fluid delivery system may be run at a variety of speeds, for example, at pump speed (PSpeed) to deliver fluid to the handheld device quickly. Examples of fluid flow rates or speeds at which the fluid delivery system is operated include but are not limited to 60-90 ml/minute. In certain embodiments, the fluid delivery system may be activated to deliver fluid at pump speed or 77 ml/minute, for about one second.


The RF output is then activated at a level that does not cause heating or damage to the patient or user in the event of unintended contact. For example, the RF output voltage may be less than about 25 VRMS (block 120). The current level at the electrodes, for example, between active and return electrodes or at a detecting electrode (as described above), is monitored or measured (block 121) to detect a current level exceeding a threshold current level indicative of the presence of a continuous flow of fluid at the electrode, which is indicative of purging completion and removal of trapped air from the system. For example, in certain embodiments detection of a threshold current level of greater than about 50 mA is preferred as indicative of continuous fluid flow at the electrode (block 122). Upon detection of a current level exceeding a threshold indicative of the presence of a continuous flow of fluid at the electrode, the RF output is deactivated (block 124) and purging is complete (block 126).


If any of the above steps fail, the purging process or sequence may be repeated or continued until a threshold current level is detected and purging is complete.


For example, if during the purging sequence a threshold current level is not detected, the process may be repeated until such a threshold current level is detected and purging is complete. For example, if a threshold current level of greater than about 50 mA is not detected (block 122), the purging sequence may repeat, starting with the initial system checks as described above. The sequence may recheck the handheld device and fluid delivery system connections and/or the fluid delivery system or pump door status. The fluid delivery system and RF output may then be reactivated, as described above, and the current level monitored until a threshold current level is detected.


Also, the purging sequence may abort (block 128a) if the handheld device is found to be disconnected. The purging sequence may abort if the fluid delivery system is found to be disconnected. The purging sequence may abort (block 128b) if the fluid delivery system or pump door is found to be open.


Additionally, the system may check if a predetermined amount of time for completing purging is exceeded or elapsed (block 115). If so, the purging sequence may abort (block 128c) if a predetermined amount of time for completing purging is exceeded or elapsed. The predetermined amount of time for completing purging may vary. For example, such time may be from about 20 to 40 seconds or about 25 to 35 seconds or about 30 seconds.



FIG. 4 shows an example of a flow chart or algorithm illustration illustrating one variation of a method of purging an electrosurgical system 210 in accordance with at least some embodiments described herein. To initiate the purging sequence of the electrosurgical system, a primer switch may be activated (block 212). In certain embodiments, connecting the handheld device to the RF generator and fluid delivery system may automatically initiate the purging sequence, without the need to press or activate a primer switch. As a result, a control system for the electrosurgical system or the electrosurgical system itself may be activated and run through a series of checks. Examples of checks include but are not limited to: checking that the handheld device is connected to the RF source (block 214); checking that the handheld device is connected to the fluid delivery system; and checking that the fluid delivery system pump door is closed (block 216).


The fluid delivery system is then activated to deliver a conductive irrigation fluid to a handheld device or electrode (block 218). For example, the fluid delivery system may be activated at a predetermined speed for a predetermined amount of time sufficient to deliver fluid to the handheld device or electrode. The fluid delivery system may be run at a variety of speeds, for example, at pump speed (PSpeed) to deliver fluid to the handheld device quickly. Examples of fluid flow rates or speeds at which the fluid delivery system is operated include but are not limited to 60-90 ml/minute. In certain embodiments, the fluid delivery system may be activated to deliver fluid at pump speed or 77 ml/minute, for about one second.


The RF output is then activated at a level that does not cause heating or damage to the patient or user in the event of unintended contact. For example, the RF output voltage may be less than about 25 VRMS. Additionally, instead of delivering the RF voltage continuously the RF output may be pulsed such that RF voltage is delivered for a predetermined amount of time in a predetermined time interval. For example, the RF output voltage of approximately or less than about 25 VRMS may be delivered for about 50 ms every one second interval (block 242), thereby reducing the patient or user's exposure to RF energy. The current level at the electrodes, for example, between active and return electrodes or at a detecting electrode (as described above) is monitored or measured (block 221) to detect a current level exceeding a threshold current level indicative of the presence of a continuous flow of fluid at the electrode, which is indicative of purging completion and removal of trapped air from the system. For example, in certain embodiments detection of a threshold current level of greater than about 50 mA is preferred as indicative of continuous fluid flow at the electrode (block 222). Upon detection of a current level exceeding a threshold indicative of the presence of a continuous flow of fluid at the electrode, purging is complete (block 226). The RF output may be deactivated or remain activated to commence a surgical procedure.


If any of the above steps fail, the purging process or sequence may be repeated or continued until a threshold current level is detected and purging is complete.


For example, if during the purging sequence a threshold current level is not detected, the process may be repeated until such a threshold current level is detected and purging is complete. In certain embodiments in accordance with the present method, if a threshold current level of greater than about 50 mA is not detected, the RF output may be deactivated (block 244) and after a predetermined period of time, e.g., about one second, the purging sequence may repeat, starting with the initial system checks as described above. For example, the sequence may recheck the handheld device and fluid delivery system connections and/or the fluid delivery system or pump door status. The fluid delivery system and RF output may be reactivated, as described above, and the current level monitored until a threshold current level is detected.


Also, the purging sequence may abort (block 228a) if the handheld device is found to be disconnected. The purging sequence may abort if the fluid delivery system is found to be disconnected. The purging sequence may abort (block 228b) if the fluid delivery system or pump door is found to be open.


Additionally, the system may check if a predetermined amount of time for completing purging is exceeded or elapsed (block 215). If so, the purging sequence may abort (block 228c) if a predetermined amount of time for completing purging is exceeded or elapsed. The predetermined amount of time for completing purging may vary. For example, such time may be from about 20 to 40 seconds or about 25 to 35 seconds or about 30 seconds.



FIG. 5 shows an example of a flow chart or algorithm illustration illustrating yet another variation of a method of purging an electrosurgical system 310 in accordance with at least some embodiments described herein. To initiate the purging sequence of the electrosurgical system, a primer switch may be activated (block 312). In certain embodiments, connecting the handheld device to the RF generator and fluid delivery system may automatically initiate the purging sequence, without the need to press or activate a primer switch. As a result, a control system for the electrosurgical system or the electrosurgical system itself may be activated and run through a series of checks. Examples of checks include but are not limited to: checking that the handheld device is connected to the RF source (block 314); checking that the handheld device is connected to the fluid delivery system; and checking that the fluid delivery system pump door is closed (block 316).


The fluid delivery system is then activated to deliver a conductive irrigation fluid to a handheld device or electrode (block 318). For example, the fluid delivery system may be activated at a predetermined speed for a predetermined amount of time sufficient to deliver fluid to the handheld device or electrode. The fluid delivery system may be run at a variety of speeds, for example, at pump speed (PSpeed) to deliver fluid to the handheld device quickly. Examples of fluid flow rates or speeds at which the fluid delivery system is operated include but are not limited to 60-90 ml/minute. In certain embodiments, the fluid delivery system may be activated to deliver fluid at pump speed or 77 ml/minute, for about one second, which may result in a quick delivery of an initial dose of conductive fluid to the electrode.


The RF output is then activated at a level that does not cause heating or damage to the patient or user in the event of unintended contact. For example, the RF output voltage may be less than about 25 VRMS. The RF voltage may be delivered continuously or the RF output may be pulsed such that RF voltage is delivered for a predetermined amount of time in a predetermined time interval. For example, the RF output voltage of approximately or less than about 25 VRMS may be delivered for about 50 ms every one second interval (block 350), thereby reducing the patient or user's exposure to RF energy.


The current level between at the electrodes, for example, between active and return electrodes or at a detecting electrode (as described above), is monitored or measured (block 351) to detect a current level exceeding a first threshold current level indicative of the presence of fluid at the electrode. For example, in certain embodiments initial detection of a threshold current level of greater than about 50 mA is preferred as indicative of continuous fluid flow at the electrode (block 352). In certain embodiments, the RF may be pulsed such that it is delivered for about 50 ms every one second for a predetermined number of times, e.g., up to four times. As a result, four separate measurements of a threshold current level may be taken to accurately determine whether fluid is present at the electrode.


Upon detection of a current level exceeding a threshold indicative of the presence of a fluid at the electrode, the fluid flow speed or rate may be adjusted. For example, the fluid delivery system may be adjusted to run at a default or nominal surgical speed (block 353), i.e., the fluid flow rate may be reduced to run at the fluid flow rate typically used during surgical procedures (e.g., 13-55 ml/minute). The fluid delivery system may be activated to deliver fluid at the nominal surgical speed continuously or periodically until purging is complete.


The RF output is activated as described above, such that RF is delivered either continuously or periodically (i.e., pulsed). Whether the RF is pulsed such that it is delivered for about 50 ms every one second for a predetermined number of times or delivered continuously, the purging sequence may include performing a predetermined number of separate measurements of a threshold current level to accurately determine purging completion. This may be implemented to detect a threshold current level indicative of the initial presence of fluid at an electrode or the continuous flow of fluid at an electrode and purging completion. The current level between active and return electrodes is monitored and a related counter adjusted to detect and track a predetermined number of events where a current level exceeding a second threshold current level indicative of the presence of a continuous flow of fluid at the electrode, which is indicative of purging completion and removal of trapped air from the system.


For example, in certain embodiments it may be desirable to detect and keep track of the number of events where the current level exceeds a threshold value. By way of example, as shown in FIG. 5, three separate measurements detecting a threshold current level may be taken, in order to accurately determine the presence of a continuous flow of fluid at an electrode and purging completion, thereby ensuring that any air bubbles present in the tubing have been completely exhausted. Accordingly, in certain embodiments the system may run an initial check for current at the electrode, i.e., a threshold current level of greater than zero (block 354), prior to recording or detecting a threshold current level indicative of continuous fluid flow and purging completion. If no current is detected, the purging sequence may be repeated with the current level detection counter assigned a value of “1” or adjusting the detection counter value “plus one.”


The process is repeated and a current level is measured again, such that if the measured current level is greater than zero but less than the threshold current level (i.e., less than 70 mA) (block 355), the current level detection counter is assigned a value of “2” (or the detection counter value adjusted “plus one” from the previous value) and the process repeated again. It is preferred in certain embodiments that a threshold current level of greater than about 70 mA is detected to indicate continuous fluid flow at the electrode. Eventually, upon detection of a current level exceeding a threshold indicative of the presence of a continuous flow of fluid at the electrode, e.g., greater than 70 mA, the detection counter value is adjusted “plus one” from the previous value (block 356), whereby the detection counter is assigned a value of “3” (block 358) indicated at least three events where the current level exceeds the threshold value of 70 mA and signifying purging and pump priming is complete (block 360). The RF output may be deactivated or remain activated to commence a surgical procedure.


Again, if any of the above steps fail, the purging process or sequence may be repeated or continued until the desired predetermined threshold current level is detected and purging is complete. For example, if during the purging sequence a threshold current level is not detected, the process may be repeated until such a threshold current level is detected and purging is complete. More specifically, if a first threshold current level indicative of the presence of fluid at the electrode, e.g., a threshold current level of greater than about 50 mA, is not detected, the purging sequence may repeat, starting with the initial system checks as described above. The sequence may recheck the handheld device and fluid delivery system connections and/or the fluid delivery system or pump door status. The fluid delivery system and RF output may then be reactivated, as described above, and the current level monitored until a threshold current level is detected.


Also, if after slowing the pump to a default speed a threshold current level indicative of the presence of a continuous flow of fluid at the electrode, e.g., a threshold current level of greater than about 70 mA, is not detected, the purging sequence may repeat, starting with the initial system checks as described above. Additionally, in certain embodiments where multiple measurements may be desirable, if any of the separate measurements fails to detect the predetermined threshold current, e.g., whether it be the first, second or third detection or measurement sequence according to FIG. 5, the purging process or sequence may be repeated until the predetermined threshold current level is detected. The fluid delivery system and RF output may be reactivated as described above and the current level monitored until the predetermined threshold current levels are detected.


Also, as described above, the purging sequence may abort (block 328a) if the handheld device is found to be disconnected (block 314). The purging sequence may abort if the fluid delivery system is found to be disconnected. The purging sequence may abort (block 328b) if the fluid delivery system or pump door is found to be open (block 316).


Additionally, the system may check if a predetermined amount of time for completing purging is exceeded or elapsed (block 315). If so, the purging sequence may abort (block 328c) if a predetermined amount of time for completing purging is exceeded or elapsed. The predetermined amount of time for completing purging may vary as described above.


In certain embodiments, detecting a current level may include detecting an increase in delivered RF current indicative of conductive fluid present at an electrode, or indicative of the presence of a continuous flow of conductive fluid at the electrode, which is indicative of purging completion and removal of trapped air from the system.


In certain embodiments, the fluid delivery system may be continuously activated to provide a continuous conductive fluid flow during the purging sequence while a threshold current and thereby the presence of a continuous flow of conductive fluid is detected at an electrode for a predetermined period of time to ensure of purging completion and removal of trapped air from the system. The RF output may be continuously activated or periodically activated for a predetermined amount of time sufficient to make a reliable measurement of delivered RF current between the active and return electrodes, while the fluid delivery system is either continuously or periodically activated. Also, conductive fluid sources utilized during current detection and purging may vary. Examples of fluid sources include but are not limited to saline, blood, Ringer's lactate solution, etc.


In certain embodiments, the fluid flow rate may be reduced upon detecting an initial current level increase at the detection electrode(s). The reduced fluid flow rate may then be maintained to provide a robust monitoring of current to ensure of purging completion and the removal of trapped air. In related embodiments, the fluid delivery system may be continuously activated and the RF output may be periodically activated for a predetermined period of time to allow for a reliable measurement of a delivered RF current.


In another embodiment, a method of regulating an electrosurgical system to ensure that conductive fluid is continuously present at an electrode during a surgical procedure is provided. The method may include monitoring current delivered between an active electrode and return electrode on a handheld device connected to an RF generator and a fluid delivery system. The fluid flow rate of the conductive fluid present at an electrode is controlled or monitored and the fluid flow rate may be automatically adjusted in response to a detected change in delivered current level.


In certain embodiments, adjusting the fluid flow rate may include increasing the fluid flow rate in response to a decrease in delivered current level which is indicative of the presence of trapped air in the system. Optionally, the RF output or delivery of RF current may be deactivated if a threshold current level is not detected after adjusting the fluid flow rate, which is indicative of non-continuous fluid flow at the electrode. In certain embodiments, the method may include deactivating the RF output or delivery of RF current if a threshold fluid flow rate is not detected after adjusting the fluid flow rate, which is indicative of a non continuous fluid flow at the electrode. Still in other embodiments, adjusting the fluid flow rate may include decreasing the fluid flow rate in response to an increase in delivered current level.


Optionally, in the above embodiments, an alert may be generated to a user signaling deactivation of the high frequency power supply or of the RF output or delivery of RF current.


While the invention has been described in connection with the above described embodiments, it is not intended to limit the scope of the invention to the particular forms set forth, but on the contrary, it is intended to cover such alternatives, modifications, and equivalents as may be included within the scope of the invention. Further, the scope of the present invention fully encompasses other embodiments that may become obvious to those skilled in the art and the scope of the present invention is limited only by the appended claims.

Claims
  • 1. An electrosurgical system comprising: a high frequency power supply;a fluid delivery system;a handheld device comprising at least one electrode; andat least one connector for connecting the handheld device to the fluid delivery system and the high frequency power supply, wherein the electrosurgical system is configured to deliver a radiofrequency (RF) current and fluid until a threshold current level indicative of purging completion is detected causing the fluid delivery system and the high frequency power supply to deactivates;wherein the fluid delivery system comprises a fluid control element and a fluid source comprising an electrically conductive irrigation fluid, and wherein the fluid control element is an electromechanical device for controlling fluid delivery without making direct contact with the electrically conductive irrigation fluid.
  • 2. The electrosurgical system of claim 1, wherein the electrosurgical system is configured to detect the threshold current level indicative of a presence of the electrically conductive irrigation fluid at the at least one electrode.
  • 3. The electrosurgical system of claim 2, wherein the threshold current level is greater than about 50 mA.
  • 4. The electrosurgical system of claim 2, wherein the threshold current level is greater than about 70 mA.
  • 5. The electrosurgical cal system of claim 1, further comprising a sensor for detecting the threshold current level.
  • 6. The electrosurgical system of claim 5, wherein the sensor comprises a set of detecting electrodes.
  • 7. The electrosurgical system of claim 1, wherein the electrosurgical system is configured such that delivery of the RF current and the electrically conductive irrigation fluid automatically start once the handheld device is connected to the fluid delivery system and the high frequency power supply.
  • 8. The electrosurgical system of claim 1, wherein the electromechanical device comprises a pinch-type valve.
  • 9. The electrosurgical system of claim 1, wherein the electromechanical device comprises a peristaltic pump.
  • 10. The electrosurgical system of claim 1, wherein the handheld device has a proximal end and a distal end, and wherein the at least one electrode is disposed near the distal end.
  • 11. The electrosurgical system of claim 1, wherein the at least one electrode comprises an active electrode and a return electrode.
  • 12. The electrosurgical system of claim 1, wherein the high frequency power supply is an RF generator.
  • 13. The system of claim 1, further comprising a current level detection counter configured to track a predetermined number of events associated with detection of the threshold current level.
  • 14. An electrosurgical system comprising: a fluid delivery system;a handheld device comprising a set of treatment electrodes and a set of detecting electrodes;a radiofrequency (RF) generator; andat least one connector for connecting the handheld device to the RF generator and the fluid delivery system, wherein the electrosurgical system is configured to deliver current and fluid to the set of detecting electrodes until a threshold current level indicative of purging completion is detected.
  • 15. The electrosurgical system of claim 14, wherein the RF generator comprises a relay for switching RF delivery from the set of detecting electrodes to the set of treatment electrodes when the purging is complete, thereby activating the set of treatment electrodes.
  • 16. The electrosurgical system of claim 14, wherein the RF generator comprises a relay for switching RF delivery the set of treatment electrodes to the set of detecting electrodes when a reduced current level is detected to protect a patient from risks associated with inadequate fluid flow.
  • 17. The electrosurgical system of claim 14, wherein detection of the threshold current level indicative of the purging completion is configured to cause the RF generator and the fluid delivery system to deactivate.
  • 18. The electrosurgical system of claim 14, wherein the set of detecting electrodes are positioned within a fluid pathway to detect a current level indicative of a continuous flow of fluid and the purging completion.
  • 19. An electrosurgical system comprising: a high frequency power supply;a fluid delivery system;a handheld device comprising at least one electrode; andat least one connector for connecting the handheld device to the fluid delivery system and the high frequency power supply, wherein the electrosurgical system is configured to deliver a radiofrequency (RF) current and fluid until a threshold current level indicative of purging completion is detected causing the fluid delivery system and the high frequency power supply to deactivate;wherein the electrosurgical system is configured such that delivery of the RF current and the fluid automatically start once the handheld device is connected to the fluid delivery system and the high frequency power supply.
CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 12/633,916 filed Dec. 9, 2009, now U.S. Pat. No. 8,372,067 the complete disclosure of which is hereby incorporated by reference in its entirety for all purposes.

US Referenced Citations (547)
Number Name Date Kind
2050904 Trice Apr 1936 A
2056377 Wappler Oct 1939 A
2611365 Rubens Sep 1952 A
3434476 Shaw et al. Mar 1969 A
3633425 Sanford Jan 1972 A
3707149 Hao et al. Dec 1972 A
3718617 Royal Feb 1973 A
3815604 O'Malley et al. Jun 1974 A
3828780 Morrison, Jr. et al. Aug 1974 A
3901242 Storz Aug 1975 A
3920021 Hiltebrandt Nov 1975 A
3939839 Curtiss Feb 1976 A
3963030 Newton Jun 1976 A
3964487 Judson Jun 1976 A
3970088 Morrison Jul 1976 A
4033351 Hetzel Jul 1977 A
4040426 Morrison, Jr. Aug 1977 A
4043342 Morrison, Jr. Aug 1977 A
4074718 Morrison, Jr. Feb 1978 A
4092986 Schneiderman Jun 1978 A
D249549 Pike Sep 1978 S
4114623 Meinke et al. Sep 1978 A
4116198 Roos Sep 1978 A
4181131 Ogiu Jan 1980 A
4184492 Meinke et al. Jan 1980 A
4202337 Hren et al. May 1980 A
4228800 Degler, Jr. et al. Oct 1980 A
4232676 Herczog Nov 1980 A
4240441 Khalil Dec 1980 A
4248231 Herczog et al. Feb 1981 A
4301801 Schneiderman Nov 1981 A
4326529 Doss et al. Apr 1982 A
4346715 Gammell Aug 1982 A
4363324 Kusserow Dec 1982 A
4378801 Oosten Apr 1983 A
4381007 Doss Apr 1983 A
4418692 Guay Dec 1983 A
4474179 Koch Oct 1984 A
4476862 Pao Oct 1984 A
4509532 DeVries Apr 1985 A
4520818 Mickiewicz Jun 1985 A
4532924 Auth et al. Aug 1985 A
4548207 Reimels Oct 1985 A
4567890 Ohta et al. Feb 1986 A
4572206 Geddes et al. Feb 1986 A
4580557 Hertzmann Apr 1986 A
4587975 Salo et al. May 1986 A
4590934 Malis et al. May 1986 A
4593691 Lindstrom et al. Jun 1986 A
4658817 Hardy Apr 1987 A
4660571 Hess et al. Apr 1987 A
4674499 Pao Jun 1987 A
4682596 Bales et al. Jul 1987 A
4706667 Roos Nov 1987 A
4709698 Johnston et al. Dec 1987 A
4727874 Bowers et al. Mar 1988 A
4750902 Wuchinich et al. Jun 1988 A
4765331 Petruzzi et al. Aug 1988 A
4785823 Eggers et al. Nov 1988 A
4805616 Pao Feb 1989 A
4823791 D'Amelio et al. Apr 1989 A
4832048 Cohen May 1989 A
4846179 O'Connor Jul 1989 A
4860752 Turner Aug 1989 A
4898169 Norman et al. Feb 1990 A
4907589 Cosman Mar 1990 A
4920978 Colvin May 1990 A
4931047 Broadwin et al. Jun 1990 A
4936281 Stasz Jun 1990 A
4936301 Rexroth et al. Jun 1990 A
4943290 Rexroth et al. Jul 1990 A
4955377 Lennox et al. Sep 1990 A
4966597 Cosman Oct 1990 A
4967765 Turner et al. Nov 1990 A
4976711 Parins et al. Dec 1990 A
4979948 Geddes et al. Dec 1990 A
4998933 Eggers et al. Mar 1991 A
5007908 Rydell Apr 1991 A
5009656 Reimels Apr 1991 A
5026387 Thomas Jun 1991 A
5035696 Rydell Jul 1991 A
5047026 Rydell Sep 1991 A
5047027 Rydell Sep 1991 A
5057105 Malone et al. Oct 1991 A
5057106 Kasevich et al. Oct 1991 A
5078717 Parins et al. Jan 1992 A
5080660 Buelna Jan 1992 A
5083565 Parins Jan 1992 A
5084044 Quint Jan 1992 A
5085659 Rydell Feb 1992 A
5086401 Glassman et al. Feb 1992 A
5088997 Delahuerga et al. Feb 1992 A
5092339 Geddes et al. Mar 1992 A
5098431 Rydell Mar 1992 A
5099840 Goble Mar 1992 A
5102410 Dressel Apr 1992 A
5108391 Flachenecker et al. Apr 1992 A
RE33925 Bales et al. May 1992 E
5112330 Nishigaki et al. May 1992 A
5122138 Manwaring Jun 1992 A
5125928 Parins et al. Jun 1992 A
5156151 Imran Oct 1992 A
5167659 Ohtomo et al. Dec 1992 A
5171311 Rydell et al. Dec 1992 A
5174304 Latina et al. Dec 1992 A
5178620 Eggers et al. Jan 1993 A
5183338 Wickersheim et al. Feb 1993 A
5190517 Zieve et al. Mar 1993 A
5192280 Parins Mar 1993 A
5195959 Smith Mar 1993 A
5197466 Marchosky et al. Mar 1993 A
5197963 Parins Mar 1993 A
5207675 Canady May 1993 A
5217457 Delahuerga et al. Jun 1993 A
5217459 Kamerling Jun 1993 A
5249585 Turner et al. Oct 1993 A
5255980 Thomas et al. Oct 1993 A
5261410 Alfano et al. Nov 1993 A
5267994 Gentelia et al. Dec 1993 A
5267997 Farin et al. Dec 1993 A
5273524 Fox et al. Dec 1993 A
5277201 Stern Jan 1994 A
5281216 Klicek Jan 1994 A
5281218 Imran Jan 1994 A
5282799 Rydell Feb 1994 A
5290282 Casscells Mar 1994 A
5300069 Hunsberger et al. Apr 1994 A
5306238 Fleenor Apr 1994 A
5312400 Bales et al. May 1994 A
5314406 Arias et al. May 1994 A
5318563 Malis et al. Jun 1994 A
5324254 Phillips Jun 1994 A
5330470 Hagen Jul 1994 A
5334140 Phillips Aug 1994 A
5334183 Wuchinich Aug 1994 A
5334193 Nardella Aug 1994 A
5336172 Bales et al. Aug 1994 A
5336220 Ryan et al. Aug 1994 A
5336443 Odashima Aug 1994 A
5342357 Nardella Aug 1994 A
5348026 Davidson Sep 1994 A
5348554 Imran et al. Sep 1994 A
5354291 Bales et al. Oct 1994 A
5366443 Eggers et al. Nov 1994 A
5370675 Edwards et al. Dec 1994 A
5374261 Yoon Dec 1994 A
5375588 Yoon Dec 1994 A
5380277 Phillips Jan 1995 A
5380316 Aita et al. Jan 1995 A
5383874 Jackson et al. Jan 1995 A
5383876 Nardella Jan 1995 A
5383917 Desai et al. Jan 1995 A
5389096 Aita et al. Feb 1995 A
5395312 Desai Mar 1995 A
5400267 Denen et al. Mar 1995 A
5401272 Perkins Mar 1995 A
5403311 Abele et al. Apr 1995 A
5417687 Nardella et al. May 1995 A
5419767 Eggers et al. May 1995 A
5423810 Goble et al. Jun 1995 A
5423882 Jackman et al. Jun 1995 A
5436566 Thompson et al. Jul 1995 A
5437662 Nardella Aug 1995 A
5438302 Goble Aug 1995 A
5441499 Fritzsch Aug 1995 A
5449356 Walbrink et al. Sep 1995 A
5451224 Goble et al. Sep 1995 A
5454809 Janssen Oct 1995 A
5458596 Lax et al. Oct 1995 A
5458597 Edwards et al. Oct 1995 A
5472443 Cordis et al. Dec 1995 A
5472444 Huebner et al. Dec 1995 A
5486161 Lax et al. Jan 1996 A
5496312 Klicek Mar 1996 A
5496314 Eggers Mar 1996 A
5496317 Goble et al. Mar 1996 A
5505730 Edwards Apr 1996 A
5507743 Edwards et al. Apr 1996 A
5514130 Baker May 1996 A
5540683 Ichikawa et al. Jul 1996 A
5542915 Edwards et al. Aug 1996 A
5549598 O'Donnell, Jr. Aug 1996 A
5554152 Aita Sep 1996 A
5556397 Long et al. Sep 1996 A
5562703 Desai Oct 1996 A
5569242 Lax et al. Oct 1996 A
5571100 Goble et al. Nov 1996 A
5573533 Strul Nov 1996 A
5584872 LaFontaine et al. Dec 1996 A
5588960 Edwards et al. Dec 1996 A
5599350 Schulze et al. Feb 1997 A
5609151 Mulier et al. Mar 1997 A
5609573 Sandock Mar 1997 A
5633578 Eggers et al. May 1997 A
5634921 Hood et al. Jun 1997 A
5643304 Schechter et al. Jul 1997 A
5647869 Goble et al. Jul 1997 A
5658278 Imran et al. Aug 1997 A
5660567 Nierlich et al. Aug 1997 A
5662680 Desai Sep 1997 A
5676693 LaFontaine et al. Oct 1997 A
5681282 Eggers et al. Oct 1997 A
5683366 Eggers et al. Nov 1997 A
5697281 Eggers et al. Dec 1997 A
5697536 Eggers et al. Dec 1997 A
5697882 Eggers et al. Dec 1997 A
5697909 Eggers et al. Dec 1997 A
5697925 Taylor Dec 1997 A
5697927 Imran et al. Dec 1997 A
5700262 Acosta et al. Dec 1997 A
5715817 Stevens-Wright et al. Feb 1998 A
5722975 Edwards et al. Mar 1998 A
5725524 Mulier et al. Mar 1998 A
5749869 Lindenmeier et al. May 1998 A
5749871 Hood et al. May 1998 A
5749914 Janssen May 1998 A
5755753 Knowlton May 1998 A
5766153 Eggers et al. Jun 1998 A
5769847 Panescu et al. Jun 1998 A
5785705 Baker Jul 1998 A
5786578 Christy et al. Jul 1998 A
5800429 Edwards Sep 1998 A
5807395 Mulier et al. Sep 1998 A
5810764 Eggers et al. Sep 1998 A
5810802 Panescu et al. Sep 1998 A
5810809 Rydell Sep 1998 A
5836875 Webster, Jr. Nov 1998 A
5836897 Sakurai et al. Nov 1998 A
5843019 Eggers et al. Dec 1998 A
5860951 Eggers et al. Jan 1999 A
5860974 Abele Jan 1999 A
5860975 Goble et al. Jan 1999 A
5871469 Eggers et al. Feb 1999 A
5873855 Eggers et al. Feb 1999 A
5873877 McGaffigan et al. Feb 1999 A
5885277 Korth Mar 1999 A
5888198 Eggers et al. Mar 1999 A
5891095 Eggers et al. Apr 1999 A
5891134 Goble et al. Apr 1999 A
5897553 Mulier Apr 1999 A
5902272 Eggers et al. May 1999 A
5944715 Goble et al. Aug 1999 A
5954716 Sharkey et al. Sep 1999 A
5964786 Ochs et al. Oct 1999 A
6004319 Goble et al. Dec 1999 A
6013076 Goble et al. Jan 2000 A
6015406 Goble et al. Jan 2000 A
6024733 Eggers et al. Feb 2000 A
6027501 Goble et al. Feb 2000 A
6039734 Goble et al. Mar 2000 A
6047700 Eggers et al. Apr 2000 A
6056746 Goble et al. May 2000 A
6063079 Hovda et al. May 2000 A
6066134 Eggers et al. May 2000 A
6066489 Fields et al. May 2000 A
6068628 Fanton et al. May 2000 A
6074386 Goble et al. Jun 2000 A
6086585 Hovda et al. Jul 2000 A
6090106 Goble et al. Jul 2000 A
6090107 Borgmeier et al. Jul 2000 A
6093186 Goble et al. Jul 2000 A
6102046 Weinstein et al. Aug 2000 A
6103298 Edelson et al. Aug 2000 A
6105581 Eggers et al. Aug 2000 A
6109268 Thapliyal et al. Aug 2000 A
6117109 Eggers et al. Sep 2000 A
6126682 Sharkey et al. Oct 2000 A
6135999 Fanton et al. Oct 2000 A
6142992 Cheng et al. Nov 2000 A
6149620 Baker et al. Nov 2000 A
6156334 Meyer-Ingold et al. Dec 2000 A
6159194 Eggers et al. Dec 2000 A
6159208 Hovda et al. Dec 2000 A
6162217 Kannenberg et al. Dec 2000 A
6168593 Sharkey et al. Jan 2001 B1
6174309 Wrublewski et al. Jan 2001 B1
6179824 Eggers et al. Jan 2001 B1
6179836 Eggers et al. Jan 2001 B1
6183469 Thapliyal et al. Feb 2001 B1
6190381 Olsen et al. Feb 2001 B1
6197021 Panescu et al. Mar 2001 B1
6203542 Ellsberry et al. Mar 2001 B1
6210402 Olsen et al. Apr 2001 B1
6210405 Goble et al. Apr 2001 B1
6217574 Webster Apr 2001 B1
6224592 Eggers et al. May 2001 B1
6228078 Eggers May 2001 B1
6228081 Goble May 2001 B1
6234178 Goble et al. May 2001 B1
6235020 Cheng et al. May 2001 B1
6237604 Burnside et al. May 2001 B1
6238391 Olsen et al. May 2001 B1
6238393 Mulier et al. May 2001 B1
6241723 Heim et al. Jun 2001 B1
6249706 Sobota et al. Jun 2001 B1
6254600 Willink et al. Jul 2001 B1
6258087 Edwards et al. Jul 2001 B1
6261286 Goble et al. Jul 2001 B1
6261311 Sharkey et al. Jul 2001 B1
6264652 Eggers et al. Jul 2001 B1
6270460 McCartan et al. Aug 2001 B1
6277112 Underwood et al. Aug 2001 B1
6280441 Ryan Aug 2001 B1
6283961 Underwood et al. Sep 2001 B1
6293942 Goble et al. Sep 2001 B1
6296636 Cheng et al. Oct 2001 B1
6296638 Davison et al. Oct 2001 B1
6306134 Goble et al. Oct 2001 B1
6308089 von der Ruhr et al. Oct 2001 B1
6309387 Eggers et al. Oct 2001 B1
6312408 Eggers et al. Nov 2001 B1
6319007 Livaditis Nov 2001 B1
6322549 Eggers et al. Nov 2001 B1
6346104 Daly et al. Feb 2002 B2
6346107 Cucin Feb 2002 B1
6355032 Hovda et al. Mar 2002 B1
6363937 Hovda et al. Apr 2002 B1
6364877 Goble et al. Apr 2002 B1
6379350 Sharkey et al. Apr 2002 B1
6379351 Thapliyal et al. Apr 2002 B1
6391025 Weinstein et al. May 2002 B1
6409722 Hoey et al. Jun 2002 B1
6416507 Eggers et al. Jul 2002 B1
6416508 Eggers et al. Jul 2002 B1
6416509 Goble et al. Jul 2002 B1
6425912 Knowlton Jul 2002 B1
6432103 Ellsberry et al. Aug 2002 B1
6440129 Simpson Aug 2002 B1
6468274 Alleyne et al. Oct 2002 B1
6468275 Wampler et al. Oct 2002 B1
6482201 Olsen et al. Nov 2002 B1
6500173 Underwood et al. Dec 2002 B2
6514248 Eggers et al. Feb 2003 B1
6514250 Jahns et al. Feb 2003 B1
6517498 Burbank et al. Feb 2003 B1
6530922 Cosman Mar 2003 B2
6558382 Jahns et al. May 2003 B2
6565560 Goble et al. May 2003 B1
6578579 Burnside Jun 2003 B2
6589237 Woloszko et al. Jul 2003 B2
6602248 Sharps et al. Aug 2003 B1
6620156 Garito et al. Sep 2003 B1
6632193 Davison et al. Oct 2003 B1
6632220 Eggers et al. Oct 2003 B1
6635034 Cosmescu Oct 2003 B1
6640128 Vilsmeier et al. Oct 2003 B2
6656177 Truckai et al. Dec 2003 B2
6663554 Babaev Dec 2003 B2
6663627 Francischelli et al. Dec 2003 B2
6702810 McClurken et al. Mar 2004 B2
6730080 Harano et al. May 2004 B2
6746447 Davison et al. Jun 2004 B2
6749604 Eggers et al. Jun 2004 B1
6749608 Garito et al. Jun 2004 B2
D493530 Reschke Jul 2004 S
6770071 Woloszko et al. Aug 2004 B2
6780178 Palanker et al. Aug 2004 B2
6780180 Goble et al. Aug 2004 B1
6780184 Tanrisever Aug 2004 B2
6802842 Ellman et al. Oct 2004 B2
6805130 Tasto et al. Oct 2004 B2
6830558 Flaherty et al. Dec 2004 B2
6837887 Woloszko et al. Jan 2005 B2
6837888 Ciarrocca et al. Jan 2005 B2
6855143 Davison et al. Feb 2005 B2
6864686 Novak et al. Mar 2005 B2
6866671 Tierney et al. Mar 2005 B2
6872183 Sampson et al. Mar 2005 B2
6878149 Gatto Apr 2005 B2
6890307 Kokate et al. May 2005 B2
6892086 Russell May 2005 B2
6911027 Edwards et al. Jun 2005 B1
6920883 Bessette et al. Jul 2005 B2
6921398 Carmel et al. Jul 2005 B2
6929640 Underwood et al. Aug 2005 B1
6949096 Davison et al. Sep 2005 B2
6953461 McClurken et al. Oct 2005 B2
6960204 Eggers et al. Nov 2005 B2
6974453 Woloszko et al. Dec 2005 B2
6979328 Baerveldt et al. Dec 2005 B2
6979601 Marr et al. Dec 2005 B2
6984231 Goble et al. Jan 2006 B2
6986770 Hood Jan 2006 B2
6991631 Woloszko et al. Jan 2006 B2
7001382 Gallo Feb 2006 B2
7004941 Tvinnereim et al. Feb 2006 B2
7010353 Gan et al. Mar 2006 B2
7041102 Truckai et al. May 2006 B2
7070596 Woloszko et al. Jul 2006 B1
7090672 Underwood et al. Aug 2006 B2
7094215 Davison et al. Aug 2006 B2
7094231 Ellman et al. Aug 2006 B1
7104986 Hovda et al. Sep 2006 B2
7115139 McClurken et al. Oct 2006 B2
7131969 Hovda et al. Nov 2006 B1
7169143 Eggers et al. Jan 2007 B2
7179255 Lettice et al. Feb 2007 B2
7186234 Dahla et al. Mar 2007 B2
7192428 Eggers et al. Mar 2007 B2
7201750 Eggers et al. Apr 2007 B1
7217268 Eggers et al. May 2007 B2
7223265 Keppel May 2007 B2
7241293 Davison Jul 2007 B2
7247155 Hoey et al. Jul 2007 B2
7270658 Woloszko et al. Sep 2007 B2
7270659 Ricart et al. Sep 2007 B2
7270661 Dahla et al. Sep 2007 B2
7271363 Lee et al. Sep 2007 B2
7276061 Schaer et al. Oct 2007 B2
7276063 Davison et al. Oct 2007 B2
7278994 Goble Oct 2007 B2
7282048 Goble et al. Oct 2007 B2
7297143 Woloszko et al. Nov 2007 B2
7297145 Woloszko et al. Nov 2007 B2
7318823 Sharps et al. Jan 2008 B2
7331956 Hovda et al. Feb 2008 B2
7335199 Goble et al. Feb 2008 B2
RE40156 Sharps et al. Mar 2008 E
7344532 Goble et al. Mar 2008 B2
7357798 Sharps et al. Apr 2008 B2
7387625 Hovda et al. Jun 2008 B2
7419488 Ciarrocca et al. Sep 2008 B2
7429260 Underwood et al. Sep 2008 B2
7429262 Woloszko et al. Sep 2008 B2
7435247 Woloszko et al. Oct 2008 B2
7442191 Hovda et al. Oct 2008 B2
7445618 Eggers et al. Nov 2008 B2
7449021 Underwood et al. Nov 2008 B2
7462178 Woloszko et al. Dec 2008 B2
7468059 Eggers et al. Dec 2008 B2
7491200 Underwood et al. Feb 2009 B2
7507236 Eggers et al. Mar 2009 B2
7527624 Dubnack et al. May 2009 B2
7572251 Davison et al. Aug 2009 B1
7632267 Dahla Dec 2009 B2
7678069 Baker et al. Mar 2010 B1
7691101 Davison et al. Apr 2010 B2
7699830 Martin Apr 2010 B2
7704249 Woloszko et al. Apr 2010 B2
7708733 Sanders et al. May 2010 B2
7722601 Wham et al. May 2010 B2
7785322 Penny et al. Aug 2010 B2
7824398 Woloszko et al. Nov 2010 B2
7862560 Marion Jan 2011 B2
7879034 Woloszko et al. Feb 2011 B2
7887538 Bleich et al. Feb 2011 B2
7892230 Woloszko et al. Feb 2011 B2
7901403 Woloszko et al. Mar 2011 B2
7985072 Belikov et al. Jul 2011 B2
7988689 Woloszko et al. Aug 2011 B2
8012153 Woloszko et al. Sep 2011 B2
8114071 Woloszko et al. Feb 2012 B2
D658760 Cox et al. May 2012 S
8192424 Woloszko Jun 2012 B2
8257350 Marion Sep 2012 B2
8303583 Hosier et al. Nov 2012 B2
8568405 Cox et al. Oct 2013 B2
8574187 Marion Nov 2013 B2
8685018 Cox et al. Apr 2014 B2
8747399 Woloszko et al. Jun 2014 B2
8870866 Woloszko Oct 2014 B2
20020029036 Goble et al. Mar 2002 A1
20020042612 Hood et al. Apr 2002 A1
20020151882 Marko et al. Oct 2002 A1
20020183739 Long Dec 2002 A1
20030013986 Saadat Jan 2003 A1
20030014045 Russell Jan 2003 A1
20030014047 Woloszko et al. Jan 2003 A1
20030088245 Woloszko et al. May 2003 A1
20030158545 Hovda et al. Aug 2003 A1
20030167035 Flaherty et al. Sep 2003 A1
20030171743 Tasto et al. Sep 2003 A1
20030181903 Hood et al. Sep 2003 A1
20030208196 Stone Nov 2003 A1
20030212396 Eggers et al. Nov 2003 A1
20030216725 Woloszko et al. Nov 2003 A1
20030216726 Eggers et al. Nov 2003 A1
20030216732 Truckai et al. Nov 2003 A1
20030232048 Yang et al. Dec 2003 A1
20040030330 Brassell et al. Feb 2004 A1
20040058153 Ren et al. Mar 2004 A1
20040092925 Rizoiu et al. May 2004 A1
20040102044 Mao et al. May 2004 A1
20040116922 Hovda et al. Jun 2004 A1
20040127893 Hovda Jul 2004 A1
20040186418 Karashima Sep 2004 A1
20040230190 Dahla et al. Nov 2004 A1
20050004634 Ricart et al. Jan 2005 A1
20050010205 Hovda et al. Jan 2005 A1
20050033278 McClurken et al. Feb 2005 A1
20050197657 Goth et al. Sep 2005 A1
20050245923 Christopherson et al. Nov 2005 A1
20050261754 Woloszko et al. Nov 2005 A1
20050273091 Booth et al. Dec 2005 A1
20060036237 Davison et al. Feb 2006 A1
20060095031 Ormsby May 2006 A1
20060097615 Tsakalakos et al. May 2006 A1
20060161148 Behnke Jul 2006 A1
20060189971 Tasto et al. Aug 2006 A1
20060253117 Hovda et al. Nov 2006 A1
20060259025 Dahla Nov 2006 A1
20070106288 Woloszko et al. May 2007 A1
20070149966 Dahla et al. Jun 2007 A1
20070161981 Sanders et al. Jul 2007 A1
20070179495 Mitchell et al. Aug 2007 A1
20080004615 Woloszko et al. Jan 2008 A1
20080077128 Woloszko et al. Mar 2008 A1
20080138761 Pond Jun 2008 A1
20080140069 Filloux et al. Jun 2008 A1
20080154255 Panos et al. Jun 2008 A1
20080167645 Woloszko Jul 2008 A1
20080234674 McClurken et al. Sep 2008 A1
20080243116 Anderson Oct 2008 A1
20080261368 Ramin et al. Oct 2008 A1
20080300590 Horne et al. Dec 2008 A1
20090209956 Marion Aug 2009 A1
20090222001 Greeley et al. Sep 2009 A1
20100042101 Inagaki et al. Feb 2010 A1
20100121317 Lorang et al. May 2010 A1
20100152726 Cadouri et al. Jun 2010 A1
20100228246 Marion Sep 2010 A1
20100292689 Davison et al. Nov 2010 A1
20100318083 Davison et al. Dec 2010 A1
20100331883 Schmitz et al. Dec 2010 A1
20110137308 Woloszko et al. Jun 2011 A1
20110208177 Brannan Aug 2011 A1
20110245826 Woloszko et al. Oct 2011 A1
20110270256 Nelson et al. Nov 2011 A1
20110319887 Keppel Dec 2011 A1
20120083782 Stalder et al. Apr 2012 A1
20120095453 Cox et al. Apr 2012 A1
20120095454 Cox et al. Apr 2012 A1
20120109123 Woloszko et al. May 2012 A1
20120196251 Taft et al. Aug 2012 A1
20120197344 Taft et al. Aug 2012 A1
20120215221 Woloszko Aug 2012 A1
20120296328 Marion Nov 2012 A1
20140018798 Cox et al. Jan 2014 A1
20140025065 Marion Jan 2014 A1
20140135760 Cadouri et al. May 2014 A1
20140155882 Cox et al. Jun 2014 A1
20140236141 Woloszko et al. Aug 2014 A1
20140257277 Woloszko et al. Sep 2014 A1
20140257278 Woloszko et al. Sep 2014 A1
20140257279 Woloszko et al. Sep 2014 A1
20140276725 Cox Sep 2014 A1
20150032101 Woloszko et al. Jan 2015 A1
Foreign Referenced Citations (78)
Number Date Country
3119735 Jan 1983 DE
3930451 Mar 1991 DE
69635311 Apr 2007 DE
10201003288 Sep 2014 DE
423757 Mar 1996 EP
0703461 Mar 1996 EP
0740926 Nov 1996 EP
0754437 Jan 1997 EP
0694290 Nov 2000 EP
1334699 Aug 2003 EP
1428480 Jun 2004 EP
1707147 Oct 2006 EP
2055254 Feb 2015 EP
2313949 Jan 1977 FR
467502 Jun 1937 GB
2160102 Dec 1985 GB
2299216 Sep 1996 GB
2 308 979 Jul 1997 GB
2 308 980 Jul 1997 GB
2 308 981 Jul 1997 GB
2 327 350 Jan 1999 GB
2 327 351 Jan 1999 GB
2 327 352 Jan 1999 GB
2333455 Jul 1999 GB
2406793 Apr 2005 GB
2514442 Nov 2014 GB
57-57802 Apr 1982 JP
57-117843 Jul 1982 JP
9003152 Apr 1990 WO
9007303 Jul 1990 WO
9221278 Dec 1992 WO
9313816 Jul 1993 WO
9320747 Oct 1993 WO
9404220 Mar 1994 WO
9408654 Apr 1994 WO
9410921 May 1994 WO
9426228 Nov 1994 WO
9534259 Dec 1995 WO
9600040 Jan 1996 WO
9600042 Jan 1996 WO
9639086 Dec 1996 WO
9700646 Jan 1997 WO
9700647 Jan 1997 WO
9718768 May 1997 WO
9724073 Jul 1997 WO
9724074 Jul 1997 WO
9724993 Jul 1997 WO
9724994 Jul 1997 WO
9743971 Nov 1997 WO
9748345 Dec 1997 WO
9748346 Dec 1997 WO
9807468 Feb 1998 WO
9826724 Jun 1998 WO
9827879 Jul 1998 WO
9827880 Jul 1998 WO
9856324 Dec 1998 WO
9920213 Apr 1999 WO
9951155 Oct 1999 WO
9951158 Oct 1999 WO
9956648 Nov 1999 WO
0000098 Jan 2000 WO
0009053 Feb 2000 WO
0062685 Oct 2000 WO
0124720 Apr 2001 WO
0187154 May 2001 WO
0195819 Dec 2001 WO
0236028 May 2002 WO
02102255 Dec 2002 WO
03024305 Mar 2003 WO
03092477 Nov 2003 WO
2004026150 Apr 2004 WO
2004071278 Aug 2004 WO
2005125287 Dec 2005 WO
2007006000 Jan 2007 WO
2007056729 May 2007 WO
2010052717 May 2010 WO
2012050636 Apr 2012 WO
2012050637 Apr 2012 WO
Non-Patent Literature Citations (113)
Entry
Barry et al., “The Effect of Radiofrequency-generated Thermal Energy on the Mechanical and Histologic Characteristics of the Arterial Wall in Vivo: Implications of Radiofrequency Angioplasty” American Heart Journal vol. 117, pp. 332-341, 1982.
BiLAP Generator Settings, Jun. 1991.
BiLAP IFU 910026-001 Rev A for BiLAP Model 3525, J-Hook, 4 pgs, May 20, 1991.
BiLAP IFU 910033-002 Rev A for BiLAP Model 3527, L-Hook; BiLAP Model 3525, J-Hook; BiLAP Model 3529, High Angle, 2 pgs, Nov. 30, 1993.
Codman & Shurtleff, Inc. “The Malis Bipolar Coagulating and Bipolar Cutting System CMC-II” brochure, early, 2 pgs, 1991.
Codman & Shurtleff, Inc. “The Malis Bipolar Electrosurgical System CMC-III Instruction Manual” , 15 pgs, Jul. 1991.
Cook et al., “Therapeutic Medical Devices: Application and Design” , Prentice Hall, Inc., 3pgs, 1982.
Dennis et al. “Evolution of Electrofulguration in Control of Bleeding of Experimental Gastric Ulcers,” Digestive Diseases and Sciences, vol. 24, No. 11, 845-848, Nov. 1979.
Dobbie, A.K., “The Electrical Aspects of Surgical Diathermy, Bio Medical Engineering” Bio-Medical Engineering vol. 4, pp. 206-216, May 1969.
Elsasser, V.E. et al., “An Instrument for Transurethral Resection without Leakage of Current” Acta Medicotechnica vol. 24, No. 4, pp. 129-134, 1976.
Geddes, “Medical Device Accidents: With Illustrative Cases” CRC Press, 3 pgs, 1998.
Honig, W., “The Mechanism of Cutting in Electrosurgery” IEEE pp. 58-65, 1975.
Kramolowsky et al. “The Urological App of Electorsurgery” J. of Urology vol. 146, pp. 669-674, 1991.
Kramolowsky et al. “Use of 5F Bipolar Electrosurgical Probe in Endoscopic Urological Procedures” J. of Urology vol. 143, pp. 275-277, 1990.
Lee, B et al. “Thermal Compression and Molding of Artherosclerotic Vascular Tissue with Use” JACC vol. 13(5), pp. 1167-1171, 1989.
Letter from Department of Health to Jerry Malis dated Jan. 24, 1991, 3 pgs.
Letter from Department of Health to Jerry Malis dated Jul. 25, 1985, 1 pg.
Letter from Jerry Malis to FDA dated Jul. 25, 1985, 2 pgs.
Lu, et al., “Electrical Thermal Angioplasty: Catheter Design Features, in Vitro Tissue Ablation Studies and In Vitro Experimental Findings,” Am J. Cardiol vol. 60, pp. 1117-1122, Nov. 1, 1987.
Malis, L., “Electrosurgery, Technical Note,” J. Neursurg., vol. 85, pp. 970-975, Nov. 1996.
Malis, L., “Excerpted from a seminar by Leonard I. Malis, M.D. at the 1995 American Association of Neurological Surgeons Meeting,” 1pg, 1995.
Malis, L., “Instrumentation for Microvascular Neurosurgery” Cerebrovascular Surgery, vol. 1, pp. 245-260, 1985.
Malis, L., “New Trends in Microsurgery and Applied Technology,” Advanced Technology in Neurosurgery, pp. 1-16, 1988.
Malis, L., “The Value of Irrigation During Bipolar Coagulation” See ARTC 21602, 1 pg, Apr. 9, 1993.
Nardella, P.C., SPIE 1068: pp. 42-49, Radio Frequency Energy and Impedance Feedback, 1989.
O'Malley, Schaum's Outline of Theory and Problems of Basic Circuit Analysis, McGraw-Hill, 2nd Ed., pp. 3-5, 1992.
Olsen MD, Bipolar Laparoscopic Cholecstectomy Lecture (marked confidential), 12 pgs, Oct. 7, 1991.
Pearce, John A. “Electrosurgery”, pgs. 17, 69-75, 87, John Wiley & Sons, New York, 1986.
Pearce, John A., “Electrosurgery”, Handbook of Biomedical Engineering, chapter 3, Academic Press Inc., N.Y., pp. 98-113, 1988.
Piercey et al., “Electrosurgical Treatment of Experimental Bleeding Canine Gastric Ulcers” Gastroenterology vol. 74(3), pp. 527-534, 1978.
Protell et al., “Computer-Assisted Electrocoagulation: Bipolar v. Monopolar in the Treatment of Experimental Canine Gastric Ulcer Bleeding,” Gastroenterology vol. 80, No. 3, pp. 451-455, 1981.
Ramsey et al., “A Comparison of Bipolar and Monopolar Diathermy Probes in Experimental Animals”, Urological Research vol. 13, pp. 99-102, 1985.
Selikowitz et al., “Electric Current and Voltage Recordings on the Myocardium During Electrosurgical Procedures in Canines,” Surgery, Gynecology & Obstetrics, vol. 164, pp. 219-224, Mar. 1987.
Shuman, “Bipolar Versus Monopolar Electrosurgery: Clinical Applications,” Dentistry Today, vol. 20, No. 12, 7 pgs, Dec. 2001.
Slager et al. “Spark Erosion of Arteriosclerotic Plaques” Z. Kardiol. 76:Suppl. 6, pp. 67-71, 1987.
Slager et al. “Vaporization of Atherosclerotice Plaques by Spark Erosion” JACC 5(6): pp. 1382-1386, Jun. 1985.
Stoffels, E. et al., “Investigation on the Interaction Plasma-Bone Tissue”, E-MRS Spring Meeting, 1 pg, Jun. 18-21, 2002.
Stoffels, E. et al., “Biomedical Applications of Plasmas”, Tutorial presented prior to the 55th Gaseous Electronics Conference in Minneapolis, MN, 41 pgs, Oct. 14, 2002.
Stoffels, E. et al., “Plasma Interactions with Living Cells”, Eindhoven University of Technology, 1 pg, 2002.
Stoffels, E. et al., “Superficial Treatment of Mammalian Cells using Plasma Needle”, J. Phys. D: Appl. Phys. 26, pp. 2908-2913, Nov. 19, 2003.
Stoffels, E. et al., “Plasma Needle”, Eindhoven University of Technology, 1 pg, Nov. 28, 2003.
Stoffels, E. et al., “Plasma Physicists Move into Medicine”, Physicsweb, 1 pg, Nov. 2003.
Stoffels, E. et al., “Plasma Treated Tissue Engineered Skin to Study Skin Damage”, Biomechanics and Tissue Engineering, Materials Technology, 1 pg, 2003.
Stoffels, E. et al., “Plasma Treatment of Dental Cavities: A Feasibility Study”, IEEE Transaction on Plasma Science, vol. 32, No. 4, pp. 1540-1542, Aug. 2004.
Stoffels, E. et al., “The Effects of UV Irradiation and Gas Plasma Treatment on Living Mammalian Cells and Bacteria: A Comparative Approach”, IEEE Transaction on Plasma Science, vol. 32, No. 4, pp. 1544-1550, Aug. 2004.
Stoffels, E. et al., “Electrical and Optical Characterization of the Plasma Needle”, New Journal of Physics 6, pp. 1-14, Oct. 28, 2004.
Stoffels, E. et al., “Where Plasma Meets Plasma”, Eindhoven University of Technology, 23 pgs, 2004.
Stoffels, E. et al., “Gas Plasma effects on Living Cells”, Physica Scripta, T107, pp. 79-82, 2004.
Stoffels, E. et al., “Plasma Treatment of Mammalian Vascular Cells: A Quantitative Description”, IEEE Transaction on Plasma Science, vol. 33, No. 2, pp. 771-775, Apr. 2005.
Stoffels, E. et al., “Deactivation of Escherichia Coli by the Plasma Needle”, J. Phys. D: Appl. Phys. 38, pp. 1716-1721, May 20, 2005.
Stoffels, E. et al., “Development of a Gas Plasma Catheter for Gas Plasma Surgery”, XXVIIth ICPIG, Endoven University of Technology, pp. 18-22, Jul. 2005.
Stoffels, E. et al., “Development of a Smart Positioning Sensor for the Plasma Needle”, Plasma Sources Sci. Technol. 15, pp. 582-589, Jun. 27, 2006.
Stoffels, E. et al., Killing of S. Mutans Bacteria Using a Plasma Needle at Atmospheric Pressure, IEEE Transaction on Plasma Science, vol. 34, No. 4, pp. 1317-1324, Aug. 2006.
Stoffels, E. et al., “Plasma-Needle Treatment of Substrates with Respect to Wettability and Growth of Excherichia Coli and Streptococcus Mutans”, IEEE Transaction on Plasma Science, vol. 34, No. 4, pp. 1325-1330, Aug. 2006.
Stoffels, E. et al., “Reattachment and Apoptosis after Plasma-Needle Treatment of Cultured Cells”, IEEE Transaction on Plasma Science, vol. 34, No. 4, pp. 1331-1336, Aug. 2006.
Stoffels, E. et al., “UV Excimer Lamp Irradiation of Fibroblasts: The Influence on Antioxidant Homostasis”, IEEE Transaction on Plasma Science, vol. 34, No. 4, pp. 1359-1364, Aug. 2006.
Stoffels, E. et al., “Plasma Needle for In Vivo Medical Treatment: Recent Developments and Perspectives”, Plasma Sources Sci. Technol. 15, pp. S169-S180, Oct. 6, 2006.
Swain, C.P., et al., “Which Electrode, A Comparison of four endoscopic methods of electrocoagulation in experimental bleeding ulcers” Gut vol. 25, pp. 1424-1431, 1987.
Tucker, R. et al., Abstract P14-11, p. 248, “A Bipolar Electrosurgical Turp Loop” , Nov. 1989.
Tucker, R. et al. “A Comparison of Urologic Application of Bipolar Versus Monopolar Five French Electrosurgical Probes” J. of Urology vol. 141, pp. 662-665, 1989.
Tucker, R. et al. “In vivo effect of 5 French Bipolar and Monopolar Electrosurgical Probes on the Porcine Bladder” Urological Research vol. 18, pp. 291-294, 1990.
Tucker, R. et al., “Demodulated Low Frequency Currents from Electrosurgical Procedures,” Surgery, Gynecology and Obstetrics, 159:39-43, 1984.
Tucker et al. “The interaction between electrosurgical generators, endoscopic electrodes, and tissue,” Gastrointestinal Endoscopy, vol. 38, No. 2, pp. 118-122, 1992.
Valley Forge Scientific Corp., “Summary of Safety and Effective Information from 510K”, 2pgs, 1991.
Valley Forge's New Products, CLINICA, 475, 5, Nov. 6, 1991.
Valleylab SSE2L Instruction Manual, 11 pgs, Jan. 6, 1983.
Valleylab, Inc. “Valleylab Part No. 945 100 102 A” Surgistat Service Manual, pp. 1-46, Jul. 1988.
Wattiez, Arnaud et al., “Electrosurgery in Operative Endoscopy,” Electrosurgical Effects, Blackwell Science, pp. 85-93, 1995.
Wyeth, “Electrosurgical Unit” pp. 1181-1202, 2000.
Buchelt, et al. “Excimer Laser Ablation of Fibrocartilage: An In Vitro and In Vivo Study”, Lasers in Surgery and Medicine, vol. 11, pp. 271-279, 1991.
Costello et al., “Nd: YAG Laser Ablation of the Prostate as a Treatment for Benign Prostatic Hypertrophy”, Lasers in Surgery and Medicine, vol. 12, pp. 121-124, 1992.
Rand et al., “Effect of Elecctrocautery on Fresh Human Articular Cartilage”, J. Arthro. Surg., vol. 1, pp. 242-246, 1985.
European Examination Report for EP 02773432 4 pgs, Sep. 22, 2009.
European Examination Report for EP 05024974 4 pgs, Dec. 5, 2008.
European Examination Report (1st) for EP 04708664 7pgs, Sep. 7, 2009.
European Examination Report for EP 02749601.7 4pgs, Dec. 2, 2009.
European Examination Report (2nd) for EP 04708664 5pgs, May 3, 2010.
European Examination Report (3rd) for EP 04708664 6pgs, Nov. 6, 2012.
European Search Report for EP 02773432 3pgs, Dec. 19, 2008.
European Search Report for EP 04708664.0 5pgs, Apr. 6, 2009.
European Search Report for EP 98953859, 2 pgs. Jul. 2, 2001.
Suppl European Search Report for EP 98953859, 3 pgs, Oct. 18, 2001.
Extended European Search Report for EP09152846, 8pgs, Jan. 5, 2010.
European Search Report for EP 99945039.8, 3 pgs, Oct. 1, 2001.
European Search Report for EP 09152850, 2 pgs, Dec. 29, 2009.
PCT International Preliminary Examination Report for PCT/US02/19261, 3 pgs, Mar. 25, 2003.
PCT International Search Report for PCT/US02/19261, 1 pg, Mailed Sep. 18, 2002.
PCT International Search Report for PCT/US02/29476, 1 pg, Mailed May 24, 2004.
PCT International Search Report for PCT/US03/13686, 1 pg, Mailed Nov. 25, 2003.
PCT International Search Report for PCT/US04/03614, 1 pg, Mailed Sep. 14, 2004.
PCT International Search Report for PCT/US98/22323, 1 pg, Mailed Mar. 3, 1999.
PCT International Search Report for PCT/US99/14685, 1 pg, Mailed Oct. 21, 1999.
PCT International Search Report for PCT/US99/18289, 1 pg, Mailed Dec. 7, 1999.
PCT Notification of International Preliminary Examination Report for PCT/US98/22323, 5 pgs, Mailed Nov. 28, 2000.
PCT Notification of International Preliminary Examination Report for PCT/US99/14685, 4 pgs, Mailed Feb. 20, 2001.
PCT Notification of International Preliminary Examination Report for PCT/US99/18289, 4 pgs, Mailed Aug. 7, 2000.
PCT Notification of International Search Report and Written Opinion for PCT/US06/26321, 8pgs, Mailed Apr. 25, 2007.
PCT Notification of the International Search Report and Written Opinion for PCT/US06/60618, 7pgs, Mailed Oct. 5, 2007.
PCT Notification of the International Search Report and Written Opinion for PCT/US07/69856, 7pgs, Mailed Jun. 5, 2008.
PCT Written Opinion of the International Searching Authority for PCT/US04/03614, 4 pgs, Mailed Sep. 14, 2004.
PCT Notification of the International Search Report and Written Opinion for PCT/US2011/033784 11 pgs, Mailed Aug. 18, 2011.
PCT Notification of the International Search Report and Written Opinion for PCT/US2011/033761 11 pgs, Mailed Jul. 22, 2011.
UK Search Report for GB0800129.9 2pgs, May 8, 2008.
UK Search Report for GB0805062.7 1 pg, Jul. 16, 2008.
UK Search Report for GB0900604.0 4 pgs, May 15, 2009.
UK Search Report for GB1110342.1 3pgs, Oct. 18, 2011.
UK Suppl Search Report for GB1110342.1 2pgs, Aug. 16, 2012.
Slager et al., “Electrical nerve and Muscle Stimulation by Radio Frequency Surgery: Role of Direct Current Loops Around the Active Electrode”, IEEE Transactions on Biomedical engineering, vol. 40, No. 2, pp. 182-187, Feb. 1993.
UK Combined Search and Exam Report for GB1403997.8 5pgs, Sep. 17, 2014.
Elgrabli, D., Abella-Gallart, S., Aguerre-Chariol, O., Robidel F.R., Boczkowski, J., Lacroix, G. (2007). Effect of BSA on carbon nanotube dispersion in vivi and in vitro studies. vol. 1, No. 4, pp. 266-278., 2007.
Keffer, E.W., Botterman, B.B., Romero, M.I., Rossi, A.F. Fross, G.W. (2008). Carbon nanotube coating improves neronal recordings. vol. 3, pp. 434-439, 2008.
“Work functions for photoelectric effect”. (2001). Retrieved on Jun. 11, 2014 from http://hyperphysics.phyastr.gsu.edu/hbase/tables/photoelec.html., 2001.
Wikipedia Field Electron Emission. Retrieved on Dec. 29, 2014 from http://en.wikipedia.org/wiki/Field—electron—emission, Dec. 29, 2014.
Related Publications (1)
Number Date Country
20130116680 A1 May 2013 US
Divisions (1)
Number Date Country
Parent 12633916 Dec 2009 US
Child 13724179 US