US 6,702,810 B2Grant

Fluid delivery system and controller for electrosurgical devices

Issue Date:2004-03-09

•30 Claims

•11 Drawing Sheets

Abstract

The invention provides a system for treating tissue that includes a power measurement device, a flow rate controller coupled to the power measurement device, and an electrosurgical device configured and arranged to provide radio frequency power and conductive fluid to the tissue, wherein the flow rate controller is configured and arranged to modify a flow rate of the conductive fluid to the tissue, based on signals from the power measurement device. The invention also provides methods and devices for modifying flow rate of conductive fluid to tissue based on measurement of radio frequency power delivered to the tissue.

Metadata

Assignee

Tissuelink Medical Inc.

Inventors

Michael E. McClurken
Robert Luzzi

Application Information

Application Number:US 09/797,049

Filing Date:2001-03-01

Priority Date:2000-03-06

Art Unit:7

Classifications

IPC:

A61B 1818

Patent Drawings (11 sheets)

Description

[0002] This application claims the benefit of priority of U.S. Application Serial No. 60/187,114, filed Mar. 6, 2000, the entire disclosure of which is incorporated herein by reference.

Field of the Invention

[0003] This invention relates to the field of devices for use in operative surgery upon tissues of the body. More particularly, the invention relates to electrosurgical methods and systems for treatment of body tissues.

Background of the Invention

[0004] Electrosurgical devices use electrical energy, most commonly radio frequency (RF) energy, to cut tissue or to cauterize blood vessels. During use, a voltage gradient is created at the tip of the device, thereby inducing current flow and related heat generation in the tissue. With sufficiently high levels of electrical energy, the heat generated is sufficient to cut the tissue and, advantageously, to stop the bleeding from severed blood vessels.

[0005] Current electrosurgical devices can cause the temperature of tissue being treated to rise significantly higher than 100° C., resulting in tissue desiccation, tissue sticking to the electrodes, tissue perforation, char formation and smoke generation. Peak tissue temperatures as a result of RF treatment of target tissue can be as high as 320° C., and such high temperatures can be transmitted to adjacent tissue via thermal diffusion. Undesirable results of such transmission to adjacent tissue include unintended thermal damage to the tissue.

[0006] Using saline to couple RF electrical energy to tissue prevents such undesirable effects as sticking, desiccation, smoke production and char formation. One key factor is preventing tissue desiccation, which occurs if tissue temperature exceeds 100° C. and all of the intracellular water boils away, leaving the tissue extremely dry and much less electrically conductive. However, an uncontrolled flow rate of saline can provide too much cooling at the electrode/tissue interface. This cooling reduces the temperature of the target tissue being treated, and the rate at which tissue thermal coagulation occurs is determined by tissue temperature. This, in turn, can result in longer treatment time, to achieve the desired tissue temperature for cauterization or cutting of the tissue. Long treatment times are undesirable for surgeons since it is in the best interest of the patient, physician and hospital to perform surgical procedures as quickly as possible.

[0007] RF energy delivered to tissue is unpredictable and often not optimal when using general-purpose generators. Most general-purpose RF generators have modes for different waveforms (cut, coagulation, or a blend of these two) and device types (monopolar, bipolar), as well as power levels that can be set in watts. However, once these settings are chosen, the actual power delivered to tissue can vary dramatically over time as tissue impedance changes over the course of RF treatment. This is because the power delivered by most generators is a function of tissue impedance, with the power ramping down as impedance either decreases toward zero or increases significantly to several thousand ohms.

[0008] A further limitation of current electrosurgical devices arises from size constraints of the device in comparison to tissue that is encountered during a single surgical procedure. During the course of a single procedure, for example, a surgeon often encounters a wide variety of tissue sizes. Surgical devices often come in a variety of sizes because larger segments of tissue physically require commensurately larger electrode jaws or tips, but smaller segments of tissue often are not optimally treated by the much larger size RF device. It is undesirable to require numerous surgical devices during a single procedure, because this wastes valuable operating room time, can make it difficult to precisely relocate the treatment site, increases the risk of infection, and increases the cost by increasing the number of different surgical devices that are needed to complete the surgical procedure.

[0009] For example, a bipolar saline-enhanced tissue sealing forceps that has jaws long enough to effectively seal a 30 mm length of tissue may not be desirable for sealing a segment of tissue that is 10 mm in length. Excess saline from one of the electrode jaws (for a bipolar device) can flow to the other electrode in the space where there is no intervening tissue. This flow of electrically conductive saline can act as an electrical resistor in parallel with the electrical pathway through the target tissue. Electrical current flow through the saline can divert or shunt RF energy away from going through the target tissue, and slow down the rate at which the target tissue is heated and treated.

[0010] A surgeon may first be sealing and cutting lung tissue as part of a wedge resection using the full 30 mm jaw length 2-3 times to remove a tip of a lobe of lung for biopsy. If the intraoperative histopathology indicates that the suspected tissue has a malignant tumor, then the surgeon may convert the procedure to a lobectomy. As part of the lobectomy the surgeon will want to seal and cut large blood vessels that supply the lobe. Alternatively, the surgeon may want to toughen up or coagulate large vessels with RF and then apply a ligating clip to assure hemostasis before cutting. Even compressed, these blood vessels might only fill a small fraction of the 30 mm length of electrode jaw. For at least the reasons identified above, this is an undesirable situation with current electrosurgical devices.

Summary of the Invention

[0011] The invention provides a system for treating tissue comprising a power measurement device, a flow rate controller coupled to the power measurement device, and an electrosurgical device configured and arranged to provide radio frequency power and conductive fluid to the tissue, wherein the flow rate controller is configured and arranged to modify a flow rate of the conductive fluid to the tissue, based on signals from the power measurement device.

[0012] Preferably, the flow rate controller modifies the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. In a preferred embodiment, the flow rate controller modifies the flow rate of the conductive fluid to the tissue using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0013] In another embodiment, the invention provides a device for modifying flow rate of conductive fluid to tissue based on measurement of radio frequency power delivered to the tissue, the device comprising a flow rate controller configured and arranged to modify flow rate of the conductive fluid to the tissue, based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. Preferably, the device modifies the flow rate of the conductive fluid to the tissue using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0014] In an alternative embodiment, the invention provides a device for treating tissue using radio frequency power and conductive fluid, the device comprising a sensing device, and a processor coupled to the sensing device, wherein the processor is configured and arranged to adjust flow rate of the conductive fluid to the tissue, by determining a level of radio frequency power applied to the tissue using the sensing device, and adjusting the flow rate of the conductive fluid to the tissue. Preferably, the processor is configured and arranged to adjust the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. Preferably, the flow rate controller modifies the flow rate of the conductive fluid to the tissue using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0015] In another embodiment, the invention provides a method for treating tissue comprising applying radio frequency power and conductive fluid to the tissue using a surgical device, wherein the conductive fluid is provided to the tissue at a fluid flow rate, determining an amount of radio frequency power applied to the tissue, and modifying the fluid flow rate based on the power applied to the tissue. Preferably, the step of modifying the fluid flow rate based on the power applied to the tissue comprises modifying the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. Preferably, the step of modifying the fluid flow rate based on the power applied to the tissue comprises determining the fluid flow rate using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0016] In an alternative embodiment, the invention provides a method for treating tissue comprising providing a surgical device comprising an electrode, wherein the surgical device is configured and arranged to receive radio frequency power and conductive fluid and deliver the radio frequency power and conductive fluid to the tissue, determining the radio frequency power applied to the tissue, and providing the conductive fluid to the tissue at a fluid flow rate, wherein the fluid flow rate is modified to control boiling of the conductive fluid at the tissue. Preferably, the step of providing the conductive fluid to the tissue at a fluid flow rate comprises providing the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. In a preferred embodiment, the step of providing the conductive fluid to the tissue at a fluid flow rate comprises providing the conductive fluid to the tissue using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0017] In another embodiment, the invention provides a system for treating tissue comprising a power measurement device, a flow rate controller coupled to the power measurement device, a flow control device coupled to the flow rate controller, and an electrosurgical device coupled to the flow control device and the power measurement device, wherein the electrosurgical device is configured and arranged to provide radio frequency power and conductive fluid to the tissue, and wherein the flow rate controller is configured and arranged to modify a flow rate of the conductive fluid to the electrosurgical device, based on signals from the power measurement device. Preferably, the flow control device comprises a pump. In one embodiment, the pump comprises a peristaltic pump. In another embodiment, the pump comprises a syringe pump. Preferably, the electrosurgical device comprises a bipolar electrosurgical device.

[0018] According to this embodiment, the flow rate controller is preferably configured and arranged to modify the flow rate of the conductive fluid to the flow control device based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor. In a preferred embodiment, the flow rate controller is configured and arranged to modify the flow rate of the conductive fluid to the tissue using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

[0019] The invention can improve the speed of tissue coagulation provided by fluid-enhanced electrosurgery by assuring that the electrode-tissue interface is within a desired temperature range (for example, not significantly hotter than 100° C.) through the control of the fraction of conductive fluid that is boiled off at the electrode-tissue interface. This improvement can be achieved by measuring power provided to the device and regulating the flow of fluid to the device. Preferably, tissue sensors (for example, that would measure tissue temperature or tissue impedance) are not required according to the invention.

[0020] Some embodiments of the invention can provide one or more advantages, such as the ability to achieve the desired tissue effect (for example, coagulation, cutting, or the like) in a fast, effective manner. The invention can also provide the ability to treat tissue quickly without using a tissue sensor (for example, a temperature sensor) built into the device or a custom special-purpose generator. The invention can allow a surgeon to use a variety of electrosurgical devices with a wide variety of general-purpose generators. Further, the invention can provide the ability to use an electrosurgical device that is capable of quickly and effectively sealing a wide variety of tissue sizes and thicknesses.

Brief Description of the Drawings

[0021] FIG. 1 is a block diagram showing one embodiment of the overall control system of the invention, and an electrosurgical device.

[0022] FIG. 2 is a schematic graph that describes the relationship between RF power to tissue (P), flow rate of saline (Q), and tissue temperature (T).

[0023] FIG. 3 is schematic graph that describes the relationship between RF power to tissue (P), flow rate of saline (Q), and tissue temperature (T) when heat conduction to adjacent tissue is neglected.

[0024] FIG. 4 is a graph showing the relationship of percentage saline boiling and saline flow rate (cc/min) for an exemplary RF generator output of 75 watts.

[0025] FIG. 5 is a schematic graph that describes the relationship of load impedance (Z, in ohms) and generator output power (P, in watts), for an exemplary generator output of 75 watts in a bipolar mode.

[0026] FIG. 6 is a schematic graph that describes the relationship of time (t, in seconds) and tissue impedance (Z, in ohms) after RF activation.

[0027] FIG. 7 is a schematic side view of one embodiment of a bipolar electrosurgical device.

[0028] FIG. 8 is a schematic close-up section side view of the tip of the device shown in FIG. 7.

[0029] FIG. 9 is a schematic top view of the bipolar electrosurgical device shown in FIG. 7.

[0030] FIG. 10 is a schematic close-up section top view of the tip of the device shown in FIG. 9.

[0031] FIG. 11 is a schematic close-up section side view of the electrodes of the device shown in FIG. 9 showing saline shunting without boiling of the saline.

[0032] FIG. 11ais a diagram that describes the equivalent electrical circuit for tissue in parallel with a single saline shunt.

[0033] FIG. 11bis a graph that describes the relationship of ratio of saline to tissue resistance (R_s/R_t) and percent power shunted into saline.

[0034] FIG. 12 is a schematic close-up side section view of the electrodes of the device shown in FIG. 9 showing a large percentage of the saline boiling at the tissue treatment site.

[0035] FIG. 13 is a schematic close-up side section view of electrodes of the device shown in FIG. 9 showing two gutters slid out to direct saline flow distally toward tissue.

[0036] FIG. 14 is a schematic close-up cross-section view along line A—A of FIG. 9, showing the two gutters positioned to collect and direct saline flow distally.

[0037] FIG. 15 is a schematic close-up cross-section view of one embodiment of the jaws of the device shown in FIG. 9, wherein the jaws include a tissue-activated valve.

[0038] FIG. 16 is a schematic close-up side section view of one embodiment of the jaws of the device shown in FIG. 9, wherein the jaws include tissue-activated valves to direct flow distally.

Detailed Description of the Preferred Embodiments

[0039] Overview

[0040] The invention provides a system, device and methods that preferably improve control of tissue temperature at a treatment site during a medical procedure. The invention is particularly useful during surgical procedures upon tissues of the body, where tissue is often cut and coagulated. The invention involves the use of electrosurgical procedures, which utilize RF power and conductive fluid to treat tissue. Preferably, a desired tissue temperature range is achieved through adjusting parameters, such as conductive fluid flow rate, that affect the temperature at the tissue/electrode interface. Preferably, the device achieves a desired tissue temperature utilizing a desired percentage boiling of the conductive solution at the tissue/electrode interface. In a preferred embodiment, the invention provides a control device, the device comprising a flow rate controller that receives a signal indicating power applied to the system, and adjusts the flow rate of conductive fluid from a fluid source to an electrosurgical device. The invention also contemplates a control system comprising a flow rate controller, a measurement device that measures power applied to the system, and a pump that provides fluid at a desired flow rate.

[0041] The invention will be discussed generally with reference to FIG. 1. FIG. 1 shows a block diagram of one embodiment of a system of the invention. As shown in FIG. 1, conductive fluid is provided from a fluid source 1, through a fluid line 2, to a pump 3, which has an outlet fluid line 4 that is connected to an electrosurgical device 5. In a preferred embodiment, the conductive fluid comprises saline, such as sterile, normal saline. Although the description herein will describe saline as a conductive fluid, one of skill in the art would understand, upon reading this disclosure, that other conductive fluids can be used in accordance with the invention. The conductive fluid can comprise physiologic saline (“normal” saline, or 0.9% NaCl solution), lactated Ringer's™, or the like.

[0042] A generator 6 provides RF energy via a cable 7 to a power measurement device 8 that measures the RF electrical power. In this embodiment, the power measurement device 8 does not turn the power off or on or alter the power in any way. A power switch 15 connected to the generator 6 is provided by the generator manufacturer and is used to turn the generator 6 on and off. The power switch 15 can comprise any switch to turn the power on and off, and is commonly provided in the form of a footswitch or other easily operated switch. A cable 9 carries RF energy from the power measurement device 8 to the electrosurgical device 5. Power is preferably measured before it reaches the electrosurgical device.

[0043] A flow rate controller 11 includes a selection switch 12 that can be set to achieve desired levels of percentage fluid boiling (for example, 100%, 98%, 80% boiling). The flow rate controller 11 receives a signal 10 from the power measurement device 8 and calculates the correct fluid flow rate based on percentage boiling indicated by the selection switch 12. In a preferred embodiment, a fluid switch 13 is provided so that the fluid system can be primed (air eliminated) before turning the generator 6 on. The output signal 16 of the flow rate controller 11 is sent to the pump 3 motor to regulate the flow rate of conductive fluid, and thereby provide an appropriate fluid flow rate for the amount of power being delivered.

[0044] Throughout the present description, like reference numerals and letters indicate corresponding structure throughout the several views, and such corresponding structure need not be separately discussed.

[0045] In one embodiment, the invention comprises a flow rate controller that is configured and arranged to be connected to a source of RF power, and a source of conductive fluid. The device of the invention receives information about the level of RF power applied to an electrosurgical device, and adjusts the flow rate of the conductive fluid to the electrosurgical device, thereby controlling temperature at the tissue treatment site.

[0046] In another embodiment, elements of the system are physically included together in one electronic enclosure. One such embodiment is shown by enclosure within the outline box 14 of FIG. 1. In the illustrated embodiment, the pump 3, flow rate controller 11, and power measurement device 8 are enclosed within an enclosure, and these elements are connected through electrical connections to allow signal 10 to pass from the power measurement device 8 to the flow rate controller 11, and signal 16 to pass from the flow rate controller 11 to the pump 3. Other elements of a system can also be included within one enclosure, depending upon such factors as the desired application of the system, and the requirements of the user.

[0047] The pump 3 can be any suitable pump used in surgical procedures to provide saline or other fluid at a desired flow rate. Preferably, the pump 3 comprises a peristaltic pump. Alternatively, pump 3 can be a “syringe pump,” with a built-in fluid supply; or a double-acting syringe pump with two syringes such that they can draw saline from a reservoir. Conductive fluid can also be provided from an intravenous (“I.V.”) bag full of saline that flows under the influence of gravity to the pump 3. Similar pumps can be used in connection with the invention, and the illustrated embodiments are exemplary only. The precise configuration of the pump 3 is not critical to the invention. In some embodiments, the pump can be substituted with any type of flow controller, to allow the user to control the flow rate of conductive fluid to the device. Alternatively, a valve configuration can be substituted for pump 3.

[0048] The components of the system will now be described in detail.

[0049] The Flow Rate Controller

[0050] The flow rate controller 11 controls the rate of flow from the fluid source 1, based upon the amount of RF power provided from the generator 6 to the electrosurgical device 5. The flow rate of conductive fluid, such as saline, interacts with the RF power and various modes of heat transfer away from the target tissue, as described herein.

[0051] FIG. 2 shows a schematic graph that describes the relationship between the flow rate of saline, RF power to tissue, and regimes of boiling. Based on a simple one-dimensional lumped parameter model of the heat transfer, the peak tissue temperature can be estimated, and once tissue temperature is estimated, it follows directly whether it is hot enough to boil saline.

[0052] P=ΔT/R+ρc_ρQ₁ΔT+ρQ_bh_v (1)

[0053] Where P=the total RF electrical power that is converted into heat.

[0054] Conduction.

[0055] The first term [ΔT/R] in equation (1) is heat conducted to adjacent tissue, represented as 70 in FIG. 2, where:

[0056] ΔT=(T−T_∞) the difference in temperature between the peak tissue temperature (T) and the normal temperature (T_∞) of the body tissue (° C.). Normal temperature of the body tissue is generally 37° C.; and

[0057] R=Thermal Resistance of surrounding tissue, the ratio of the temperature difference to the heat flow (° C./watt).

[0058] This thermal resistance can be estimated from published data gathered in experiments on human tissue (Phipps, J. H., “Thermometry studies with bipolar diathermy during hysterectomy,” Gynaecological Endoscopy,3:5-7 (1994)). As described by Phipps, Kleppinger bipolar forceps were used with an RF power of 50 watts, and the peak tissue temperature reached 320° C. For example, using the energy balance of equation (1), and assuming all the RF heat put into tissue is conducted away, then R can be estimated:

[0059] R=ΔT/P=(320−37)/50=5.7≈6° C./watt

[0060] However, it is undesirable to allow the tissue temperature to reach 320° C., since tissue will become desiccated. At a temperature of 320° C., the fluid contained in the tissue is typically boiled away, resulting in the undesirable tissue effects described herein. Rather, it is preferred to keep the peak tissue temperature at no more than 100° C. to prevent desiccation of the tissue. Assuming that saline boils at 100° C., the first term in equation (1) (ΔT/R) is equal to (100−37)/6=10.5 watts. Thus, based on this example, the maximum amount of heat conducted to adjacent tissue without any significant risk of tissue desiccation is 10.5 watts.

[0061] Referring to FIG. 2, RF power to tissue is represented on the X-axis as P (watts) and flow rate of saline (cc/min) is represented on the Y-axis as Q. When the flow rate of saline equals zero (Q=0), there is an “offset” RF power that shifts the origin of the sloped lines 76, 78, and 80 to the right. This offset is the heat conducted to adjacent tissue. For example, using the calculation above for bipolar forceps, this offset RF power is about 10.5 watts. If the power is increased above this level with no saline flow, the peak tissue temperature can rise well above 100° C., resulting in tissue desiccation from the boiling off of water in the cells of the tissue.

[0062] Convection.

[0063] The second term [ρc_ρQ₁ΔT] in equation (1) is heat used to warm up the flow of saline without boiling the saline, represented as 72 in FIG. 2, where:

[0064] ρ=Density of the saline fluid that gets hot but does not boil (approximately 1.0 gm/cm³);

[0065] c_ρ=Specific heat of the saline (approximately 4.1 watt-sec/gm-° C.);

[0066] Q₁=Flow rate of the saline that is heated (cm³/sec); and

[0067] ΔT=Temperature rise of the saline. Assuming that the saline is heated to body temperature before it gets to the electrode, and that the peak saline temperature is similar to the peak tissue temperature, this is the same ΔT as for the conduction calculation above.

[0068] The onset of boiling can be predicted using equation (1) with the last term on the right set to zero (no boiling) (ρQ_bh_v=0), and solving equation (1) for Q₁leads to:

[0069] Q₁=[P−ΔT/R]/ρc_ρΔT (2)

[0070] This equation defines the line shown in FIG. 2 as the line of onset of boiling 76. It is possible in some embodiments that the flow of conductive fluid can be nonuniformly heated, thereby reducing the term in the denominator of Equation (2), ρc_ρΔT. If the amount of convection is less due to nonuniformity of heating, conductive fluid boiling would occur sooner. In other words, the slope of the curve will be steeper at a given power, and conductive fluid will boil at a lower flow rate. This type of nonuniformity can be associated with device configurations and hence could be used to provide a level of control of convection. For example, for a particular type of device known to provide nonuniform heating of the conductive solution, the invention can provide an “offset” to take this into account to provide the desired level of boiling at the electrode/tissue interface.

[0071] Boiling.

[0072] The third term [ρQ_bh_v] in equation (1) relates to heat that goes into converting liquid saline to vapor saline and is represented as 74 in FIG. 2, where:

[0073] Q_b=Flow rate of saline that boils (cm³/sec); and

[0074] h_v=Heat of vaporization of saline (approximately 2,000 watt-sec/gm).

[0075] A flow rate of only 1 cc/min will absorb a significant amount of heat if it is completely boiled, or about ρQ_bh_v=(1)({fraction (1/60)})(2,000)=33.3 watts. The heat needed to warm this flow rate from body temperature to 100° C. is much less, or ρc_ρQ₁ΔT=(1)(4.1)({fraction (1/60)})(100−37)=4.3 watts. In other words, the most significant factor contributing to heat transfer from a wet electrode device can be fractional boiling. The present invention recognizes this fact and exploits it.

[0076] Fractional boiling can be described by equation (3) below:

\begin{matrix} Q_{1} = \frac{{P - Δ T / R}}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}} & (3) \end{matrix}

[0077] If the ratio of Q_b/Q₁is 0.50 this is the 50% boiling line 78 shown in FIG. 2. If the ratio is 1.0 this is the 100% boiling line 80 shown in FIG. 2.

[0078] Control Strategy

[0079] Since the amount of heat conducted away to adjacent tissue is difficult to precisely predict, it is preferable, from a control point of view, to assume the worst case situation of zero heat conduction, and provide enough saline so that if necessary, all the RF power could be used to heat up and boil the saline, thus providing that the peak tissue temperature will not go over 100° C. a significant amount. This situation is shown in the schematic graph of FIG. 3.

[0080] It is desirable to control the saline flow rate so that it is always on a “line of constant % boiling” for consistent tissue effect. If the device is monopolar and shunting through saline is not an issue, then it can be preferable to operate close to, but not over the line of the onset of boiling, 76ain FIG. 3. This preferably keeps tissue as hot as possible with causing desiccation. Alternatively, if the device is bipolar and shunting of electrical energy through excess saline is an issue, then it can be preferable to operate along a line of constant boiling such as line 78ain FIG. 3, the 50% line. This simple proportional control will have the flow rate determined by equation (4), where K is the proportionality constant:

[0081] Q₁=K×P (4)

[0082] In essence, when power P goes up, the flow rate Q will be proportionately increased. Conversely, when power P goes down, the flow rate Q will be proportionately decreased.

[0083] K is primarily dependent on the fraction of saline that boils, as shown in equation (5), which is equation (3) solved for K after eliminating P using equation (4), and neglecting the conduction term (ΔT/R):

\begin{matrix} K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}} & (5) \end{matrix}

[0084] Thus, the present invention provides a method of controlling boiling of conductive fluid at the tissue/electrode interface. In a preferred embodiment, this provides a method of treating tissue without use of tissue sensors, such as temperature or impedance sensors. Preferably, the invention can control boiling of conductive fluid at the tissue/electrode interface and thereby control tissue temperature without the use of feedback loops.

[0085] FIG. 4 shows an exemplary graph of flow rate versus % boiling for a situation where the RF power is 75 watts. The percent boiling is represented on the X-axis, and the saline flow rate (cc/min) is represented on the Y-axis. According to this example, at 100% boiling the most desirable saline flow rate is 2 cc/min.

[0086] As discussed herein, RF energy delivery to tissue can be unpredictable and vary with time, even though the generator has been “set” to a fixed wattage.

[0087] The schematic graph of FIG. 5 shows the general trends of the output curve of a typical general-purpose generator, with the output power changing as load (tissue plus cables) impedance changes. Load impedance (in ohms) is represented on the X-axis, and generator output power (in watts) is represented on the Y-axis. In the illustrated embodiment, the electrosurgical power (RF) is set to 75 watts in a bipolar mode. As shown in the figure, the power will remain constant as it was set as long as the impedance stays between two cut-offs of impedance, that is, between 50 ohms and 300 ohms in the illustrated embodiment. Below load impedance of 50 ohms, the power will decrease, as shown by the low impedance ramp 48. Above load impedance of 300 ohms, the power will decrease, as shown by the high impedance ramp 46. Of particular interest to saline-enhanced electrosurgery is the low impedance cut-off (low impedance ramp 48), where power starts to ramp down as impedance drops further.

[0088] FIG. 6 shows the general trend of how tissue impedance generally changes with time for saline-enhanced electrosurgery. As tissue heats up, the temperature coefficient of the tissue and saline in the cells is such that the tissue impedance decreases. Thus, as tissue heats up, the load impedance decreases, approaching the impedance cut-off of 50 ohms. Once tissue is sufficiently heated, such that the impedance cut-off is passed, the power decreases along the lines of the low impedance ramp 48 of FIG. 5.

[0089] Combining the effects shown in FIG. 5 and FIG. 6, it becomes clear that when using a general-purpose generator set to a “fixed” power, the actual power delivered can change dramatically over time as tissue heats up and impedance drops. Looking at FIG. 5, if the impedance drops from 100 to 75 ohms over time, the power output would not change because the curve is “flat” in that region of impedances. If, however, the impedance drops from 75 to 30 ohms one would “turn the corner” onto the low impedance ramp 48 portion of the curve and the power output would decrease dramatically.

[0090] According to the invention, the control device receives a signal indicating the drop in actual power delivered to the tissue and adjusts the flow rate of saline to maintain the tissue/electrode interface at a desired temperature. In a preferred embodiment, the drop in actual power delivered is sensed by the power measurement device 8 (shown in FIG. 1), and the flow rate of saline is decreased by the flow rate controller 11 (also shown in FIG. 1). Preferably, this reduction in saline flow rate allows the tissue temperature to stay as hot as possible without desiccation. If the control device was not in operation and the flow rate allowed to remain higher, the tissue would be over-cooled at the lower power input. This would result in decreasing the temperature of the tissue at the treatment site.

[0091] The flow rate controller 11 of FIG. 1 can be a simple “hard-wired” analog or digital device that requires no programming by the user or the manufacturer. The flow rate controller 11 can alternatively include a processor, with or without a storage medium, in which the determination procedure is performed by software, hardware, or a combination thereof. In another embodiment, the flow rate controller 11 can include semi-programmable hardware configured, for example, using a hardware descriptive language, such as Verilog. In another embodiment, the flow rate controller 11 of FIG. 1 is a computer, microprocessor-driven controller with software embedded. In yet another embodiment, the flow rate controller 11 can include additional features, such as a mechanism to automatically keep the saline flow on for several seconds after the RF is turned off to provide a post-coagulation cooling of the tissue or “quench,” which can increase the strength of the tissue seal.

[0092] As discussed herein, the saline can act as a shunt and divert energy away from target tissue. This is a phenomenon that can only occur with a bipolar device. In a monopolar device, saline can “pool” in the treatment area, and can, in some situations, divert energy by pooling. For the present discussion, shunting in connection with a bipolar device will be discussed.

[0093] In order to describe the underlying issue of saline shunting, an exemplary bipolar endoscopic electrosurgical device will be described in some detail. The bipolar electrosurgical device is described for purposes of illustrating the invention only, and it is understood that a wide variety of electrosurgical devices can be used in connection with the invention.

[0094] Preferably, the control device of the invention is used in connection with an electrosurgical device that is capable of controlling saline flow (for example, by controlling the location from which the saline is released from the electrosurgical device to the tissue). Any electrosurgical device that is capable of controlling saline flow is preferably used in connection with the invention described herein.

[0095] FIG. 7 shows an overall simple side schematic view of one embodiment of an electrosurgical device 5athat is designed to grasp, coagulate and then cut tissue. The electrosurgical device 5aincludes a shaft 17, two opposing jaws 18 at the distal tip of the shaft 17, a collar 19 for rotating the entire shaft, a proximal handle 20, an actuation lever 21 which when squeezed will close the opposing jaws 18, a pair of paddles 22 to activate the built-in cutting mechanism (not shown in the figure), and a cable 23 attached to the handle that contains two electrical wires and one fluid channel (not shown individually in the figure). In use, tissue to be treated is positioned between the jaws 18 of the device 5a. The actuation lever 21 is then moved in direction of arrow 26, thereby drawing the opposing jaws 18 toward each other, to close the jaws 18 on the tissue. RF energy and conductive fluid, such as saline, are applied through the device and to the treatment site, thereby heating the tissue to coagulate, or achieve the desired treatment of the tissue. If desired, after coagulating the tissue between the jaws, the jaws can be held clamped together and the cutting mechanism can be actuated to cut tissue.

[0096] FIG. 8 shows a schematic close-up section view of the two jaws 18 at the distal tip of the shaft 17. In a preferred embodiment, each jaw 18 includes an electrode 25, a manifold 24, and a plurality of holes 26 in the electrode. Each jaw 18 further includes a jaw surface 29 that contacts the tissue to be treated. In the embodiment illustrated in FIG. 8, the jaw surface 29 is textured, so that it is capable of grasping the tissue to be treated. However, the jaw surface 29 need not be textured, and can include any type of desired surface configuration, such as serrations and the like, or can be provided with a smooth surface. In use, saline flows in a manifold 24 in the direction of arrows 30, wherein the manifold 24 distributes saline flow evenly to a plurality of holes 26 that are made in the jaw 18. Preferably, most of the structural material of each jaw 18 is fabricated from a material that is non-conductive electrically, such as nylon or other polymer such as liquid crystal polymer. This non-conductive material is shown in the figure as reference number 27. Further, in some embodiments, the jaw surface 29 can be fabricated from a nonconductive material. In a preferred embodiment, each jaw 18 further includes a groove 28 that is recessed from the jaw surface 29. In this embodiment, after the saline flows through the holes 26, it flows in the groove 28. When tissue is grasped between the jaws, saline can flow in the groove 28 between the electrode and the tissue, and exit through exit grooves 62 that are open to the outside at the proximal end of the jaws 18.

[0097] FIG. 9 shows an overall schematic top view of the electrosurgical device shown in FIGS. 7 and 8. As shown in FIG. 9, the jaws 18 can be provided in a loop configuration. FIG. 10 shows a close-up section of one of the loop jaws 18. In this embodiment, the jaws 18 are provided in a loop configuration to create a space 30 that allows a cutting mechanism 31 to move proximally and distally within the space 30. One of skill in the art would comprehend that the electrode configuration shown in FIG. 9 is simply an exemplary configuration, and the electrode need not be formed of two loops. For example, the electrosurgical device need not include a cutting mechanism, and the electrodes in these embodiments would not be required to include a space or recess for passage of the cutting mechanism. The invention contemplates any suitable electrode configuration used to treat tissue with RF energy and conductive fluid.

[0098] If the saline that flows from one electrode to the other is not boiling in any significant manner, a large fraction of the RF energy can be diverted away from target tissue. This “stealing” of RF energy tends to dramatically slow down the process of coagulating tissue and producing the desired hemostasis or aerostasis of the tissue. This situation is illustrated in FIG. 11. In this embodiment, tissue 32 grasped between the jaws 18 does not fill the jaws. Areas 34 and 35 show areas of air between the jaws 18. Saline liquid flows from the top electrode jaw to the lower electrode jaw in several locations: at area 33, located at the distal end of the jaws 18, at locations between tissue 32 and area 34, and between areas 34 and 35. These locations of saline flow between areas 34 and 35 represent the closest gap between jaws (area 35) and flow of saline along the tissue boundary 32, which are the most likely areas for saline flow between the jaws 18. Since most of the saline is not boiled, excess saline 36 drips off the lower jaw.

[0099] The saline shunting scenario can also be explained by using an electrical circuit as shown in FIG. 11a. Electrically, the tissue and the saline fluid shunt can be modeled as resistors in parallel. Using Ohm's Law one can calculate the percentage of total RF power that is dissipated in the saline shunt as:

%  RF  Power = \frac{100}{[1 + R_{s} / R_{t}]}

[0100] In the embodiment illustrated in FIG. 11a, the total current (I) 50 from source 54 is split between two resistors, tissue electrical resistance (R_t), and saline shunt electrical resistance (R_s). This relationship is shown in the schematic graph of FIG. 11b, which shows the relationship of the ratio of saline to tissue resistance (R_s/R_t) to percent of power shunted into saline. As shown in the figure, when the resistance of the saline is equal to the tissue (R_s/R_t=1), half the power is shunted into the saline. For example, when the resistance of the saline is four times that of the tissue, then only 20% of the power is shunted into the saline.

[0101] One benefit of the flow rate control strategy described herein, where a high % boiling is maintained, is that the flow of saline from one electrode to the other is either eliminated altogether because all the flow boils off at the electrode/tissue interface, or a large fraction of the flow boils as it flows toward the other electrode. This second case is illustrated in FIG. 12, that is, where a large fraction of the saline flow boils as it flows toward the other electrode. Note that in comparison to FIG. 11, there is less saline flowing from the top jaw to the lower jaw, and where there is flow it is actively boiling, as indicated by the vapor bubbles shown in several locations 37 and 38. According to the invention, boiling of a large fraction of the saline assures that most of the RF power will be directed into the tissue to achieve coagulation in the fastest time.

[0102] One aspect of the control strategy of the invention is that the flow of saline is preferably primarily directed spatially against or very near the target tissue that is to receive the RF power. If the flow rate is not near where the RF power is turned into heat, the saline is not capable of protecting the tissue from desiccation by dissipating excess heat in the boiling process. Therefore, in a preferred embodiment, the flow of conductive fluid is directly primarily at the tissue treatment site.

[0103] Use

[0104] Typically a surgeon will grasp a small amount of tissue with the very tip of the device as shown in FIG. 13. If the electrode jaws are long relative to the length of the tissue segment being grasped, then saline exiting of holes 26 in the proximal part of the jaws may not be able to flow to the tip, but may leak out along the upper jaw. Though surface tension will act to keep saline flow in the groove 28, gravity can tend to cause the saline collect and flow down directly to the opposing jaw. This would result in the undesirable effects mentioned above. By providing two slidable gutters 39, the flow of saline can be collected and directed distally toward the tissue. In this embodiment, the saline can flow from one jaw to the other in areas 40, located on each side of the tissue being grasped, but with a large percentage boiling before reaching the other jaw. According to this embodiment, the gutters 39 can be fabricated from any material that is non-conducting, for example, plastic. The gutters can slide toward the distal end of the device as part of the activation of lever 21 shown in FIG. 7, to be stopped automatically by the presence of tissue. Alternatively the gutters 39 can be slid forward as part of a separate mechanism action. The gutters 39 can be fabricated from any suitable material that is non-conducting, for example, plastic.

[0105] FIG. 14 shows a schematic cross-sectional view of the gutters shown in FIG. 13. The cross-section in FIG. 14 illustrates the nonconducting portion 27 of the jaw 18, the saline manifold 24, the electrodes 25, holes 26, groove 28, space 30 for the cutting mechanism, and gutters 39. Near the distal end of the gutters, exit grooves 62 in the gutter can allow saline to flow through and onto the edge of the tissue even if the gutter is pressed snuggly against the tissue (shown in FIG. 8).

[0106] FIG. 15 and FIG. 16 illustrate an alternative embodiment of the electrosurgical device of the invention. In this embodiment, the electrosurgical device includes a mechanism for directing saline flow to where tissue is being heated using RF energy. Preferably, the mechanism for directing saline flow comprises one or more tissue activated valves. In FIG. 15, the jaw 18 of the device includes a pin 40 that is configured with a bulged portion 52 in the middle section of the plunger pin 40, so that the pin 40 can seat into a counter-sunk hole 26ain the electrode 25. Pin 40 preferably further includes a pin tip 41 that contacts tissue. Preferably, the pin tip 41 is rounded or atraumatic to reduce tissue trauma. As illustrated in the figure, counter-sunk hole 26aincludes a recessed portion 56 that is configured to receive the bulged portion 52, such that when seated within the recessed portion 56, the pin 40 prevents conductive fluid flow from the manifold 24 to the tissue being treated. Preferably, a guide tube 42 holds the pin 40 in position, and spring 43 provides force to push the bulged portion 52 of pin 40 into the recessed portion 56 and seal off the flow of saline from the manifold region 24. In use, the pin tip 41 contacts tissue when the jaws 18 compress tissue. When tissue is compressed, the tissue contacts the tip 41 and pushes the pin 40 upwards, unseating the bulged portion 52 of the pin 40 from the recessed portion 56, and allowing saline to flow in direction of arrows 44 through the annular space between the pin 40 and the counter-sunk hole 26a.

[0107] FIG. 16 shows a schematic view of one embodiment wherein a series of such tissue-activated valves functions to deliver saline flow only to areas of the jaws where tissue is compressed and to be RF-heated. Referring to FIGS. 15 and 16, tissue is compressed in the area labeled 60, and the holes 26aare open to allow saline flow to the tissue treatment site. As described above, tissue contacts tip 41, thereby pushing pin 40 upwards, unseating the bulged portion 52 of the pin 40 from the recessed portion 56 (shown in FIG. 15). This interaction allows saline to flow from the device 5ato the tissue being treated. In the area labeled 62 in the figure, tissue is not compressed between jaws 18 of the device 5a, and therefore the holes 26aare closed to the flow of saline from the device 5a. Because the tips 41 of pins 40 do not contact tissue, the pin 40 is not forced from its seated position within recessed portion 56 of the hole 26a(shown in FIG. 15).

[0108] Generally, the holes 26 or 26aof the electrode 25 supply conductive fluid to the treatment site. In an alternative embodiment, these holes are provided in the form of porous material such as metal. In this embodiment, the electrodes do not include discrete holes; rather, the electrode surface itself is porous to allow infusion of the conductive solution to the treatment site. Porous sintered metal is available in many materials (such as, for example, 316L stainless steel, titanium, Ni-Chrome, and the like) and shapes (such as cylinders, discs, plugs, and the like) from companies such as Porvair, located in Henderson, N.C.

[0109] Porous metal components can be formed by a sintered metal powder process or by injection molding a two-part combination of metal and a material that can be burned off to form pores that connect (open cell) to each other. Such methods are known in the art. In this embodiment, conductive fluid will flow out of the electrode everywhere the pores are open. Preferably, the exterior (that is, the portions of the components that do not comprise the portion of the device involved in tissue treatment) of such porous metal electrode components can be covered with a material that fills the pores and prevents both the flow of saline and the passing of electrical energy. Alternatively, the device can include gutters to prevent the flow of saline in areas where it is desired to prevent saline flow.

[0110] In yet another embodiment, a porous polymer is used in place of the porous metal. Although the polymer is non-conductive, the conductive solution provided will conduct the RF energy across the porous polymer wall and to the tissue to be treated. Suitable materials include high temperature open cell silicone foam and porous polycarbonates, among others. Porous ceramics also fall into this category, since they could distribute conductive fluid flow, withstand high temperatures and be machinable or moldable for manufacturing purposes. Preferably, the material used transmits both fluid flow and electrical energy; thus, materials with properties between high-electrical conductivity metals and low electrical conductivity polymers are also contemplated, such as porous carbon-filled polymers. In these embodiments, conductive fluid flow is distributed along the length of the electrodes, where porous material is used to fabricate the electrodes. All or a portion of the electrodes can be porous according to the invention.

[0111] While the invention has been described in relation to a bipolar electrosurgical device, it will be readily apparent that other electrosurgical devices can be easily adapted to be used in connection with the invention. For example, the electrosurgical device 5 in FIG. 1 can, in another embodiment, be provided as a monopolar device. In this embodiment, one of the wires going to the bipolar device would instead go to a ground pad dispersive electrode located on the patient's back or other suitable anatomical location. Minimally, the electrosurgical device will be capable of delivering RF power and conductive solution to tissue. For example, the device can comprise a straight needle having an interior lumen for transmitting conductive solution to the tissue. Alternatively, the electrosurgical device can comprise other configurations such as loops, forceps, blades, and the like.

[0112] Other suitable electrosurgical devices that can be used in connection with the invention described herein include, but are not limited to, devices described in U.S. patent application Ser. No. 09/668,403 (filed Sep. 22, 2000), U.S. Pat. No. 5,897,553 (issued Apr. 27, 1999), U.S. Pat. No. 6,063,081 (issued May 16, 2000), and U.S. Pat. No. 6,096,037 (issued Aug. 1, 2000).

[0113] Moreover, it will be readily apparent that other means can be used to provide heat to the tissue, in addition to the radio frequency power described herein.

[0114] One or more of the features of the previously described system can be built into a custom RF generator. This embodiment can provide one or more advantages. For example, this type of system can save space and reduce overall complexity for the user. This system can also enable the manufacturer to increase the power delivered into low impedance loads, thereby further reducing the time to achieve the desired tissue effects. This changes the curve of FIG. 5, by eliminating or reducing the slope of the low impedance ramp of power versus impedance.

[0115] To effectively treat thick tissues, it can be advantageous to have the ability to pulse the RF power on and off. Under some circumstances, the temperature deep in tissue can rise quickly past the 100° C. desiccation point even though the electrode/tissue interface is boiling at 100° C. This manifests itself as “popping,” as steam generated deep in the tissue boils too fast and erupts toward the surface. In one embodiment of the invention, a switch is provided on the control device or custom generator to allow the user to select a “pulse” mode of the RF power. Preferably, the RF power system in this embodiment is further controlled by software.

[0116] In some embodiments, it can be desirable to control the temperature of the conductive fluid before it is released from the electrosurgical device. In one embodiment, a heat exchanger is provided for the outgoing saline flow to either heat or chill the saline. Pre-heating the saline to a predetermined level below boiling reduces the transient warm-up time of the device as RF is initially turned on, thereby reducing the time to cause coagulation of tissue. Alternatively, pre-chilling the saline is useful when the surgeon desires to protect certain tissues at the electrode/tissue interface and treat only deeper tissue. One exemplary application of this embodiment is the treatment of varicose veins, where it is desirable to avoid thermal damage to the surface of the skin. At the same time, treatment is provided to shrink underlying blood vessels using thermal coagulation. The temperature of the conductive fluid prior to release from the surgical device can therefore be controlled, to provide the desired treatment effect.

[0117] In another embodiment, the flow rate controller is modified to provide for a saline flow rate that results in greater than 100% boiling at the tissue treatment site. For example, the selection switch 12 of the flow rate controller 11 (shown in FIG. 1) can include settings that correspond to 110%, 120% and greater percentages of boiling. These higher settings can be of value to a surgeon in such situations as when encountering thick tissue, wherein the thickness of the tissue can increase conduction away from the electrode jaws. Since the basic control strategy neglects heat conduction, setting for 100% boiling can result in 80% of 90% boiling, depending upon the amount of conduction. Given the teachings herein, the switch of the flow rate controller can accommodate any desirable flow rate settings, to achieve the desired saline boiling at the tissue treatment site.

[0118] Some embodiments of the invention can provide one or more advantages over current electrosurgical techniques and devices. For example, the invention preferably achieves the desired tissue effect (for example, coagulation, cutting, and the like) in a fast manner. In a preferred embodiment, by actively controlling the flow rate of saline, both in quantity (Q vs. P) and location (for example, using gutters to direct fluid distally to tissue, using holes to direct flow of fluid, or other similar methods) the electrosurgical device can create a hot non-desiccating electrode/tissue interface and thus a fast thermally induced tissue coagulation effect.

[0119] The invention can, in some embodiments, deliver fast treatment of tissue without using a temperature sensor built into the device or a custom special-purpose generator. In a preferred embodiment, there is no built-in temperature sensor or other type of tissue sensor, nor is there any custom generator. Preferably, the invention provides a means for controlling the flow rate to the device such that the device and flow rate controller can be used with a wide variety of general-purpose generators. Any general-purpose generator is useable in connection with the fluid delivery system and flow rate controller to provide the desired power; the flow rate controller will accept the power and constantly adjust the saline flow rate according to the control strategy. Preferably, the generator is not actively controlled by the invention, so that standard generators are useable according to the invention. Preferably, there is no active feedback from the device and the control of the saline flow rate is “open loop.” Thus, in this embodiment, the control of saline flow rate is not dependent on feedback, but rather the measurement of the RF power going out to the device.

[0120] In another aspect, the invention preferably provides an electrosurgical device design that is capable of quickly and effectively sealing a wide variety of tissue segment sizes. The electrosurgical device provides a number of characteristics that improve the ability to treat a wide variety of tissue size and thickness. For example, a preferred embodiment provides the ability to control the saline flow towards a high percentage boiling, for example, 80-100%. This reduces shunting of the RF by boiling off saline before it could flow to the other electrode, or by boiling the saline as it is in the process of flowing to the other electrode. In another aspect, one preferred embodiment includes gutters in connection with the electrodes. In this embodiment, saline flow is directed toward the tissue treatment site, thereby providing all or substantially all of the conductive fluid to the treatment site. Thus, the tissue being treated is sufficiently “protected” from desiccation by utilizing the controlled conductive fluid boiling described herein. Preferably, the tissue-activated jaws offer another way to provide the conductive fluid in proximity to where the RF power is turned into heat.

[0121] While a preferred embodiment of the present invention has been described, it should be understood that various changes, adaptations and modifications can be made therein without departing from the spirit of the invention and the scope of the appended claims. The scope of the invention should, therefore, be determined not with reference to the above description, but instead should be determined with reference to the appended claims along with their full scope of equivalents.

[0122] All publications and patent documents cited in this application are incorporated by reference in their entirety for all purposes to the extent they are not inconsistent with the teachings herein.

Claims

Certificate of Correction present

The claims shown below may not include correction changes. Use the corrected PDF for authoritative text.

We claim:

1. A system for treating tissue comprising:

a) a power measurement device;

b) a flow rate controller coupled to the power measurement device; and

c) an electrosurgical device configured and arranged to provide radio frequency power and conductive fluid to the tissue,

wherein the flow rate controller is configured and arranged to modify a flow rate of the conductive fluid to the tissue, based on signals from the power measurement device and heat used to warm the conductive fluid and heat used to convert the conductive fluid vapor.

2. The system according to claim 1 wherein the flow rate controller modifies the flow rare of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

where ρ is density of the conductive fluid that is heated, C_pis the specific heat of the conductive fluid, Q₁is the flow rate of the conductive fluid that is heated, ΔT is temperature rise of the conductive fluid, h_vis heat of vaporization of the conductive fluid, and Q_bis the flow rate of conductive fluid that boils.

3. The system according to claim 1 wherein the conductive fluid comprises saline and the flow rate controller is configured and arranged to modify the flow rate of saline.

4. The system according to claim 1 wherein the electrosurgical device comprises a bipolar electrosurgical device.

5. The system according to claim 1 further comprising a generator that provides radio frequency power to the electrosurgical device through the power measurement device.

6. A device for modifying flow rare of conductive fluid to tissue based on measurement of radio frequency power delivered to the tissue, the device comprising:

a flow rate controller configured and arranged to modify flow rate of the conductive fluid to the tissue, based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor.

7. The device according to claim 6 wherein the flow rate controller modifies the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

8. The device according to claim 6 wherein the conductive fluid comprises saline and the flow rate controller is configured and arranged to modify the flow rate of saline to the tissue.

9. A device for treating tissue using radio frequency power and conductive fluid, the device comprising:

a) a sensing device, and

b) a processor coupled to the sensing device, wherein the processor is configured and arranged to adjust flow rate of the conductive fluid to the tissue, by determining a level of radio frequency power applied to the tissue using the sensing device, and adjusting the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor.

10. The device according to claim 9 wherein the processor of the device is configured and arranged to adjust the flow rate of the conductive fluid to the tissue based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

where ρ is density of the conductive fluid that is heated, C_pis the specific heat of the conductive fluid, Q₁is the flow raze of the conductive fluid that is heated, ΔT is temperature rise of the conductive fluid, h_vis heat of vaporization of the conductive fluid, and Q_bis the flow rate of conductive fluid that boils.

11. The device according to claim 9 wherein the conductive fluid comprises saline and the device uses radio frequency power and saline to treat the tissue.

12. A system for treating tissue comprising:

a) a power measurement device;

b) a flow rate controller coupled to the power measurement device;

c) a flow control device coupled to the flow rate controller; and

d) an electrosurgical device coupled to the flow control device and the power measurement device, wherein the electrosurgical device is configured and arranged to provide radio frequency power and conductive fluid to the tissue,

wherein the flow rate controller is configured and arranged to modify a flow rate of the conductive fluid to the electrosurgical device, based on signals from the power measurement device and heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor.

13. The system according to claim 12 wherein the flow control device comprises a pump.

14. The system according to claim 13 wherein the pump comprises a peristaltic pump.

15. The system according to claim 13 wherein the pump comprises a syringe pump.

16. A system according to claim 12 wherein the flow rate controller is configured and arranged to modify the flow rate of the conductive fluid to the electrosurgical device based on heat used to warm the conductive fluid and heat used to convert the conductive fluid to vapor using the relationship:

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

17. The system according to claim 12 wherein the conductive fluid comprises saline and the electrosurgical device is configured and arranged to provide radio frequency power and saline to the tissue.

18. The system according to claim 12 wherein the electrosurgical device comprises a bipolar electrosurgical device.

19. The system according to claim 18 wherein the bipolar electrosurgical device comprises opposing jaws and slidable gutters disposed on the opposing jaws.

20. The system according to claim 18 wherein the bipolar electrosurgical device comprises a cutting mechanism.

21. The system according to claim 18 wherein the bipolar electrosurgical device comprises tissue activated valves.

22. A system for treating tissue comprising:

radio frequency power provided from a power source at a power level;

an electrically conductive fluid provided from a fluid source at a fluid flow rate;

an electrosurgical device configured to provide the radio frequency power with the electrically conductive fluid to the tissue; and

a flow rate controller configured to modify the fluid flow rate of the electrically conductive fluid based on boiling of the conductive fluid.

23. The system for treating tissue according to claim 22 wherein the fluid flow raze is modified based on one of initiating, increasing, decreasing and eliminating boiling of the conductive fluid.

24. The system for treating tissue according to claim 22 wherein the fluid flow rate is modified based on an amount of boiling of the conductive fluid.

25. The system for treating tissue according to claim 22 wherein the fluid flow rate is modified based on an onset of boiling of the conductive fluid.

26. A system for treating tissue comprising:

radio frequency power provided from a power source at a power level;

an electrically conductive fluid provided from a fluid source at a fluid flow rate;

an electrosurgical configured to provide the radio frequency power with the electrically conductive fluid to the tissue; and

a flow rate controller configured to modify the fluid flow rate of the electrically conductive fluid based on heat used to warm the conductive fluid to an onset of boiling and heat used to convert at least a portion of the conductive fluid to vapor.

27. A system for treating tissue comprising:

radio frequency power provided from a power source at a power level;

an electrically conductive fluid provided from a fluid source at a fluid flow rate;

an electrosurgical device configured to provide the radio frequency power with the electrically conductive fluid to the tissue; and

a flow rate controller configured to modify the fluid flow rate of the electrically conductive fluid based on one of initiating, increasing, decreasing and eliminating a boiling of the fluid.

28. A system for treating tissue comprising:

radio frequency power provided from a power source at a power level;

an electrically conductive fluid provided from a fluid source at a fluid flow rate;

an electrosurgical device configured to provide the radio frequency power with the electrically conductive fluid to the tissue; and

a flow rate controller configured to modify the fluid flow rate of the electrically conductive fluid based on an amount of boiling of the conductive fluid.

29. The system for treating tissue according to claim 22 wherein the fluid flow rate is modified in an open feedback loop.

30. The system for treating tissue according to claim 22 wherein the fluid flow rate from the flow rate controller is manually adjustable to modify the fluid flow rate.

Patent Citations (245)

Patent	Date	Inventor	Cited By
US623022(A)	1899-04-01	Johnson	Applicant
US2002594(A)	1935-05-01	Wappler et al.	Applicant
US3163166(A)	1964-12-01	Brent et al.	Applicant
US3901241(A)	1975-08-01	Allen, Jr.	Applicant
US4037590(A)	1977-07-01	Dohring et al.	Applicant
US4307720(A)	1981-12-01	Weber, Jr.	Applicant
US4326529(A)	1982-04-01	Doss et al.	Applicant
US4567890(A)	1986-02-01	Ohta et al.	Applicant
US4602628(A)	1986-07-01	Allen, Jr.	Applicant
US4674499(A)	1987-06-01	Pao	Applicant
US4920982(A)	1990-05-01	Goldstein	Applicant
US4985030(A)	1991-01-01	Melzer et al.	Applicant
US5009656(A)	1991-04-01	Reimels	Applicant
US5035696(A)	1991-07-01	Rydell	Applicant
US5071419(A)	1991-12-01	Rydell et al.	Applicant
US5122138(A)	1992-06-01	Manwaring	Applicant
US5151102(A)	1992-09-01	Kamiyama et al.	Applicant
US5156613(A)	1992-10-01	Sawyer	Applicant
US5167659(A)	1992-12-01	Ohtomo et al.	Applicant
US5190541(A)	1993-03-01	Abele et al.	Applicant
US5217460(A)	1993-06-01	Knoepfler	Applicant
US5242442(A)	1993-09-01	Hirschfeld	Applicant
US5269781(A)	1993-12-01	Hewell, III	Applicant
US5277696(A)	1994-01-01	Hagen	Applicant
US5282799(A)	1994-02-01	Rydell	Applicant
US5300087(A)	1994-04-01	Knoepfler	Applicant
US5318589(A)	1994-06-01	Lichtman	Applicant
US5322503(A)	1994-06-01	Desai	Applicant
US5334193(A)	1994-08-01	Nardella	Applicant
US5342357(A)	1994-08-01	Nardella	Applicant
US5364394(A)	1994-11-01	Mehl	Applicant
US5395312(A)	1995-03-01	Desai	Applicant
US5395363(A)	1995-03-01	Billings et al.	Applicant
US5401272(A)	1995-03-01	Perkins	Applicant
US5403311(A)	1995-04-01	Abele et al.	Applicant
US5403312(A)	1995-04-01	Yates et al.	Applicant
US5405376(A)	1995-04-01	Mulier et al.	Applicant
US5431649(A)	1995-07-01	Mulier et al.	Applicant
US5433708(A)	1995-07-01	Nichols et al.	Applicant
US5437664(A)	1995-08-01	Cohen et al.	Applicant
US5456682(A)	1995-10-01	Edwards et al.	Applicant
US5458596(A)	1995-10-01	Lax et al.	Applicant
US5458597(A)	1995-10-01	Edwards et al.	Applicant
US5458598(A)	1995-10-01	Feinberg et al.	Applicant
US5462521(A)	1995-10-01	Brucker et al.	Applicant
US5472441(A)	1995-12-01	Edwards et al.	Applicant
US5514130(A)	1996-05-01	Baker	Applicant
US5536267(A)	1996-07-01	Edwards et al.	Applicant
US5542928(A)	1996-08-01	Evans et al.	Applicant
US5558671(A)	1996-09-01	Yates	Applicant
US5562703(A)	1996-10-01	Desai	Applicant
US5569242(A)	1996-10-01	Lax et al.	Applicant
US5584872(A)	1996-12-01	LaFontaine et al.	Applicant
US5605539(A)	1997-02-01	Buelna et al.	Applicant
US5609151(A)	1997-03-01	Mulier et al.	Applicant
US5637110(A)	1997-06-01	Pennybacker et al.	Applicant
US5643197(A)	1997-07-01	Brucker et al.	Applicant
US5647871(A)	1997-07-01	Levine et al.	Applicant
US5653692(A)	1997-08-01	Masterson et al.	Applicant
US5660836(A)	1997-08-01	Knowlton	Applicant
US5676693(A)	1997-10-01	LaFontaine	Applicant
US5681282(A)	1997-10-01	Eggers et al.	Applicant
US5683366(A)	1997-11-01	Eggers et al.	Applicant
US5683384(A)	1997-11-01	Gough et al.	Applicant
US5697281(A)	1997-12-01	Eggers et al.	Applicant
US5697536(A)	1997-12-01	Eggers et al.	Applicant
US5697882(A)	1997-12-01	Eggers et al.	Applicant
US5697909(A)	1997-12-01	Eggers et al.	Applicant
US5697927(A)	1997-12-01	Imran et al.	Applicant
US5713896(A)	1998-02-01	Nardella	Applicant
US5718701(A)	1998-02-01	Shai et al.	Applicant
US5725524(A)	1998-03-01	Mulier et al.	Applicant
US5735846(A)	1998-04-01	Panescu et al.	Applicant
US5746739(A)	1998-05-01	Sutter	Applicant
US5749869(A)	1998-05-01	Lindenmeier et al.	Applicant
US5755753(A)	1998-05-01	Knowlton	Applicant
US5766153(A)	1998-06-01	Eggers et al.	Applicant
US5800482(A)	1998-09-01	Pomeranz et al.	Applicant
US5807395(A)	1998-09-01	Mulier et al.	Applicant
US5810764(A)	1998-09-01	Eggers et al.	Applicant
US5827271(A)	1998-10-01	Buysse et al.	Applicant
US5833703(A)	1998-11-01	Manushakian	Applicant
US5843019(A)	1998-12-01	Eggers et al.	Applicant
US5843078(A)	1998-12-01	Sharkey	Applicant
US5843152(A)	1998-12-01	Tu et al.	Applicant
US5860951(A)	1999-01-01	Eggers et al.	Applicant
US5860974(A)	1999-01-01	Abele	Applicant
US5861002(A)	1999-01-01	Desai	Applicant
US5868739(A)	1999-02-01	Lindenmeier et al.	Applicant
US5871469(A)	1999-02-01	Eggers et al.	Applicant
US5873855(A)	1999-02-01	Eggers et al.	Applicant
US5876398(A)	1999-03-01	Mulier et al.	Applicant
US5888198(A)	1999-03-01	Eggers et al.	Applicant
US5891095(A)	1999-04-01	Eggers et al.	Applicant
US5895417(A)	1999-04-01	Pomeranz et al.	Applicant
US5897553(A)	1999-04-01	Mulier et al.	Applicant
US5902272(A)	1999-05-01	Eggers et al.	Applicant
US5902328(A)	1999-05-01	LaFontaine et al.	Applicant
US5906613(A)	1999-05-01	Mulier et al.	Applicant
US5913854(A)	1999-06-01	Maguire et al.	Applicant
US5913856(A)	1999-06-01	Chia et al.	Applicant
US5954716(A)	1999-09-01	Sharkey et al.	Applicant
US5964755(A)	1999-10-01	Edwards	Applicant
US5976128(A)	1999-11-01	Schilling et al.	Applicant
US5980516(A)	1999-11-01	Mulier et al.	Applicant
US5992418(A)	1999-11-01	de la Rama et al.	Applicant
US6015407(A)	2000-01-01	Rieb et al.	Applicant
US6016809(A)	2000-01-01	Mulier et al.	Applicant
US6017338(A)	2000-01-01	Brucker et al.	Applicant
US6024733(A)	2000-02-01	Eggers et al.	Applicant
US6027501(A)	2000-02-01	Goble et al.	Applicant
US6030379(A)	2000-02-01	Panescu et al.	Applicant
US6032077(A)	2000-02-01	Pomeranz	Applicant
US6032674(A)	2000-03-01	Eggers et al.	Applicant
US6045532(A)	2000-04-01	Eggers et al.	Applicant
US6047700(A)	2000-04-01	Eggers et al.	Applicant
US6053172(A)	2000-04-01	Hovda et al.	Applicant
US6053912(A)	2000-04-01	Panescu et al.	Applicant
US6056745(A)	2000-05-01	Panescu et al.	Applicant
US6056747(A)	2000-05-01	Saadat et al.	Applicant
US6063079(A)	2000-05-01	Hovda et al.	Applicant
US6063081(A)	2000-05-01	Mulier et al.	Applicant
US6066134(A)	2000-05-01	Eggers et al.	Applicant
US6071280(A)	2000-06-01	Edwards et al.	Applicant
US6080151(A)	2000-06-01	Swartz et al.	Applicant
US6086585(A)	2000-07-01	Hovda et al.	Applicant
US6093186(A)	2000-07-01	Goble	Applicant
US6096037(A)	2000-08-01	Mulier et al.	Applicant
US6102046(A)	2000-08-01	Weinstein et al.	Applicant
US6105581(A)	2000-08-01	Eggers et al.	Applicant
US6109268(A)	2000-08-01	Thapliyal et al.	Applicant
US6113597(A)	2000-09-01	Eggers et al.	Applicant
US6117109(A)	2000-09-01	Eggers et al.	Applicant
US6135999(A)	2000-10-01	Fanton et al.	Applicant
US6142992(A)	2000-11-01	Cheng et al.	Applicant
US6149620(A)	2000-11-01	Baker et al.	Applicant
US6159194(A)	2000-12-01	Eggers et al.	Applicant
US6159208(A)	2000-12-01	Hovda et al.	Applicant
US6168594(B1)	2001-01-01	LaFontaine et al.	Applicant
US6171275(B1)	2001-01-01	Webster, Jr.	Applicant
US6174308(B1)	2001-01-01	Goble et al.	Applicant
US6174309(B1)	2001-01-01	Wrublewski et al.	Applicant
US6176857(B1)	2001-01-01	Ashley	Applicant
US6179824(B1)	2001-01-01	Eggers et al.	Applicant
US6179836(B1)	2001-01-01	Eggers et al.	Applicant
US6183469(B1)	2001-02-01	Thapliyal et al.	Applicant
US6190381(B1)	2001-02-01	Olsen et al.	Applicant
US6203542(B1)	2001-03-01	Ellsberry et al.	Applicant
US6210402(B1)	2001-04-01	Olsen et al.	Applicant
US6210411(B1)	2001-04-01	Hofmann et al.	Applicant
US6216704(B1)	2001-04-01	Ingle et al.	Applicant
US6217576(B1)	2001-04-01	Tu et al.	Applicant
US6221039(B1)	2001-04-01	Durgin et al.	Applicant
US6224592(B1)	2001-05-01	Eggers et al.	Applicant
US6226554(B1)	2001-05-01	Tu et al.	Applicant
US6228078(B1)	2001-05-01	Eggers et al.	Applicant
US6228082(B1)	2001-05-01	Baker et al.	Applicant
US6231591(B1)	2001-05-01	Desai	Applicant
US6235020(B1)	2001-05-01	Cheng et al.	Applicant
US6236891(B1)	2001-05-01	Ingle et al.	Applicant
US6238391(B1)	2001-05-01	Olsen et al.	Applicant
US6238393(B1)	2001-05-01	Mulier et al.	Applicant
US6241753(B1)	2001-06-01	Knowlton	Applicant
US6254600(B1)	2001-07-01	Willink et al.	Applicant
US6258086(B1)	2001-07-01	Ashley et al.	Applicant
US6261311(B1)	2001-07-01	Sharkey et al.	Applicant
US6264650(B1)	2001-07-01	Hovda et al.	Applicant
US6264651(B1)	2001-07-01	Underwood et al.	Applicant
US6264652(B1)	2001-07-01	Eggers et al.	Applicant
US6277112(B1)	2001-08-01	Underwood et al.	Applicant
US6280440(B1)	2001-08-01	Gocho	Applicant
US6283961(B1)	2001-09-01	Underwood et al.	Applicant
US6290715(B1)	2001-09-01	Sharkey et al.	Applicant
US6293942(B1)	2001-09-01	Goble et al.	Applicant
US6296636(B1)	2001-10-01	Cheng et al.	Applicant
US6296638(B1)	2001-10-01	Davison et al.	Applicant
US6302903(B1)	2001-10-01	Mulier et al.	Applicant
US6306134(B1)	2001-10-01	Goble et al.	Applicant
US6309387(B1)	2001-10-01	Eggers et al.	Applicant
US6312408(B1)	2001-11-01	Eggers et al.	Applicant
US6315777(B1)	2001-11-01	Comben	Applicant
US6322549(B1)	2001-11-01	Eggers et al.	Applicant
US6327505(B1)	2001-12-01	Medhkour et al.	Applicant
US6328735(B1)	2001-12-01	Curley et al.	Applicant
US6328736(B1)	2001-12-01	Mulier et al.	Applicant
US6336926(B1)	2002-01-01	Goble	Applicant
US6350276(B1)	2002-02-01	Knowlton	Applicant
US6355032(B1)	2002-03-01	Hovda et al.	Applicant
US6358248(B1)	2002-03-01	Mulier et al.	Applicant
US6363937(B1)	2002-04-01	Hovda et al.	Applicant
US6379350(B1)	2002-04-01	Sharkey et al.	Applicant
US6379351(B1)	2002-04-01	Thapliyal et al.	Applicant
US6391025(B1)	2002-05-01	Weinstein et al.	Applicant
US6402742(B1)	2002-06-01	Blewett et al.	Applicant
US6409722(B1)	2002-06-01	Hoey et al.	Examiner
US6409723(B1)	2002-06-01	Edwards	Applicant
US6416507(B1)	2002-07-01	Eggers et al.	Applicant
US6416508(B1)	2002-07-01	Eggers et al.	Applicant
US6425877(B1)	2002-07-01	Edwards	Applicant
US6432103(B1)	2002-08-01	Ellsberry et al.	Applicant
US6461350(B1)	2002-10-01	Underwood et al.	Applicant
US6461354(B1)	2002-10-01	Olsen et al.	Applicant
US6461357(B1)	2002-10-01	Sharkey et al.	Applicant
US6464695(B2)	2002-10-01	Hovda et al.	Applicant
US6468270(B1)	2002-10-01	Hovda et al.	Applicant
US6468274(B1)	2002-10-01	Alleyne et al.	Applicant
US6493589(B1)	2002-12-01	Medhkour et al.	Applicant
US2001/0020167(A1)	2001-09-01	Woloszko et al.	Applicant
US2002/0002393(A1)	2002-01-01	Mitchell	Applicant
US2002/0022870(A1)	2002-02-01	Truckai et al.	Applicant
US2002/0026186(A1)	2002-02-01	Woloszko et al.	Applicant
US2002/0029036(A1)	2002-03-01	Goble et al.	Applicant
US2002/0035361(A1)	2002-03-01	Houser et al.	Applicant
US2002/0049438(A1)	2002-04-01	Sharkey et al.	Applicant
US2002/0049439(A1)	2002-04-01	Mulier et al.	Applicant
US2002/0058933(A1)	2002-05-01	Christopherson et al.	Applicant
US2002/0058935(A1)	2002-05-01	Hoey et al.	Applicant
US2002/0095150(A1)	2002-07-01	Goble	Applicant
US2002/0095151(A1)	2002-07-01	Dahla et al.	Applicant
US2002/0095152(A1)	2002-07-01	Ciarrocca et al.	Applicant
US2002/0099366(A1)	2002-07-01	Dahla et al.	Applicant
US2002/0115991(A1)	2002-08-01	Edwards	Applicant
US2002/0115992(A1)	2002-08-01	Utley et al.	Applicant
US2003/0004510(A1)	2003-01-01	Wham et al.	Applicant
EP895756	1999-02-01		Applicant
EP1095627	2001-05-01		Applicant
EP11576660	2001-11-01		Applicant
JP57-117843	1982-07-01		Applicant
WO90/03152	1990-04-01		Applicant
WO94/02077	1994-02-01		Applicant
WO94/26228	1994-11-01		Applicant
WO95/05781	1995-03-01		Applicant
WO95/09570	1995-04-01		Applicant
WO95/17222	1995-06-01		Applicant
WO96/34571	1996-11-01		Applicant
WO97/05829	1997-02-01		Applicant
WO97/16127	1997-05-01		Applicant
WO98/14131	1998-04-01		Applicant
WO99/03414	1999-01-01		Applicant
WO99/20213	1999-04-01		Applicant
WO99/58070	1999-11-01		Applicant
WO1/26570	2001-04-01		Applicant
WO1/28444	2001-04-01		Applicant
WO1/35845	2001-05-01		Applicant
WO1/60273	2001-08-01		Applicant

Non-Patent Literature (9)

Beer, Edwin, “Removal of Neoplasms of the Urinary Bladder”, JAMA., Sep. 9, 1983; 250(10): pp. 1324-1325.Applicant
Carter, James, “Suture? Staple? Electrosurgery? How to Decide What is Best For You”, JSLS., Apr.-Jun., 1997; 1(2): pp. 171-174.Applicant
Matek et al., “Modified Electrocoagulation and Its Possibilities in the Control of Gastrointestinal Bleeding”, Endoscopy., Nov., 1979; 11(4): pp. 253-258.Applicant
Mittleman et al., “Use of the Saline Infusion Electrode Catheter for Improved Energy Delivery and Increased Lesion Size in Radiofrequency Catheter Ablation”, PACE., May 1995;18(5 Pt 1): pp. 1022-1027.Applicant
Sakatani et al., “Isotonic Mannitol and the Prevention of Local Heat Generation and Tissue Adherence to Bipolar Diathermy Forceps Tips during Electrical Coagulation”, J. Neurosurg., Apr. 1995; 82(4): pp. 669-671.Applicant
Takao, T., “Effect of Cautery with Irrigation Forceps on the Remnant Liver after Hepatectomy in Rats”, Eur. Surg. Res., 1999; 31(2): pp. 173-179.Applicant
Yasargil, M.G., “Microsurgery Applied to Neurosurgery”, New York: Academic Press, 1969, pp. 41-45.Applicant
Yamamoto et al., “New Simple Technique for Hepatic Parenchymal Resection Using a Cavitron Ultrasonic Surgical Aspirator and Bipolar Cautery Equipped with a Channel for Water Dripping”, World. J. Surg., Oct. 1999; 23(10): pp. 1032-1037.Applicant
Application No. 09/347,635, “Apparatus and Method for Creating, Maintaining, and Controlling a Virtual Electrode Used for the Ablation of Tissue”, Hoey et al., filed Jul. 6, 1999.Applicant

Abstract

Description

[0002] This application claims the benefit of priority of U.S. Application Serial No. 60/187,114, filed Mar. 6, 2000, the entire disclosure of which is incorporated herein by reference.

Field of the Invention

Background of the Invention

Summary of the Invention

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}

K = \frac{1}{{ρ c_{p} Δ T + ρ h_{v} Q_{b} / Q_{l}}}