Vascular tissue sealing pressure control

1.

Field of the Invention

0001A clamping force mechanism for an instrument allows a user to apply force within an preferred range to hold particular vascular tissue of a patient during application of electrosurgical energy to seal and /or join the particular tissue.

2.

Background of the Disclosure

0002Sealing and/or joining of particular vascular tissue during surgery is an essential part of an operation or procedure. Sutures, staples and adhesives have been used with varying levels of success. These prior techniques and the material and equipment used fail to minimize or limit the damage to the particular tissue and most importantly do not eliminate foreign body reactions of the patient to the added material. Specifically, the reaction of the patient's body is normally to surround the foreign body, i.e. added scar tissue, with barrier cells to thereby isolate the foreign matter from the normal cells within the patient. Consequently, the scar or evidence of the trauma is increased in size. The added material increases the cost of any surgical operation or procedure and post surgical concerns and healing.

0003Vascular tissue sealing and/or joining is important to the minimization of and/or elimination of bleeding or to the reconnection of tissue structures after surgical removal of undesirable organs or growths. Electrosurgery has been used to cut and coagulate tissue but the control needed to cleanly seal and /or join cut tissue and coagulate the bleeders has been lacking particularly in highly vascularized tissue, i.e. the particular patient tissue of interest and concern herein. Specifically, various approaches to coagulation, fulguration, cauterization for forming minimal and or flexible eschar over the bleeders have been tried. Different high frequency waveforms for coagulation by electrosurgical energy, argon gas enhanced coagulation and non sticking electrosurgical electrodes have been designed manufactured and sold with varying degrees of success at reducing healing time and the amount of evidence of surgical intrusion. All of the foregoing increases cost and complexity of surgical healing.

0004<patcit id="pcit0001" dnum="US4043342A"><text>U.S. Patent 4,043,342</text></patcit> has electrosurgical implements with sesquipolar electrode structures with active and return electrodes supported by insulated connectors respectively spring biased.

0005<patcit id="pcit0002" dnum="WO9313719A"><text>WO 9313719</text></patcit> has an electrosurgical instrument including a support structure with two electrodes interconnected with it to allow relative motion there between. A biasing device, such as a spring, urges the current return electrode into contact with tissue when the active electrode is positioned for surgery. The return electrode is longitudinally and laterally movable relative to the active electrode. A signal source provides a tissue cutting signal and a coagulation signal. The current return electrode has a tissue contact surface which defines a planar interface with the tissue during surgery. The active electrode is transversely movable relative to the interface. It increases contact surface to reduce likelihood of tissue damage and to easily control cutting depth. <patcit id="pcit0003" dnum="US5047027A"><text>U.S. Patent 5,047,027</text></patcit> has a bipolar electrosurgical instrument designed for resecting tumorous growths from the esophagus bladder or other internal organ wherein the site of the tumor is reached by way of an endoscope. The cutter is dimensioned to fit down the central lumen of the endoscope. An elongated flexible tube has a conductive helical spring cantilevered from the distal end of the tube, forming a return electrode and conductive wire hoop spaced a predetermined gap distance from the distalmost convolution of the helical spring and whose plane is perpendicular to the longitudinal axis of the flexible tube forms the active electrode.

0006Wires for applying a high frequency RF voltage across the electrodes extend through the lumen of the flexible tube. As the distal end portion of the instrument is dragged over the tumor to be resected, the cantilevered helical spring is laterally displaced, allowing the RF current leaving the active hoop electrode to cut through the tumorous tissue.

0007<patcit id="pcit0004" dnum="US5007908A"><text>U.S. Patent 5,007,908</text></patcit> has an instrument with an elongate flexible tubular member having a proximal end, a distal end and multiple lumens extending between them. Affixed to the distal end of the tube is a bullet-shaped ceramic tip member having a centrally-disposed longitudinal bore passing through the side wall of the tip member. The ceramic exterior surface of the tip member is covered with a conductive layer forming a first inactive electrode. An electrical conductor joined to that electrode surface feeds back through a lumen of the tube to its proximal end where it may be coupled to an electrosurgical generator. Also running a through a lumen in the tube is another conductor which can be made to project outwardly through the opening in the top member. A hub having a spring-loaded plunger is affixed to the proximal end of the tube with the plunger joined to the wire so that when the plunger is depressed the distal end of the wire will project a short distance beyond the extremity of the tip member. By coupling this second conductor to an electrosurgical generator, it becomes the active electrode of a bipolar pair.

0008<patcit id="pcit0005" dnum="US5290286A"><text>U.S. Patent 5,290,286</text></patcit> has an electrosurgical instrument with a bipolar pair of conductive electrodes for the cutting of tissue in which at least one electrode is moveable in relation to the other. The electrodes are mounted relative to an insulating plug, which is secured at the distal end of a tubular member. Pressure exerted on a thumb loop shifts the position of one electrode relative to the other. Upon application of RF voltage, the distance at which the electrodes are placed controls the amount of arcing which will occur between electrodes, when placed within a proper range. The electrodes are supplied with power from a standard RF energy source, controlled from a foot or hand switch. The insulating plug may further include metal traces disposed on the peripheral surface. When energized, these traces function as a bipolar pair of electrodes for effecting electrocoagulation of tissue and blood. The instrument is for insertion in laparoscopic trocar or endoscope for trimming small polyps from wall of colon and removal of tissue, and coagulating particular vascular tissue areas.

0009<patcit id="pcit0006" dnum="US5342357A"><text>U.S. Patent 5,342,357</text></patcit> has a cauterization system with a radio frequency energy source including a control unit connected to the energy source, and an electrosurgical probe. The probe has a handle with an elongate member extending from the handle. The distal end of the elongate member is tapered and includes a cauterization tip and a retractable cutting electrode. The probe includes a conduit for the transmission of cooling fluid to the distal end. The temperature of the electrode on the distal end of the probe is monitored and is used to control the rate of flow of the cooling fluid to the tip. A generator supplies electrical energy to the electrodes and the impedance of the tissue between the electrode is monitored to prevent tissue damage due to high temperatures. The system controls transfer of heat to tissue during surgery and prevents tissue or coagulant from welding to energy delivering electrode.

0010The document <patcit id="pcit0007" dnum="WO9507662A"><text>WO-A-95/07662</text></patcit> discloses a surgical instrument comprising a handle assembly with a detachable tool assembly. The tool assembly comprises pivotable jaws. The jaws are coupled to the distal end of an inner rod which is longitudinally translatable within an outer sleeve. When the inner rod is translated, a guid member at the distal end of the outer sleeve contacts the jaws such that each jaw rotates. The handle assembly comprises a trigger which engages a translation member on the inner rod. As the trigger is rotated, the translation member carries the inner and forth to actuate the jaws. The translation member is coupled to the inner rod via a coupler having a spring which limits the closing force applied to the jaws. The instrument also includes a ratchet feature function which allows closing force to be applied to the jaws in increments and also allows the jaws to be held in a closed position at a desired closing force.

0011None of the aforementioned equipment has offered the surgeon the level of control needed to remodel and reform the tissue with electrosurgical energy. No mechanism for the application of clamping pressure, electrosurgical energy and temperature to seal and/or join vascularized tissue has been found. The tissue of the patient includes collagen which has been found to bind an injury or wound, surgical or otherwise, when subject to adequate pressure and temperature. Collagen can be melted and resolidified into a load resistant natural tissue coagulant so the reformed structure is capable of enduring loads similar to that carried by uncut tissue. No mechanism for the adequate and proper application of temperature and pressure is known.

0012In the passages below, various methods are described. These methods are realisable with the subject matter of the present invention. For the avoidance of doubt, it is here stated that the claims are not directed to subject matter within the scope of Art. 53 (C) EPC.

<u>SUMMARY OF THE INVENTION</u>

0013The invention is defined in claim 1 below. The dependent claims are directed to optional or preferred features. A clamping force mechanism for a clamping electrosurgical instrument allows a user to seal and/or join particular vascular tissue of a patient. The clamping force mechanism includes an elongate support having user and patient ends. An actuator is at the user end and a pair of the end effectors is at the patient end so the pair of end effectors when connected to the actuator operate from the user end to control the motion of the end effectors. The pair of end effectors each have an opposing face of an area for contact with the particular vascular tissue of the patient.

0014A lost motion connection is between the end effectors and the actuator to transfer user manipulation of the actuator to the end effectors and for maintaining predetermined clamping force applications during journey and/or sealing the particular vascular tissue of the patient. A yielding member is included in the loss motion connection so the opposing faces clamp the particular tissue of the patient therebetween with force from the yielding member. The yielding member may in the preferred embodiment include a spring located near the actuator at the user end.

0015An elongated transfer rod in the lost motion connection is preferably between the spring near the actuator and the end effectors at the patient end for movement thereof between an open position for receiving the particular tissue of the patient to a clamping position for maintaining the predetermined force on the particular tissue of the patient between the end effectors. A locking linkage coupled to the actuator and the yielding member retains the opposing faces held against the particular tissue of the patient therebetween with the force from the yielding member to achieve the predetermined force. Stepped latching positions on the actuator permit the user to selectively set the locking linkage and the yielding member establishing different levels of force for the particular vascular tissue sealed to retain the set force in accord with the particular tissue being sealed. The stepped latching positions are associated with different particular vascular tissue including as arteries and veins and optionally mesentary.

0016An active electrode is carried on one of the end effectors. A return electrode also is included for contacting the tissue of the patient. An electrosurgical energy supply connects across the active electrode and the return electrode to deliver electrosurgical energy between and across the active electrode and the return electrode when the particular tissue of the patient is held by the end effectors. The electrosurgical energy supply may include an electrosurgical generator.

0017A feedback circuit can be in the electrosurgical generator and in circuit with the active and the return electrodes to respond to parameters indicative of energy delivery through the particular vascular tissue of the patient interposed between the active and return electrodes.

0018A temperature sensor may also be in the feedback circuit and preferably carried on one of the opposed faces; the sensor to respond to the temperature of the particular vascular tissue of the patient between the opposed faces during delivery of electrosurgical energy. An impedance monitor in the feedback circuit can also be electrically hooked up to the electrosurgical generator to respond to the impedance changes of the particular vascular tissue of the patient between the active and return electrode during delivery of electrosurgical energy.

0019A control associated with the electrosurgical energy supply most preferably applies electrosurgical energy to the held particular tissue of the patient in response to the application of the predetermined force for the sealing the particular tissue between the end effectors.

0020Alternatively, in a bipolar circuit the return electrode could be on one of the pair of end effectors opposite the active electrode. Optionally, the return electrode might be on one of the pair of end effectors that carries the active electrode with an electrical insulator disposed between those active and the return electrodes. Similarly, the return electrode may be a pad connected to the tissue of the patient and this is a monopolar circuit.

0021The yielding member might be a hydraulic coupling as part of the lost motion connection between the end effectors. The hydraulic coupling can be located near the actuator. The yielding member could be a slip clutch within the lost motion connection near the actuator at the user end.

0022The pair of end effectors may have opposing faces each of an equal and preset area to clamp the particular tissue of the patient therebetween with the force from the yielding member so that a force is applied to the particular tissue in a preferred range.

0023A method allows a user to clamp and apply force and electrosurgical energy to seal and/or join particular vascular tissue of a patient with the clamping force mechanism for the instrument. The steps of the method may include transferring user manipulation of the actuator to the pair of end effectors with the lost motion connection, maintaining with the lost motion connection predetermined clamping force application during sealing of the particular tissue between the end effectors and applying electrosurgical energy for sealing the held particular tissue of the patient in response to the clamping thereof between the end effectors with a control associated with the electrosurgical energy supply.

0024The method step of applying electrosurgical energy can include responding to the parameter of the temperature of the particular tissue of the patient between the end effectors during delivery of electrosurgical energy with the feedback circuit including the temperature sensor carried on one of the opposed faces.

0025The method step of applying electrosurgical energy may be limited by the impedance of the particular tissue of the patient between the active and return electrodes during delivery of electrosurgical energy with the impedance monitor.

0026The method step of maintaining the predetermined clamping force during sealing of the particular tissue may be performed by shifting the yielding member so the opposing faces clamp the particular tissue of the patient therebetween with force from the yielding member.

0027The method step of shifting preferably secures the predetermined clamping force during sealing of the particular tissue by the resilient bias from the yielding member and by most preferably including the step of urging with the spring.

0028The method step of shifting could alternately secure the predetermined clamping force during sealing of the particular tissue by the yielding member with the step of moving the end effectors between their open position for receiving the particular tissue to the clamping position with the elongated transfer rod.

0029The method step of shifting with the actuator may secure the predetermined clamping force during sealing of the particular tissue of the patient by the resilient bias of the yielding member with the alternative step of urging with the hydraulic coupling.

0030The method step of shifting with the actuator can secure the predetermined clamping force during sealing of the particular tissue by the resilient bias of the yielding member with the step of urging with the slip clutch.

0031The method step of maintaining the predetermined clamping pressure during sealing particular tissue with the step of using the force from the yielding member so that pressures within a preferred range may be achieved with the locking linkage.

<u>BRIEF DESCRIPTION OF THE DRAWINGS</u>

0032<ul id="ul0001" list-style="none" compact="compact"><li><figref idref="f0001">Figure 1</figref> is a schematic view of an electrosurgical supply and circuit for a clamping force mechanism to allow a user to apply force within an preferred range to hold particular vascular tissue of a patient during application of electrosurgical energy to seal and /or join the particular vascular tissue.</li><li><figref idref="f0002">Figure 2</figref> is a side view in partial cross section taken along lines 2-2 of <figref idref="f0001">Figure 1</figref> and showing the clamping force mechanism wherein a spring is used as a lost motion connection between the user and end effectors shown herein in a fully open position.</li><li><figref idref="f0003">Figure 3</figref> is a side view in partial cross section taken along lines 3-3 of <figref idref="f0001">Figure 1</figref> and showing the clamping force mechanism wherein the end effectors are shown in closed position.</li><li><figref idref="f0004">Figure 4</figref> is a side view in partial cross section taken along lines 4-4 of <figref idref="f0001">Figure 1</figref> and showing the clamping force mechanism wherein the end effectors are in partially compressed position.</li><li><figref idref="f0005">Figure 5</figref> is a side view in partial cross section taken along lines 5-5 of <figref idref="f0001">Figure 1</figref> and showing the clamping force mechanism wherein the end effectors are in the fully closed compressed position actuator and the pair of end effectors.</li><li><figref idref="f0006">Figure 6</figref> is a partial schematic view of the hydraulic coupling for the lost motion connection.</li><li><figref idref="f0006">Figure 7</figref> is a partial schematic view of the slip clutch for the lost motion connection.</li></ul>

<u>DETAILED DESCRIPTION OF THE INVENTION</u>

0033A clamping force mechanism 10 of an instrument allows a user to clamp and apply force and electrosurgical energy to seal and /or join particular vascular tissue of a patient 11, in <figref idref="f0001">Figure 1</figref>. The clamping force mechanism 10 includes an elongate support 12 particularly good for endoscopic procedures having a user end 13 and a patient end 14. An actuator 15 is at the user end 13 or operation by the user. A pair of the end effectors 16 is at the patient end 14 and the pair of end effectors 16 connect to the actuator 15 for operation thereby and from the user end 13 to control the motion of the pair of end effectors 16. The pair of end effectors 16 each have an opposing face 17 of an area for contact with the particular tissue of the patient 11 as shown in <figref idref="f0002">Figures 2</figref>, <figref idref="f0003">3</figref>, <figref idref="f0004">4</figref> and <figref idref="f0005">5</figref>.

0034A lost motion connection 18 is positioned between the pair of end effectors 16 at the patient end 14 and the actuator 15 at the user end 13, in <figref idref="f0002">Figures 2</figref>, <figref idref="f0003">3</figref>, <figref idref="f0004">4</figref> and <figref idref="f0005">5</figref>. The lost motion connection 18 transfers user manipulation of the actuator 15 to the pair of end effectors 16 for maintaining a predetermined clamping force application during sealing the particular tissue of the patient 11 between the pair of end effectors 16. A yielding member 19 is in the loss motion connection 18 so the opposing faces 17 clamp the particular vascular tissue of the patient 11 therebetween with force from the yielding member 19. The yielding member 19 includes a spring 20, as part of the lost motion connection 18, between the pair of end effectors 16 at the patient end 14 and the actuator 15 at the user end 13. The spring 20 is located near the actuator 15 at the user end 13.

0035An elongated transfer rod 21 connected to the lost motion connection 18 is located between the spring 20 near the actuator 15 and the pair of end effectors 16 at the patient end 14, in <figref idref="f0002">Figures 2</figref>, <figref idref="f0003">3</figref>, <figref idref="f0004">4</figref> and <figref idref="f0005">5</figref>. The rod 21 couples to the pair of end effectors 16 for movement thereof between an open position in <figref idref="f0002">Figure 2</figref> for receiving the particular tissue of the patient 11 to a clamping position for maintaining the predetermined force on the particular tissue of the patient 11 between the pair of the end effectors 16.

0036In <figref idref="f0002">Figures 2</figref>, <figref idref="f0003">3</figref>, <figref idref="f0004">4</figref> and <figref idref="f0005">5</figref>, a locking linkage 22 coupled to the actuator 15 and the yielding member 19 retains the opposing faces 17 held against the particular tissue of the patient 11 therebetween with the force from the yielding member 19 to achieve predetermined forces of compression. <figref idref="f0003">Figures 3</figref>, <figref idref="f0004">4</figref> and <figref idref="f0005">5</figref> show different levels of compression, i.e. no force, partial compression and full compression. This is achieved with the catch 22a and notches 22b as shown but any form of stepped latching arrangement that would hold the actuator 15 in a preset position is acceptable. Stepped latching positions on the actuator 15 permit the user to selectively set the locking linkage 22 and the yielding member 19 establishing the force for the particular vascular tissue sealed to retain the predetermined force in accord with the particular vascular tissue being sealed. The stepped latching positions are associated with different particular vascular tissue including arteries and veins and optionally mesentary if desired. For example, arteries will require a greater closure force than veins. It has been found that a closure force of greater than 1500 grams is effective for sealing arteries. A closure force of less than 500 grams is effective for sealing veins.

0037An active electrode 23 is carried on one of the pair of end effectors 16 in <figref idref="f0001">Figure 1</figref> but could be both of the end effectors 16. A return electrode 24 is in contact with the tissue of the patient 11. An electrosurgical energy supply 25 connects across the active electrode 23 of the pair of end effectors 16 and the return electrode 24. The electrosurgical energy supply 25 delivers electrosurgery between and across the active electrode 23 and the return electrode 24 when the particular tissue of the patient 11 is held by the pair of end effectors 16. The electrosurgical energy supply 25 includes an electrosurgical generator 26.

0038A feedback circuit 27 is in the electrosurgical generator 26. The feedback circuit 27 is in circuit with the active electrode 23 and the return electrode 24 and is responsive to the parameters indicative of energy delivery through the particular tissue of the patient 11 interposed between the active electrode 23 and the return electrode 24.

0039A temperature sensor 28 in <figref idref="f0002">Figure 2</figref> is connected to the feedback circuit 27 is carried on one of the opposed faces 17 and responds to the parameter of temperature of the particular tissue of the patient 11 between the pair of end effectors 16 during delivery of electrosurgical energy. An impedance monitor 29 in the feedback circuit 27 is electrically hooked up to the electrosurgical generator 26. The impedance monitor 29 responds to the parameter of the impedance of the particular tissue of the patient 11 between the active electrode 23 and return electrode 24 during delivery of electrosurgical energy.

0040A control 30 in <figref idref="f0001">Figure 1</figref> associated with the electrosurgical energy supply 25 applies electrosurgical energy to the held particular tissue of the patient 11 in response to the application of the predetermined force for the sealing the particular tissue between the pair of end effectors 16.

0041The return electrode 24 is alternatively shown in <figref idref="f0001">Figure 1</figref> on one of the pair of end effectors 16 opposite the active electrode 23. The return electrode 24 when on the one of the pair of end effectors 16 that carries the active electrode has an electrical insulator is disposed between the active electrode and the return electrode shown in <figref idref="f0003">Figure 3</figref>. The return electrode is specifically a pad connected to the tissue of the patient 11 in shown <figref idref="f0001">Figure 1</figref>.

0042The yielding member 19 can be a hydraulic coupling best shown in <figref idref="f0006">Figure 6</figref> as part of the lost motion connection between 18 and is located between the pair of end effectors 16 at the patient end 14 and the actuator 15 at the user end 13. The hydraulic coupling is preferably located near the actuator 15 at the user end 13 but can be anywhere. The hydraulic coupling can include piston 31 attached to elongate transfer rod 21. Fluid is compressed and metered by valve 33 to a floating plug 34 which is loaded by a spring 35 thus the compressive nature of fluid is primarily used to add the resilient bias.

0043The yielding member 19 could alternatively be a slip clutch 36 within the lost motion connection 18 located between the pair of end effectors 16 at the patient end 14 and the actuator 15 at the user end 13 as shown in <figref idref="f0006">Figure 7</figref>. The slip clutch 36 is most preferably located near the actuator 15 at the user end but could be elsewhere.

0044The slip clutch 36 in <figref idref="f0006">Figure 7</figref> is connected to elongate transfer rod 21 and includes a wheel 37 journalled to rotated when the rod 21 reciprocates. There is a brake band 38 pivotally mounted at 39 to be rotated against the wheel 37. The function connection between the wheel 37 and the brake band 38 acts as the yielding member 19 in this slip clutch 36. Although a spring 40 is shown the yielding is primarily the friction load of the brake.

0045The pair of end effectors 16 have opposing faces each of an equal and preset area. The opposing faces clamp the particular tissue of the patient 11 therebetween as seen in <figref idref="f0001">Figure 1</figref> with the force from the yielding member 19 so that a preferred pressure is applied to the particular tissue.

0046A method allows a user to clamp and apply force and electrosurgical energy to seal and/or join particular vascular tissue of a patient 11 with the clamping force mechanism 10 of the instrument hereinbefore described. The steps of the method including transferring user manipulation of the actuator 15 to the pair of end effectors 16 with the lost motion connection 18, maintaining a predetermined clamping force application during sealing and/or joining the particular tissue of the patient 11 between the pair of end effectors 16 with the lost motion connection 18 and applying electrosurgical energy for sealing and/or joining the held particular tissue of the patient 11 in response to the clamping thereof between the pair of end effectors 16 with the control associated with the electrosurgical energy supply 25.

0047The method step of applying electrosurgical energy includes responding to the parameter of the temperature of the particular tissue of the patient 11 between the pair of end effectors 16 during delivery of electrosurgical energy with the feedback circuit 27 including the temperature sensor 28 carried on one of the opposed faces 17.

0048The method step of applying electrosurgical energy includes responding to the impedance of the particular tissue of the patient 11 between the active electrode and return electrode during delivery of electrosurgical energy with the impedance monitor 29.

0049The method step of maintaining the predetermined clamping force application during sealing and/or joining of the particular tissue of the patient 11 by shifting of the yielding member 19 in the loss motion connection 18 with the actuator 15 so the opposing faces clamp the particular tissue of the patient 11 therebetween with force from the yielding member 19.

0050The method step of shifting with the actuator 15 secures the predetermined clamping force application during sealing of the particular tissue of the patient 11 by the resilient bias of the yielding member 19 and by including the step of urging with the spring 20.

0051The method step of shifting with the actuator 15 secures the predetermined clamping force application during sealing of the particular tissue of the patient 11 by the yielding member 19 and by including the step of moving the pair of end effectors 16 between their open position for receiving the particular tissue of the patient 11 to the clamping position with the elongated transfer rod 21 located between the spring 20 near the actuator 15 and the pair of end effectors 16 at the patient end 14.

0052The method step of shifting with the actuator 15 secures the predetermined clamping force application during sealing of the particular tissue of the patient 11 by the resilient bias of the yielding member 19 and by including the step of urging with the hydraulic coupling as part thereof.

0053The method step of shifting with the actuator 15 secures the predetermined clamping force application during sealing of the particular tissue of the patient 11 by the resilient bias of the yielding member 19 and by including the step of urging with the slip clutch 36 as part thereof.

0054The method step of maintaining the predetermined clamping force application during sealing of the particular tissue of the patient 11 and by the step of using the force from the yielding member 19 so that pressure is applied to the particular tissue.