Surgical devices and methods of use thereof
Contents
1. 10 be configured to fit with the diameter of bore 130 to form a slip fit in which case adhesive or another bonding agent will be employed between cylindrical portion 128 and housing outer portion 112 to provide a secure connection or a press inter ference fit which would not require the use of a separate bonding agent Inaddition to the above as best shown in FIG 11 proximal cylindrical portion 128 of housing inner portion 116 is pro vided with two opposing flat surfaces 132a 1325 formed thereon to create two localized gaps 134a 1345 as shown in FIG 12 between housing outer portion 112 and housing inner portion 116 through which legs 136a 1365 of elec trodes 114a 1145 may extend to be connected with wire conductors 158a 1585 of insulated wires 160a 1605 Returning to FIG 11 legs 136a 1365 of electrodes 114a 1145 extend proximally from two semi circular shaped elec trode portions 138a 1385 located at the distal end of device 30a and having the same size and shape In this manner the current density exhibited by the electrodes relative to one another will be substantially uniform Also as shown the semi circular electrode portions are mirror images of each other and each comprises the shape of about half of a circle Electrodes 114a 1145 preferably comprise an electrically conductive metal which is also preferably non corrosive preferred material is stainless steel Other suitable metals include titanium gold s2. Ps High Medium Low Qe FIG 5 U S Patent Jul 10 2012 Sheet 5 of 15 US 8 216 233 B2 A N N N M c e US 8 216 233 B2 Sheet 6 of 15 Jul 10 2012 U S Patent 2 ord U S Patent Jul 10 2012 Sheet 7 of 15 US 8 216 233 B2 FIG 8 U S Patent Jul 10 2012 Sheet 8 of 15 US 8 216 233 B2 purus U S Patent Jul 10 2012 Sheet 9 of 15 US 8 216 233 B2 FEG IO U S Patent Jul 10 2012 Sheet 10 of 15 US 8 216 233 B2 pug SO 1 52 i50 158 Sb GO 160 b US 8 216 233 B2 Sheet 11 of 15 4 Oa Jul 10 2012 U S Patent aas T d 2 5 22222223 RES SS AS AAAS AA AA ASS SSAA ASI SS AAAS NANO 2 0 SSS AS 24 4 SSS ESSERE SSS SSS SESSASSESESEAESESEESEEAEAREAS Se EE ES 8 22 1586 E ELGG IL US 8 216 233 B2 Sheet 12 of 15 Jul 10 2012 U S Patent 4 uw 130 US 8 216 233 B2 Sheet 13 of 15 Jul 10 2012 U S Patent 0 t S pr lt lt LLL LLL
3. United States Patent US008216233B2 10 Patent No US 8 216 233 B2 McClurken et al 45 Date of Patent Jul 10 2012 54 SURGICAL DEVICES AND METHODS OF 6 053 937 A 4 2000 Edwards et al USE THEREOF 6 149 646 A 11 2000 West Jr et al 6 485 490 B2 11 2002 Wampler et al 6 575 968 6 2003 Eggers et al 75 Inventors Michael E McClurken Durham NH 6 602242 8 2003 Fung etal ouou 604 528 US Roger D Greeley Portsmouth 6 656 174 B1 12 2003 Hedge et al NH US Brian M Conley South Continued Berwick ME US COREE FOREIGN PATENT DOCUMENTS 73 Assignee Salient Surgical Technologies Inc Portsmouth NH US JP 2003079633 3 2003 Continued 5 Notice Subject to any disclaimer the term of this patent is extended or adjusted under 35 OTHER PUBLICATIONS U S C 154 b by 1118 days International Search Report and Written Opinion dated Aug 29 2008 21 Appl 0 issued in related International Patent Application No PCT USOS 057815 22 Filed Mar 21 2008 Continued 65 Prior Publication Data Primary Examiner Linda Dvorak US 2008 0234674 A1 Sep 25 2008 Assistant Examiner Khadijeh Vahdat VM 74 Attorney Agent or Firm Sterne Kessler Gold Related U S Application Data stein amp Fox PL L C 60 Provisional application No 60 896 768 filed on Mar 23 2007 57 ABSTRACT The invention provides surgical devices and methods to treat 51 Int Cl tissue In one device em
4. The device according to claim 20 wherein the at least two fluid exits comprise a first fluid exit and a second fluid exit the fluid passage comprises a length from the first fluid exit to the second fluid exit and the fluid passage is linear along its length 23 The device according to claim 1 wherein the fluid passage comprises a lumen of tubing 24 The device according to claim 1 wherein the fluid passage comprises at least one bore in a housing which secures the first semi circular shaped electrode and the second semi circular shaped electrode to the device 25 The device according to claim 24 wherein the at least one bore in the housing comprises a first bore in the housing and a second bore in the housing and the first bore and the second bore intersect and are perpen dicular to each other 26 The device according to claim 24 wherein the fluid passage comprises a T shaped bore in the housing 27 The device according to claim 1 wherein the shaft comprises a metal shaft 28 The device according to claim 1 wherein the shaft is angled 29 The device according to claim 1 wherein the electri cally insulative material is sandwiched between the first semi circular shaped electrode and the second semi circular shaped electrode 30 The device according to claim 29 wherein the electri cally insulative material extends within the shaft wherein the electrically insulative material defines a cen tral longitu
5. U S Patent Jul 10 2012 Sheet 14 of 15 US 8 216 233 B2 30 4 18 26 220 C 4 ZZZ U S Patent Jul 10 2012 Sheet 15 of 15 US 8 216 233 B2 EGS 220 2065 Fre 2 0 US 8 216 233 B2 1 SURGICAL DEVICES AND METHODS OF USE THEREOF CROSS REFERENCE TO RELATED APPLICATIONS The present application claims the benefit of the filing date of U S Provisional Application Ser No 60 896 768 filed Mar 23 2007 the teachings of which are incorporated herein by reference FIELD This invention relates to surgical devices systems and methods for use upon tissues of a human body during surgery particularly open surgery and minimally invasive surgery such as laparoscopic surgery BACKGROUND A dry tip electrosurgical device such as a Bovie pencil can cause the temperature of tissue being treated to rise signifi cantly higher than 100 Celsius resulting in tissue desicca tion tissue sticking to the electrodes tissue perforation char formation and smoke generation Furthermore certain surgical devices are too large to be used in confined surgical spaces and or are simply ineffective in treating tissue such as to inhibit blood loss More recently fluid assisted electrosurgical devices have been developed which use saline to inhibit undesirable effects such as tissue desiccation electrode sticking smoke produc tion and char forma
6. and more particularly a vertebral body of the vertebra Inanother embodiment the invention provides a method of treating tissue having a blood vessel during surgery with the method comprising pressing a portion of the blood vessel against a bone structure with a surgical device to provide a compressed portion ofthe blood vessel and heating the com pressed portion of the blood vessel with the surgical device sufficiently to occlude the blood vessel after the surgical device is removed from the blood vessel In another embodiment the invention provides an electri cally powered surgical device to be used during a surgical procedure with the device comprising an aperture formed in the device the aperture having a button therein to activate the device the aperture defined by a perimeter wall surrounding the button a narrow gap between the button and the perimeter wall the narrow gap open to a flow of fluid therein from the surgical procedure the fluid comprising blood and the button having at least one side closely adjacent the perimeter wall surrounding the button the at least one side of the button having at least one aperture formed therein to inhibit the button from adhering with the perimeter wall by the blood Itis understood that the specific features described in these embodiments can be rearranged among the various embodi ments to provide devices apparatus systems and methods that fall within the scope of this disclosure B
7. 40 preferably comprising a printed circuit board which receives the inputs into electrosurgical unit 14 The user selected input values for RF power fluid flow rate and priming are then conveyed via corresponding input sig nals 41 to a main module 43 which preferably comprises a printed circuit board including a computer chip 45 a radio frequency generator 47 and a pump controller 48 As shown display panel module 40 and main module 43 as well as other components receive power from a power supply module 49 which also comprises a printed circuit board Computer chip 45 preferably comprises a micro processor unit a memory and an input output control unit In this manner the functional relationships between the radio fre quency power level and the flow of the fluid may be stored in the memory of the computer chip 45 While the functional relationships may be stored in the form of the foregoing equations they may also be stored as numerical data points as part of a database look up table As shown the input signals 41 are received and processed by computer chip 45 More specifically for example from the input signal received corresponding to the fluid flow rate setting of either Q Q or the computer chip 45 may first determine which ofthe above equations to apply After deter mining which equation to apply computer chip 45 may then apply the relationship to determine the output for flow of the fluid from the pump 32 based on
8. Using a New Monopolar Device 2005 0090816 1 8 4 2005 McClurken et al Gastrointestinal Endoscopy Jan 2004 vol 59 No 1 p 107 112 2005 0154386 AI 7 2005 West et al 606 41 Palanker et al Electrosurgery with Cellular Precision IEEE Trans 2005 0288665 Al 12 2005 Woloszko ti Bi dical Engi Feb 2008 1 55 No 2 2006 0052776 Al 3 2006 Desinger et al 0 2006 0106375 Al 5 2006 Werneth et al 838 841 i 2006 0149225 AI 7 2006 McClurken McCauley Genard Understanding Electrosurgery 55 049 2007 0027449 1 2 2007 Godara et al 606 41 001 Rev 2 2010 16 pages Bovie Medical Corporation Clearwater 2007 0270791 1 11 2007 Wang etal 606 41 FL United States 2008 0033421 1 2 2008 Davis et al 2008 0221567 A1 9 2008 Sixto et al cited by examiner US 8 216 233 B2 Sheet 1 of 15 Jul 10 2012 U S Patent FIG 1 US 8 216 233 B2 aes P 5 4 PPPoE 92 925 99 9 ve E 4 E 225525555555 I 1 7 23 3 LEMMA 2032036525 222 Le 22 B 2 Sue g 3 1 2 22 qmm 2 CE 2 H 7 1 Lo i 1 2 2 0 E wu dE VE MEME 2 2 2 2 92772727020072000000000000 22 21 gt 25 HOA M
9. by the low impedance ramp Above an impedance Z of 250 ohms the output power will also decrease as shown by the high impedance ramp Electrosurgical unit 14 has also been configured such that the pump speed and therefore the throughput of fluid expelled by the pump is predetermined based on two input variables the RF power setting and the fluid flow rate setting In FIG 5 there is shown a relationship of fluid flow rate Q in units of cubic centimeters per minute cc min on the Y axis and the RF power setting P in units of watts the X axis The relationship has been engineered to inhibit undesirable effects such as tissue desiccation electrode sticking smoke production and char formation while at the same time pro viding a fluid flow rate Q at a corresponding RF power setting which is not so great as to provide too much fluid and associated electrical dispersion and cooling at the electrode tissue interface While not being bound to a particular theory a more detailed discussion on how the fluid flow rate interacts with the radio frequency power modes of heat transfer from the tissue fractional boiling of the fluid and various control strategies may be found in U S Publication No 2001 0032002 published Oct 18 2001 and assigned to the assignee of the present invention and hereby incorporated by reference in its entirety to the extent it is consistent As shown electrosurgical unit 14 has been configured to incre
10. it is desirable to prime device 30 with fluid 24 Priming is desirable to inhibit RF power activation without the presence of fluid 24 A priming switch 54 is usedto initiate priming of device 30 with fluid 24 Pushing switch 54 once initiates operation of pump 32 for a predetermined time period to prime device 30 After the time period is complete the pump 32 shuts off automatically When priming of device 30 is initiated a priming display 56 comprising an indicator light illuminates during the priming cycle On the front panel the bipolar activation display 74 illumi nates when RF power 18 activated from the electrosurgical unit 14 either via a hand switch 162 on device 30 as shown in FIG 1 or a footswitch not shown A pullout drawer 76 is located under the electrosurgical unit 14 where the user of electrosurgical unit 14 may find a short form of the user s manual FIG 3 shows the rear panel of electrosurgical unit 14 rear panel of the electrosurgical unit 14 includes a speaker 60 and a volume control knob 62 to adjust the volume ofthe tone that will sound when the RF power is activated RF power activation tone The volume ofthe RF power activation tone 18 increased by turning the knob clockwise and decreased by turning the knob counterclockwise However the electrosur gical unit 14 prevents this tone from being completely silenced Rear panel of electrosurgical unit 14 also includes a power cord receptacle 64 used to co
11. semi circular shaped electrode and the second semi circular shaped electrode are mirror images of each other 4 The device according to claim 1 wherein the first semi circular shaped electrode has a first electrode semi circular shaped perimeter and the second semi circular shaped electrode has a second electrode semi circular shaped perimeter 5 he device according to claim 4 wherein the first electrode semi circular shaped perimeter is exposed and the second electrode semi circular shaped perimeter is exposed 6 The device according to claim 4 wherein the distal end of the device has a circumference and the first electrode semi circular shaped perimeter and the second electrode semi circular shaped perimeter each extend around a portion of the circumference 7 device according to claim 4 wherein the first electrode semi circular shaped perimeter is cov ered by an electrical insulation and the second electrode semi circular shaped perimeter is covered by an electrical insulation 8 The device according to claim 4 wherein a housing secures the first semi circular shaped electrode and the second semi circular shaped electrode to the device and US 8 216 233 B2 17 a portion of the housing covers the first electrode semi circular shaped perimeter and the second electrode semi circular shaped perimeter 9 The device according to claim 8 wherein the portion ofthe housing covering the first electro
12. shown by electrical field lines 206 is provided to tissue 200 at tissue surface 202 and below tissue surface 202 into tissue 200 through fluid 24 Electrodes 114a 1145 are connected to electrosurgical unit 14 to provide RF energy power and form an alternating cur rent electrical field in tissue 200 In the presence ofalternating current the electrodes 114a 1145 alternate polarity between positive and negative charges with current flow from the positive to negative charge Without being bound to a particu lar theory heating of the tissue 18 performed by electrical resistance heating That is the temperature of the tissue increases as a result of electric current flow through the tissue with the electrical energy being absorbed from the voltage and transformed into thermal energy i e heat via acceler ated movement of ions as a function of the tissue s electrical resistance Heating the compressed portion of blood vessel 220 with device 30a is sufficient to at least partially occlude blood vessel 220 to inhibit blood flow through the vessel 220 after device 30a is removed from vessel 220 Here this is per formed by heating vessel 220 sufficiently to shrink the col lagen in vessel 220 thereby shrinking the vessel 220 and the lumen 222 of vessel 220 This is also performed by apply sufficient heating and pressure to the compressed portion of vessel 220 to weld the opposing internal surfaces 224 and 226 of the lumen 222 together here
13. site making visibility more difficult and prolonging the procedure A method of the present invention may be used to seal such vertebral blood vessels against blood loss before the vessels are cut rupture or are otherwise severed This method involves pressing a portion of the blood vessel against a supporting spine structure with a surgical device such as the devices of the present invention to provide a compressed portion of the blood vessel and heating the compressed por tion ofthe blood vessel with the surgical device sufficiently to occlude the blood vessel e g by shrinking the vessel and the Iumen by shrinkage ofthe collagen in the vessel and or weld ing the opposite internal surfaces of the lumen together by collagen welding to inhibit a blood flow through the vessel after the surgical device is removed from the blood vessel The supporting spine structure against which the blood vessel is compressed comprises one or more vertebra of the spine and may further comprise the vertebral body of the vertebra The vertebra may comprise one of the cervical ver tebrae thoracic vertebrae or lumbar vertebrae In addition to the vertebrae the support structure may also comprise a spi nal ligament such as the anterior longitudinal ligament or the posterior longitudinal ligament or an intervertebral disc Depending on the type of procedure the supporting spine structure may further comprise an anterior side of the verte bral body of the
14. support member 8 and thereafter secured in position with a set screw On the top of the fluid source carrying pole 16 is a cross support 18 provided with loops 20 at the ends thereof to provide a hook for carrying fluid source 22 20 25 30 40 45 55 65 4 Returning to FIG 1 fluid source 22 comprises a bag of fluid from which the fluid 24 flows through a drip chamber 26 afterthe bag is penetrated with a spike located at the end ofthe drip chamber 26 Thereafter fluid 24 flows through flexible delivery tubing 28 to handheld electrosurgical device 30 Preferably the fluid delivery tubing 28 is made from a poly mer material As shown in FIG 1 the fluid delivery tubing 28 passes through pump 32 As shown pump 32 comprises a peristaltic pump and more specifically a rotary peristaltic pump With a rotary peristaltic pump a portion of the delivery tubing 28 is loaded into the pump head by raising and lowering the pump head in a known manner As best shown in FIG 6 fluid 24 is conveyed within the delivery tubing 28 by waves of contrac tion placed externally on the tubing 28 which are produced mechanically typically by rotating pinch rollers 57 which rotate on a drive shaft 55 and intermittently compress the tubing 28 against an anvil support 58 Alternatively pump 32 may comprise a linear peristaltic pump With a linear peri staltic pump fluid 24 is conveyed within the delivery tubing 28 by waves of contraction placed
15. the selected radio frequency power level Having determined this output the computer chip 45 then sends output signals 51 and 53 corresponding to the selected radio frequency power level and calculated out put for flow of the fluid from the pump 32 to the radio frequency generator 47 and pump controller 48 respectively Thereafter the pump controller 48 controls the speed of the pump drive shaft 55 by controlling the input voltage 59 to the pump motor 61 which rotates the drive shaft 55 More detailed drawings of exemplary electrosurgical unit 14 may be found in U S Publication No 2006 0149225 published Jul 6 2006 and assigned to the assignee of the present invention and hereby incorporated by reference in its entirety to the extent it is consistent Electrosurgical unit 14 can include a delay mechanism such as a timer to automatically keep the fluid flow on for several seconds after the RF power is deactivated to provide a post treatment cooling Electrosurgical unit 14 can also include a delay mechanism such as a timer to automatically turn on the fluid flow up to several seconds before the power is activated to inhibit the possibility of undesirable effects as tissue desiccation electrode sticking char forma tion and smoke production Electrosurgical unit 14 is particularly configured for use with bipolar devices With a bipolar device an alternating current is created between the first and second electrical poles ofthe
16. vertebra or a lateral anterior side of the vertebral body of the vertebra which would be encountered during an anterior approach For a posterior approach the supporting spine structure may further comprise a posterior side ofthe vertebral body ofthe vertebra or a lateral posterior side of the vertebral body of the vertebrae The anterior or posterior approach may be part of an endoscopic spine sur gery laparoscopic spine surgery or open spine surgery Due to the rigidity of the vertebra and stability of the vertebrae the blood vessel may be pressed against the verte bra without the vertebra deforming In this manner the blood vessel may be compressed at which time the compressed 0 25 40 45 14 portion of the vessel may be heated sufficiently to occlude the blood vessel after the surgical device is removed from the blood vessel FIG 17 shows how the distal portion 106 of device 30a and similarly for devices 305 304 may be oriented for use with the longitudinal axis of shaft 102 vertically oriented and the distal end of device 30a facing a tissue treatment site In other embodiments device 30a may be used with the longi tudinal axis of shaft 102 horizontally oriented or at any orientation between vertical and horizontal FIG 17 shows device 30a and tissue 200 prior to treatment thereof As shown tissue 200 comprises a blood vessel 220 and more specifically an epidural vein Underlying blood vessel 220 is a lig
17. with the lower contact thus closing the hand switch control circuit The presence of the closed control circuit is then sensed by electrosurgical unit 14 which then provides power to the electrodes 1140 8 When a depression force is removed from the upper con tact the contact returns to its undepressed domed position as a result of its resiliency or elastic memory thus returning US 8 216 233 B2 9 button 164 to its undepressed position and reopening the hand control circuit The presence of the open control circuit is then sensed by electrosurgical unit 14 which then stops providing power to electrodes 114a 1145 More detailed drawings and an explanation of the operation of switch assembly 162 may be found in U S Publication No 2005 0090816 published Apr 28 2005 and assigned to the assignee of the present invention and hereby incorporated by reference in its entirety to the extent it is consistent During use of device 30a blood and coagulum may deposit in a narrow gap 170 between button 164 and handle 104 As best shown in FIG 10 button 164 is located in aperture 166 of handle 104 which is defined by a perimeter wall 168 As shown button 164 includes a plurality of apertures 163 in the sides thereof Apertures 163 reduce the surface area of the side walls 165 of button 164 adjacent to the perimeter wall 168 of handle portions 104a 1045 Consequently due to the reduced surface area of the side walls 165 of button 164 button
18. 164 is less apt to adhere and stick to handle portions 104a 1045 by virtue of the blood and coagulum when the depression force is removed from button 164 As best shown in FIG 11 device 30a has a disc shaped distal end comprising two bipolar electrodes 114a 1145 An insulator housing assembly comprising housing outer portion 112 and housing inner portion 116 secures the electrodes 114a 114 to device 30a Housing outer portion 112 and housing inner portion 116 comprise an electrically insulative material preferably a polymer and more preferably a fluori nated polymer such as polytetrafluoroethylene PTFE In addition to functioning as an electrical insulator polytet rafluoroethylene is preferred because it is hydrophobic and thus inhibits fluids present during surgery from settling thereon provides good arc resistance and provides a low coefficient of friction for reduced tissue sticking As shown in FIG 12 housing outer portion 112 electrically insulates electrodes 114a 1145 from metal shaft 102 As shown in FIGS 11 and 12 housing outer portion 112 com prises a proximal cylindrical portion 118 and a distal cylin drical portion 120 Proximal cylindrical portion 118 has a slightly small outer diameter than distal cylindrical portion 120 which creates a rim 122 there between For assembly proximal cylindrical portion 118 provides a connector por tion for connecting housing outer portion 112 to shaft 102 As shown in FIG 12 th
19. Clurken et al 2009 0156981 6 2009 Hay etat 2009 0177192 1 7 2009 Rioux et al 6 960 200 B2 11 2005 Shapeton et al 2009 0270856 A1 10 2009 Saadat etal 6 979 328 B2 12 2005 Baerveldt et al 7 104990 B2 9 2006 Jenki al 2010 0036371 1 2 2010 Park et al 929 enkins ctal 2010 0100095 A1 4 2010 McClurken et al 7 112 199 B2 9 2006 Cosmescu 2010 0114095 1 5 2010 Janssen et al 7 147 637 B2 12 2006 Goble 7175644 B2 2 2007 t al 2010 0160906 A1 6 2010 Jarrard ae QODEL etd 2010 0204560 Al 8 2010 Salahieh et al 7 455 660 2 11 2008 Swanson 7571729 B2 8 2009 Saadat et al 2010 0241178 Al 9 2010 Tilson et al TOTO E Sugi 2010 0312259 Al 12 2010 Houser et al 7811282 B2 10 2010 MeClurken 2010 0331883 Al 12 2010 Schmitz et al 7 819 861 B2 10 2010 Auge II et al FOREIGN PATENT DOCUMENTS 7 819 864 B2 10 2010 Morgan et al 2001 0001314 1 5 2001 Davison et al 606 4 WO 02060523 8 2002 2001 0014806 1 8 2001 Ellman et al 2 606 45 2002 0049438 1 4 2002 Sharkey etal 2 606 41 OTHER PUBLICATIONS 2002 0077626 Al 6 2002 Ellman et al 2 606 41 2002 0198520 Al 12 2002 Coen etal 606 41 European Search Report dated Mar 1 2010 issued in related Euro 2004 0243121 1 12 2004 Lee et al pean Patent Application No 08744175 4 2305 2005 0059966 1 3 2005 McClurken et al Salameh et al Animal Model Study Clarify and Investigate 2005 0070894 1 3 2005 McClurken Endoscopic Tissue Coagulation by
20. ENS 5 5 7 2 22 4 3 2 SNS EE 2 4 LCC AAALAC LALLA LLL LLL LLL LL 2 2 m getto pepe BE 2 gie 2 2 0 475 7 A E un 3 2 4 53 RORIS 1 5 23 11 P dup guerre 2 ins 7 2 2 E v To venen Pod od QU t 2i it po wd iai 4 5 54 Ab 22222327 CT id LL i 2 RI TUO ad 0 3 H 28 8877 E f 4 PM i 1 p 7 1 em 1 e 1 gt 1237 2 i 5 2 27 22 pi LM 4 22 5 2 1 1 2 D 4 7 t 21 22 un 2 2 1 1 2 ASA AMA i X Y M 5 Jul 10 2012 6 13 U S Patent U S Patent Jul 10 2012 Sheet 3 of 15 US 8 216 233 B2 14 FIG U S Patent 250 200 Power Watts Saline Flow Rate cc min 150 100 50 Jul 10 2012 Sheet 4 of 15 US 8 216 233 B2 Tp Bipolar Pow er 200 Watt Setting Bipolar Pow er 0100 Watt Setting 0 100 200 300 400 500 600 700 800 900 1000 Load Ohms Z FIG 4 40 60 80 100 120 140 160 180 200 Power Setting Watts
21. RIEF DESCRIPTION OF THE DRAWINGS FIG 11sa front view of one embodiment 01 8 system of the present invention having an electrosurgical unit in combina tion with a fluid source and handheld electrosurgical device FIG 2 isa front perspective view of the electrosurgical unit of FIG 1 FIG 3 is a rear view of the electrosurgical unit of FIG 1 FIG 4 is a graph of the RF power output P versus imped ance Z for the electrosurgical unit of FIG 1 FIG 5 is graph showing three relationships of fluid flow rate Q of saline at high medium Q and low in units of cubic centimeters per minute cc min on the Y axis and the RF power setting P in units of watts on the X axis FIG 6 18 a block diagram showing one embodiment of how the electrosurgical unit processes the inputs of RF power setting P and the fluid flow rate setting either Q Q or to control the pump speed FIG 7 is an isometric view of an assembly of an exemplary electrosurgical device according to the present invention FIG 8 is an isometric view of the inner components of the handle with the handle removed FIG 9 is a side view of a handle portion of the device of FIG 7 assembled with various components US 8 216 233 B2 3 FIG 10 is a close up side view of a button and handle portion of the device of FIG 7 assembled with various com ponents FIG 11 is an exploded view ofa distal portion ofthe device of FIG 7 FIG 12 is a close up longit
22. ament 230 and more specifically a longi tudinal ligament of the spine Underlying ligament 230 is a vertebra 232 and more specifically a vertebral body of the vertebra 232 FIG 18 shows device 30a applied to tissue 200 with suf ficient force and pressure applied to device 30a by the user thereof to press a portion of the blood vessel 220 against the supporting spine structure here ligament 230 and vertebra 232 to provide a compressed portion of the blood vessel 220 In certain embodiments device 30a may include a feedback mechanism such as a force or pressure gauge which alerts the user of the device when sufficient force pressure is applied to vessel 220 In other embodiments the feedback mechanism may comprise a light which activates As shown electrodes 114a 114b of device 30a are spaced adjacent tissue surface 202 of tissue 200 by the width of distal spacer portion 126 of housing inner portion 116 FIG 19 shows device 30a in use with fluid 24 expelled from holes 146a 1465 that flows distally to electrodes 114a 1145 to provide a localized fluid coupling 204 between sur face 202 of tissue 200 and electrodes 114a 1142 Preferably fluid 24 couples between the electrodes 114a 1145 and the tissue 200 at both the perimeter 151a 1515 of electrodes 114a 1145 and flat semi circular shaped electrode portions 138a 1385 of the electrodes 114a 1145 located at the distal end of device 30a At the same time RF electrical energy power
23. ase the fluid flow rate Q linearly with an increasing RF power setting P for each of three fluid flow rate settings of low medium and high corresponding Qw and respectively Conversely electrosurgical unit 14 has been configured to decrease the fluid flow rate Q linearly with a decrease RF power setting P for each of three fluid flow rate settings of low medium and high corresponding to Q Qay and Qy respectively As shown Qz Q and can be expressed as a function of the RF power setting by chang ing exemplary proportionality constants as follows 01 0 1286 Qg 0 1571xPs FIG 6 shows an exemplary block diagram of how electro surgical unit 14 processes the inputs of RF power setting P and the fluid flow rate setting either Q4 or Qy to control the pump speed and therefore the throughput of fluid expelled by the pump 32 As shown user selected input values for the RF power setting and the fluid flow rate setting of either low medium and high corresponding to Q Q and as well as activating the priming function are entered into electrosurgical unit 14 by pushing corresponding switches for these parameters positioned on the front panel of the electrosurgical unit 14 shown in FIG 6 the RF power setting switches 46a 465 the flow rate setting switches 52a 525 52 and the US 8 216 233 B2 7 priming switch 54 are all preferably part of a display panel module
24. bodiment the invention comprises a A61B 18 14 2006 01 bipolar electrosurgical device to treat tissue in a presence of 52 U S DE 606 48 radio frequency power and a fluid provided simultaneously 58 Field of Classification Search 606 41 52 from a distal portion ofthe device with the device comprising See application file for complete search history a disc shaped distal end In one method embodiment the invention comprises a method of treating tissue having a 56 References Cited blood vessel during spine surgery with the method compris ing pressing a portion ofthe blood vessel against a supporting U S PATENT DOCUMENTS spine structure with a surgical device to provide a compressed 4 936 281 A 6 1990 Stasz portion of the blood vessel and heating the compressed por DU UA x 311992 Rydell tion ofthe blood vessel with the surgical device sufficiently to 22 dd D 606 49 inhibit a blood flow through the vessel after the surgical 395 illings et al E 5 460 629 A 10 1995 Shlain et al device is removed from the blood vessel 5 484 435 A 1 1996 Fleenor et al 6 004 269 A 12 1999 Crowley et al 41 Claims 15 Drawing Sheets 30 Wa Tia 13 Ba juga la 1360 136 2 16 132 2k 128 libb 130 120 122 ng 152 150 1582 25 60 US 8 216 233 B2 Page2 U S PATENT DOCUMENTS 2009 0118732 A1 5 2009 Desinger 6 702 810 82 3 2004 Mc
25. by collagen welding The time to shrink tissue containing Type I collagen such as blood vessels is generally dependent on temperature For US 8 216 233 B2 15 example Type I collagen shrinks at an exposure time of about 0 01 seconds when exposed to a temperature of about 85 C at an exposure time of about 1 second when exposed to a temperature of about 75 C at an exposure time of about 10 second when exposed to a temperature of about 70 C and at an exposure time of about 15 minutes when exposed to a temperature of about 65 C An exemplary target tempera ture time for tissue heating is about 75 C with second Stated another way for expediency the tissue should be heated sufficiently to shrink the collagen in the range between and including about 1 second to 10 seconds after RF activa tion Fluid 24 in addition to providing an electrical coupling between the device 30a and tissue 200 cools and lubricates surface 202 of tissue 200 to inhibit electrodes 114a 1145 from sticking to tissue 200 Depending on the amount of fluid at the distal end of device 30a and the tissue treatment site the fluid coupling 204 may comprise a single coupling which encompasses the distal end of the device 30a or a plurality of discrete couplings which are located on each side of the device closest to holes 146a 1465 The fluid coupling for device 30a may also comprise a conductive fluid bridge between electrodes 114a 1145 which rests on s
26. ce according to claim 39 wherein the housing defines at least two intersecting channels therein 41 The device according to claim 39 wherein the fluid passage comprises a T shaped bore in the housing
27. changeable as suitable and not exclusive From the specification it should be clear that any use of the terms distal and proximal are made in reference from the user of the device and not the patient The inventions disclosed herein provide devices systems and methods for treating tissue during a surgical procedure These inventions are particularly useful for procedures where it is desirable to shrink coagulate and seal tissue against blood loss for example by shrinking lumens of blood vessels e g veins arteries The invention will now be discussed with reference to the figures with FIG 1 showing a front view of one embodiment ofa system ofthe present invention having an electrosurgical unit 14 in combination with a fluid source 22 and a handheld electrosurgical device 30 FIG 1 shows a movable cart 2 having a chassis 4 which is provided with four wheels 6 for easy transportation The chassis 4 carries a vertical support member 8 comprising a hollow cylindrical post to which a storage basket 10 may be fastened and used to store the electrosurgical unit s user manual as well as additional unused devices Furthermore the support member 8 carries a platform 12 comprising a pedestal table to provide a flat stable surface for location of the electrosurgical unit 14 As shown cart 2 further comprises a fluid source carrying pole 16 having a height which may be adjusted by sliding the carrying pole 16 up and down within the
28. communication lumen 29 of fluid delivery tubing 28 In this manner bore 140 and bore 144 provide a T shaped fluid flow passage for fluid 24 provided from fluid delivery tubing 28 and 150 As shown in FIG 11 in order to have fluid from the fluid passage provided by bore 144 exit device 30a cylindrical portion 120 ofhousing outer portion 112 is provided with two through holes 146a 1466 which align with bore 144 and provide fluid exits for fluid As shown bore 144 extends through housing inner portion 116 parallel to distal spacer portion 126 As best shown in FIG 11 holes 146a 1465 are provided in the electrically insulative material used for housing outer portion 112 and are located on the distal portion of device 30a proximal to the distal end of the device In this manner holes 146a 1465 are configured to inhibit clogging during use of US 8 216 233 B2 11 the device 30a In other words since housing outer portion 112 is not electrically conductive and does not function as an electrode tissue and blood coagulum are less apt to stick to housing outer portion 112 Also since holes 146a 1465 are located on the distal portion of device 30a proximal to the distal end of the device holes 146a 1465 are less apt to be exposed directly to the bloody field generally located at the distal end of device 30a In the event holes 146a 1465 and bore 144 become clogged holes 146a 1465 and bore 144 may be unclogged and cleaned by insertin
29. de semi circular shaped perimeter and the second electrode semi circular shaped perimeter comprises a ring shaped portion of the housing 10 The device according to claim 1 wherein the distal portion of the device comprises the first semi circular shaped electrode the second semi circular shaped electrode and a housing which secures the first semi circular shaped electrode and the second semi circular shaped electrode to the device 11 The device according to claim 10 wherein the housing comprises a second electrically insulative material 12 The device according to claim 11 wherein the second electrically insulative material comprises a polymer material 13 The device according to claim 10 wherein the housing comprises a proximal cylindrical portion and the housing is connected to the shaft by fitting the proximal cylindrical portion of the housing within a lumen of the shaft 14 The device according to claim 1 wherein the at least one fluid exit is located proximal to the distal end of the device 15 The device according to claim 1 wherein the at least one fluid exit is provided by a housing which secures the first semi circular shaped electrode and the second semi circular shaped electrode to the device 16 The device according to claim 1 wherein the first semi circular shaped electrode comprises a first electrode first corner and a first electrode second corner and the at least one fluid exit is closest t
30. decrease in the radio frequency power level and a fluid flow selector which changes the functional relationship between the radio fre quency power level and the flow of the fluid In another embodiment the invention provides a bipolar electrosurgical device to treat tissue The device comprises a handle anda shaft extending distally from the handle with the shaft supporting the distal portion of the device in rigid rela tion to the handle The distal portion ofthe device terminates 20 25 30 35 40 45 50 55 60 65 2 at a distal end comprising a disc shaped distal end The disc shaped distal end comprises a first semi circular shaped elec trode and a second semi circular shaped electrode The device may further comprise a fluid delivery passage being connectable to a fluid source of fluid and at least one fluid exit in fluid communication with the fluid delivery passage Inanother embodiment the invention provides a method of treating tissue having a blood vessel during spine surgery with the method comprising pressing a portion of the blood vessel against a supporting spine structure with a surgical device to provide a compressed portion of the blood vessel and heating the compressed portion of the blood vessel with the surgical device sufficiently to occlude the blood vessel after the surgical device is removed from the blood vessel In certain embodiments the supporting spine structure com prises a vertebra
31. device An exemplary bipolar electrosurgical device of the present invention which may be used in conjunction with electrosurgical unit 14 of the present invention is shown at reference character 30a in FIG 7 While various electrosur gical devices of the present invention are described herein with reference to use with electrosurgical unit 14 it should be understood that the description of the combination is for purposes of illustrating the system of the invention Conse quently it should be understood that while the electrosurgical devices disclosed herein may be preferred for use with elec trosurgical unit 14 it may be plausible to use other electro surgical devices with electrosurgical unit 14 such as monopo lar devices or it may be plausible to use the electrosurgical devices disclosed herein with another electrosurgical unit other than electrosurgical unit 14 0 5 40 45 50 55 60 65 8 shown in FIG 7 exemplary bipolar electrosurgical device 30a comprises a single stationary arm 100 which comprises a rigid self supporting hollow shaft 102 As shown shaft 102 is preferably angled to provide better view ing of the distal tip portion 106 of device 30a during use thereof Shaft 102 preferably comprises metal tubing and more preferably thick walled hypodermic stainless steel tub ing In this manner shaft 102 has sufficient rigidity to main tain its form during use of device 30a without kinkin
32. dinal bore therein and wherein the fluid delivery passage includes the central longitudinal bore 31 The device according to claim 30 wherein the electri cally insulative material defines a side bore intersecting the longitudinal bore and wherein the transverse side bore is configured to fluidly communicate with the at least one fluid exit 32 The device according to claim 1 wherein the first semi circular shaped electrode and the second semi circular shaped electrode each comprises an electrode leg extending within the shaft 33 The device according to claim 32 further comprising afirst wire coupled to a proximal end ofthe electrode leg of the first semi circular shaped electrode and a second wire coupled to a proximal end of the electrode leg of the second semi circular shaped electrode 34 The device according to claim 32 wherein an axial cross sectional area 01 8 distal portion ofthe first semi circu lar shaped electrode is greater than an axial cross sectional area ofthe leg ofthe first semi circular shaped electrode and wherein an axial cross sectional area of a distal portion ofthe second semi circular shaped electrode is greater than an axial cross sectional area of the leg of the second semi circular shaped electrode 35 A bipolar electrosurgical device to treat tissue in a presence of radio frequency power and a fluid provided from a distal portion of the device the device comprising a handle a shaft extendi
33. e desired hemostasis of the tissue More particularly the devices may be useful to shrink blood vessels either severed or unsevered during spine surgery such as blood vessels of the vertebral venous and or arterial systems during for example a discec tomy Intervertebral discs are flexible pads of fibrocartilaginous tissue tightly fixed between the vertebrae of the spine The discs comprise a flat circular capsule roughly an inch in diameter and about 0 25 inch thick made of a tough fibrous outer membrane called the annulus fibrosus surrounding an elastic core called the nucleus pulposus Under stress it is possible forthe nucleus pulposus to swell and herniate pushing through a weak spot in the annulus fibrosus membrane of the disc and into the spinal canal Consequently all or part of the nucleus pulposus material may protrude through the weak spot causing pressure against surrounding nerves which results in pain and immobility Where a damaged intervertebral disc must be removed from the patient as part ofa discectomy and subsequent fusion of vertebral bodies of the superior and inferior vertebrae the devices of the present invention may be particularly useful to shrink and seal blood vessels of the vertebral venous and or arterial systems The vertebral venous system includes any of four intercon nected venous networks surrounding the vertebral column These are known as the anterior external vertebral venous plexus the sys
34. e outside diameter of proximal cylindri cal portion 118 is configured to extend into lumen 124 of shaft 102 and fit with the inside diameter of shaft 102 with rim 122 in contact with the distal end 110 of shaft 102 The outside diameter of proximal cylindrical portion 118 may be config ured to fit with the inside diameter of shaft 102 to form a slip fit in which case adhesive or another bonding agent will be employed between cylindrical portion 118 and shaft 102 to provide a secure connection or a press interference fit which would not require the use of a separate bonding agent As shown in FIGS 11 and 12 housing inner portion 116 electrically insulates electrodes 114a 1146 from one another by providing a spacer there between In particular housing inner portion 116 comprises a distal spacer portion 126 dis posed between electrodes 114a and 1145 For assembly housing inner portion 116 further comprises a proximal cylin drical portion 128 for connecting housing inner portion 116 to housing outer portion 112 As shown in FIG 12 the outside diameter of proximal cylindrical portion 128 is configured to extend into inner bore 130 of housing outer portion 112 and fit with the diameter of bore 130 with the distal cylindrical portion 120 of housing outer portion 112 providing a collar around housing inner portion 116 and electrodes 114a 1145 Theoutside diameter of proximal cylindrical portion 128 may 0 20 30 40 45 55
35. externally on the tubing 28 which are produced mechanically typically by a series of compression fingers or pads which sequentially squeeze the tubing 28 against a support Peristaltic pumps are generally preferred as the electro mechanical force mechanism here rollers driven by electric motor does not make contact the fluid 24 thus reducing the likelihood of inadvertent contami nation In a preferred embodiment the fluid 24 comprises saline and even more preferably normal physiologic saline Although the description herein may make reference to saline asthe fluid 24 other electrically conductive fluids can be used in accordance with the invention While a conductive fluid is preferred as will become more apparent with further reading of this specification fluid 24 may also comprise an electrically non conductive fluid The use non conductive fluid is less preferred than a conduc tive fluid however the use of a non conductive fluid still provides certain advantages over complete elimination of the fluid and the use of a dry electrode including for example reduced occurrence of tissue sticking to the electrode of device 30 and cooling of the electrode and or tissue There fore it 18 also within the scope of the invention to include the use ofa non conducting fluid such as for example deionized water As shown in FIG 1 electrosurgical device 30 is connected to electrosurgical unit 14 via a cable 34 which comprises a
36. for electrodes 114a 1145 and their surfaces and fluid 24 throughout the various embodiments should be such that the fluid 24 wets the surface ofthe electrodes 114a 1145 Contact angle 0 is a quantita tive measure ofthe wetting ofa solid by a liquid It is defined geometrically as the angle formed by a liquid at the three 20 25 30 35 40 45 50 55 60 65 12 phase boundary where a liquid gas and solid intersect In terms of the thermodynamics of the materials involved con tact angle 0 involves the interfacial free energies between the three phases given by the equation 8 971sy sr where and refer to the interfacial energies of the liquid vapor solid vapor and solid liquid interfaces respec tively If the contact angle 0 is less than 90 degrees the liquid is said to wet the solid If the contact angle is greater than 90 degrees the liquid is non wetting zero contact angle 0 represents complete wetting Thus preferably the contact angle is less than 90 degrees bipolar devices disclosed herein are particularly useful as non coaptive tissue sealers in providing hemostasis during surgery In other words grasping ofthe tissue is not necessary to shrink coagulate and seal tissue against blood loss for example by shrinking collagen and associated lumens of blood vessels e g arteries veins thereby inhibiting blood flow therethrough and therefrom to provided th
37. g a pin type structure into one of the holes and bore 144 and extending the pin completely through device 30a and exiting the pin from the other hole In this manner the matter clogging holes 146a 1465 and bore 144 may be pushed and removed there from by the pin Also as shown in FIG 11 holes 146a 1465 are located on opposing sides of device 30a Hole 146a is provided adjacent and closest to electrode 114a at corner 148a thereof and adjacent and closest to electrode 1144 at corner 1485 thereof Hole 1465 is provided adjacent and closest to electrode 114a at corner 149a thereof and adjacent and closest to electrode 1145 at corner 1495 thereof In this manner fluid may be provided to the locations of electrodes 114a 1145 and tissue expected to have the greatest need for the fluid for device 30a to function most properly i e the electrode corners and tissue adjacent thereto Also in this manner fluid from holes 146a 1465 may be provided to the semi circular shaped side perim eter 151a 1515 of electrodes 114a 1145 As shown in FIG 12 the semi circular shaped perimeter 151a 1515 of elec trodes 114a 1145 is exposed to tissue and extends circum ferentially around a substantial portion of the distal end of device 30a As shown the semi circular shaped perimeter 151a of electrode 114a extends from corner 148a to corner 149a of electrode 114a and the semi circular shaped perim eter 151 of electrode 1145 extends from corner 1485 to co
38. g or significant bending and support the distal portion 106 in rigid relation to a proximal handle 104 In other embodiments shaft 102 may be made of an electrical non conducting mate rial such as a polymer or composite material Proximal handle 104 comprises mating handle portions 104a 1045 Handle 104 is preferably made of a sterilizable rigid non conductive material such as a polymer Also handle 104 is preferably configured slender along with the rest of the device 30a to facilitate a user of device 30a to hold and manipulate device 30a like a pen type device Device 30a also comprises a flexible fluid delivery tubing 28 which is connectable to fluid source 22 preferably via a spike located at the end of drip chamber 26 as shown in FIG 1 anda cable 34 which is connectable to electrosurgical unit 14 which respectively provide fluid and RF power to distal portion 106 Inthis embodiment cable34 ofdevice 30a comprises three insulated wires 34a 342 34c as shown in FIG 8 connect able to electrosurgical unit 14 via three male plug connec tors 37 372 37c The plug connectors 37a 375 37c are each assembled with wires 34a 34b 346 and wire conductors 35a 35b 35c within a common plug housing 36 As best shown in FIG 8 which shows the inner components of the handle 104 with the handle 104 removed wire conductor 35a is directly connected preferably by welding to wire conductor 158a of insulated wire 160a which is d
39. gical unit 14 includes an RF power activation display 74 comprising an indicator light which illuminates when RF power is activated Switches 46a 465 may comprise membrane switches In addition to having a RF power setting display electro surgical unit 14 further includes a fluid flow rate setting dis play Flow rate setting display comprises three indicator lights 50a 505 and 50c with a first light 50a corresponding to a fluid flow rate setting of low a second light 505 correspond ing to a fluid flow rate setting of medium intermediate and a third light 50c corresponding to a flow rate setting of high Oneofthese three indicator lights will illuminate when a fluid flow rate setting is selected fluid flow selector comprising flow rate setting switches 52a 52b and 52c are used to select or switch the flow rate setting Three push switches are provided with the first switch 52a corresponding to a fluid flow rate setting of low the second switch 525 corresponding to a fluid flow rate setting of medium intermediate and the third switch 52c correspond ing to a flow rate setting of high Pushing one of these three switches selects the corresponding flow rate setting of either low medium intermediate or high The medium or inter mediate flow rate setting is automatically selected as the default setting if no setting is manually selected Switches 52a 52b and 52c may comprise membrane switches Before starting a surgical procedure
40. i circular shaped electrode to the shaft by fitting a proximal cylindrical portion of the housing within a Iumen of the shaft wherein the fluid exit is defined by the housing 39 A bipolar electrosurgical device to treat tissue in a presence of radio frequency power and a fluid provided from a distal portion of the device the device comprising 25 20 a handle a shaft extending distally from the handle the shaft sup porting the distal portion ofthe device in rigid relation to the handle the distal portion ofthe device terminating at a distal end of the device the distal end ofthe device comprising a disc shaped distal end having a bipolar electrode configura tion the disc shaped distal end comprising a first semi circular shaped electrode that serves as a first pole of the bipolar electrode configuration and a second semi circular shaped electrode that serves as a second pole of the bipolar electrode configuration a fluid delivery passage being connectable to a fluid source at least one fluid exit in fluid communication with the fluid delivery passage and configured to provide fluid to an exterior of the device at the distal portion of the device and a housing that secures the first semi circular shaped elec trode and the second semi circular shaped electrode to the shaft by fitting a proximal cylindrical portion of the housing within a lumen of the shaft wherein the fluid exit is defined by the housing 40 The devi
41. ilver and platinum As shown in FIG 12 the distal end of device 30a is planar flat and perpendicular to the longitudinal axis of shaft 102 In other embodiments as shown for example in FIG 13 the distal end of device 305 may be convex In still other embodi ments as shown for example in FIG 14 the distal end of device 30c may be concave Returning to FIG 12 housing inner portion 116 also includes a longitudinally oriented linear blind bore 140 and counter bore 142 centrally located within cylindrical portion 128 As shown the outside diameter of fluid delivery tubing 150 is configured to extend into counter bore 142 and fit with the diameter of counter bore 142 with the distal end of the tubing in contact with the bottom of the counter bore The outside diameter of fluid delivery tubing 150 may be config ured to fit with the diameter of counter bore 142 to form a press interference fit to provide a secure connection along with use of an adhesive or another bonding agent to provide a fluid tight seal between fluid delivery tubing 150 and housing inner portion 116 In addition to blind bore 140 and counterbore 142 housing inner portion 116 also includes a linear through bore 144 which perpendicularly intersects bore 140 at the distal end of bore 140 and extends through cylindrical portion 128 As shown bore 140 and bore 144 are in fluid communication with lumen 152 of fluid delivery tubing 150 which is ulti mately in fluid
42. istally connected to electrode 114a as discussed in greater detail below As also shown in FIG 8 wire conductor 355 of wire 346 first connects through hand switch assembly 162 before connecting preferably be welding to wire conductor 1585 of insulated wire 1605 which is distally connected to electrode 1145 as discussed in greater detail below Finally wire conductor 35c of wire 34c is connected to hand switch assembly 162 to alert electrosur gical unit 14 to provide power when the circuit for the switch assembly has been closed through depression of hand switch push button 164 preferably made of a rigid polymer such as polyacetal In addition to FIG 8 switch assembly 162 is shown in FIGS 9 and 10 As best shown in FIG 10 switch assembly 162 comprises a push button 164 and a dome switch 172 having two electrical contacts The contacts preferably com prise upper and lower contacts disposed on a platform 174 in overlying relationship Preferably the upper contact com prises a dome shaped configuration overlying and spaced from the lower contact which is flat Preferably the contacts are spaced from one another by virtue of the domed configu ration of the upper contact when the button 164 is in an undepressed position thus creating an open control circuit relative to switch 172 However when the top of button 164 is pressed and the upper contact is correspondingly pressed into a depressed position the upper contact comes into contact
43. m the same drawbacks as prior art dry tip electrosurgical devices The use of the disclosed devices can result in significantly lower blood loss during surgical procedures Such a reduction in blood loss can reduce or eliminate the need for blood transfusions and thus the cost and negative clinical consequences associated with blood transfusions such as prolonged hospitalization While a preferred embodiment ofthe present invention has been described it should be understood that various changes adaptations and modifications can be made therein without departing from the spirit ofthe invention and the scope ofthe appended claims The scope of the invention should there fore be determined not with reference to the above descrip tion but instead should be determined with reference to the appended claims along with their full scope of equivalents Furthermore it should be understood that the appended claims do not necessarily comprise the broadest scope of the 20 25 35 40 45 50 55 60 65 16 invention which the Applicant is entitled to claim or the only manner s in which the invention may be claimed or that all recited features are necessary All publications and patent documents cited in this appli cation are incorporated by reference in their entirety for all purposes to the extent they are consistent What is claimed 1 A bipolar electrosurgical device to treat tissue in a pres ence of radio frequency p
44. ng distally from the handle the shaft sup porting the distal portion ofthe device in rigid relation to the handle the distal portion ofthe device terminating at a distal end of the device the distal end of the device comprising a disc shaped distal end having a bipolar electrode configura tion US 8 216 233 B2 19 the disc shaped distal end comprising a first semi circular shaped electrode that serves as a first pole of the bipolar electrode configuration and a second semi circular shaped electrode that serves as a second pole of the bipolar electrode configuration a fluid delivery passage being connectable to a fluid source at least one fluid exit in fluid communication with the fluid delivery passage and configured to provide fluid to an exterior of the device at the distal portion of the device and an electrical insulator sandwiched between the first semi circular shaped electrode and the second semi circular shaped electrode wherein the fluid exit is formed by the electrical insulator 36 The device according to claim 35 wherein the electri cal insulator defines a portion of the fluid delivery passage 37 The device according to claim 35 wherein the fluid delivery passage passes between the first semi circular shaped electrode and the second semi circular shaped elec trode 38 The device according to claim 35 further comprising a housing that secures the first semi circular shaped electrode and the second sem
45. nnect the main power cord to the electrosurgical unit 14 and an equipotential grounding lug connector 66 used to connect the electrosurgical unit 14 to earth ground using a suitable cable The rear panel also includes a removable cap 68 for the installation of a bipolar footswitch socket connectable to an internal footswitch cir cuit of electrosurgical unit 14 so that the RF power may be activated by a footswitch in addition to a handswitch of device 30 Additionally the rear panel also includes a fuse drawer 70 which includes which contains two extra fuses consistent with the line voltage Finally the rear panel includes a name 0 40 45 55 65 6 plate 72 which may provide information such as the model number serial number nominal line voltages frequency cur rent and fuse rating information ofthe electrosurgical unit 14 The RF power output curve of electrosurgical unit 14 is shown in FIG 4 Impedance Z shown in units of ohms on the X axis and output power Po is shown in units of watts on the Y axis In the illustrated embodiment the bipolar electrosur gical power RF is set to 200 watts As shown in the figure for an RF power setting P of 200 watts the output power will remain constant with the set RF power as long as the impedance Z stays between the low impedance cut off of 30 ohms and the high impedance cut off of 125 ohms Below an impedance Z of 30 ohms the output power Po will decrease as shown
46. o the first semi circular shaped electrode at one of the first electrode first corner and the first electrode second corner 17 The device according to claim 1 wherein the first semi circular shaped electrode comprises a first electrode first corner and a first electrode second corner and the at least one fluid exit is adjacent to one of the first electrode first corner and the first electrode second cor ner 18 The device according to claim 17 wherein the second semi circular shaped electrode comprises a sec ond electrode first corner and a second electrode second corner and the at least one fluid exit is adjacent to at least one of the first electrode first corner the first electrode second cor ner the second electrode first corner and the second electrode second corner 19 The device according to claim 1 wherein the first semi circular shaped electrode has a semi circular shaped perimeter extending from a first electrode first corner to a first electrode second corner and the at least one fluid exit is closest to the first semi circular shaped electrode at one of the first electrode first corner and the first electrode second corner 20 The device according to claim 1 wherein the at least one fluid exit comprises at least two fluid exits 21 The device according to claim 20 wherein the at least two fluid exits are located on opposing sides of the device 20 25 30 40 45 55 60 65 18 22
47. ower and a fluid provided simulta neously from a distal portion of the device the device com prising a handle a shaft extending distally from the handle the shaft sup porting the distal portion ofthe device in rigid relation to the handle the distal portion ofthe device terminating at a distal end of the device the distal end of the device comprising a disc shaped distal end having a bipolar electrode configura tion the disc shaped distal end comprising a first semi circular shaped electrode that serves as a first pole ofthe bipolar electrode configuration and a second semi circular shaped electrode that serves as a second pole of the bipolar electrode configuration a fluid delivery passage being connectable to a fluid source and at least one fluid exit in fluid communication with the fluid delivery passage and configured to provide fluid to an exterior of the device at the distal portion of the device wherein the first semi circular shaped electrode and the second semi circular shaped electrode are spaced apart by an electrically insulative material and wherein the at least one fluid exit is formed in the electri cally insulative material 2 The device according to claim 1 wherein the first semi circular shaped electrode has a shape ofabout a first half of a circle and the second semi circular shaped electrode has a shape of about a second half of the circle 3 The device according to claim 1 wherein the first
48. plurality of electrically insulated wire conductors and at least one plug 36 at the end thereof The electrosurgical unit 14 provides radio frequency RF energy power via cable 34 to electrosurgical device 30 As shownin FIG 2 plug receptacle 38 of electrosurgical unit 14 receives the plug 36 of device 30 therein to electrically connect device 30 to the electrosurgical unit 14 Preferably the fluid delivery tubing 28 is provided as part of cable 34 and produced with the electrically insulated wires via plastic co extrusion FIG 2 shows the front panel ofthe electrosurgical unit 14 power switch 42 is used to turn the electrosurgical unit 14 on and off After turning the electrosurgical unit 14 on the RF power setting display 44 is used to display the RF power setting numerically in watts Preferably the power setting display comprises a liquid crystal display LCD Addition ally this display 44 is used to display errors in which case the display 44 will show Err and blink alternately with a special error code number s The RF power selector comprises RF power setting switches 46a 46b which are used to select the RF power US 8 216 233 B2 5 setting Pushing the switch 46a increases the RF power set ting while pushing the switch 465 decreases the RF power setting RF power output may be set in 5 watt increments in the range of 20 to 100 watts and 10 watt increments in the range of 100 to 200 watts Additionally electrosur
49. rner 1495 of electrode 1146 In other embodiments as shown in FIGS 15 and 16 the semi circular shaped side perimeter 151a 1515 of electrodes 114a 1145 for device 30d is covered by an electrical insula tion preferably provided by outer housing portion 112 to eliminate the semi circular shaped perimeter 151a 1515 of electrodes 114a 1145 from being used to treat tissue As shown the semi circular shaped perimeter 151a 1515 of electrodes 114a 1145 is covered by a ring shaped portion of outer housing portion 112 During use of device 30a fluid 24 from fluid source 22 is communicated through a fluid passage which provided by various structures Fluid 24 from the fluid source 22 15 first communicated through lumen 29 of delivery tubing 28 As shown in FIG 8 fluid 24 then feeds into a lumen 156 of a size reduction bushing 154 located within handle 104 and then into lumen 152 of tubing 150 which is contained in the lumen 124 of shaft 102 as shown in FIG 12 From lumen 152 of tubing 150 fluid 24 then flows through bore 140 then into bore 144 and is expelled from holes 146a 1465 In the present embodiment which makes use of a peristaltic pump 32 a special pump tubing segment 182 as shown in FIG 7 designed to operate specifically with the peristaltic pump 32 may be spliced in between portions of delivery tubing 28 and connected thereto using barbed fluid line connectors 180 at each end thereof The relationship between the material
50. stomoses prevertebral anastomoses and a main dorsal branch as they approach the neural foramina This main dorsal branch continues posteriorly below the transverse process of the vertebrae supplying the bone ofthe posterior elements of the vertebrae and the paraspinal muscles Shortly after its origin the dorsal branch gives off a spinal branch which supplies the anterior radicular artery and anterior segmental medullary artery which ultimately sup plies the anterior spinal artery The spinal branch also sup plies a branch to the vertebral body and dura mater and the posterior radicular artery which ultimately supplies the pos terior spinal arteries During a posterior discectomy the devices of the present invention may be more particularly used by a surgeon to seal veins of the posterior external vertebral venous plexus pos terior internal vertebral epidural venous plexus and anterior internal vertebral epidural venous plexus prior to entering the intervertebral disc space Alternatively during an anterior discectomy the devices of the present invention may be more particularly used by a surgeon to seal veins of the anterior external vertebral venous plexus and segmental arteries par ticularly the anterior and lateral anterior portions adjacent the vertebral bodies During a discectomy blood vessels are often cut ruptured or otherwise severed These blood vessels bleed and the resulting blood can flow into the tissue treatment
51. tem around the vertebral bodies the posterior external vertebral venous plexus the system around the ver tebral processes the anterior internal vertebral epidural venous plexus the system running the length ofthe vertebral canal anterior to the dura and the posterior internal vertebral epidural venous plexus the system running the length ofthe vertebral canal posterior to the dura with the latter two constituting the epidural venous plexus The veins of the exterior vertebral venous plexus communicate with the veins of the interior vertebral venous plexus through intervertebral veins and anterior and posterior segmental medullary radicu lar veins of each vertebral level The vertebral arterial system includes the segmental arter ies of the vertebral column which supply anterior and poste rior radicular arteries of the various vertebral levels In tho racic and lumbar regions segmental arteries include the posterior intercostal subcostal and lumbar arteries which arise from posterior aspect of the aorta The blood supply to the spinal column is derived from the segmental arteries which supply two networks one feeds the bony elements of US 8 216 233 B2 13 the vertebrae the paraspinal muscles and the extradural space and the other an inner network nourishes the spinal cord itself Extending from the aorta the segmental arteries hug the perimeter of the vertebral bodies of the vertebrae giving off paravertebral ana
52. tion during the treatment of tissue How ever too much saline can provide too much electrical disper sion and cooling at the electrode tissue interface This reduces the temperature of the tissue being treated and in turn can result in a longer treatment time to achieve the desired tissue temperature for treatment 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 In light of the above there is a need for devices and meth ods which address the foregoing concerns SUMMARY OF THE INVENTION The invention in one embodiment provides an electrosur gical apparatus to provide controlled delivery of radio fre quency power and a fluid to an electrosurgical hand held device to treat tissue The apparatus comprises a radio fre quency generator to deliver the radio frequency power with the radio frequency power from the radio frequency genera tor selectable at a radio frequency power level a pump to deliver the fluid a primer to prime the hand device with the fluid a control system to control a flow ofthe fluid delivered by the pump with a functional relationship between the radio frequency power level and the flow ofthe fluid the functional relationship to increase the flow ofthe fluid in response to an increase in the radio frequency power level and to decrease the flow of the fluid in response to a
53. udinal cross sectional view of a distal portion of the device of FIG 7 FIG 13 is a close up longitudinal cross sectional view of a distal portion of an alternative exemplary electrosurgical device according to the present invention FIG 14 is a close up longitudinal cross sectional view of a distal portion of an alternative exemplary electrosurgical device according to the present invention FIG 15 is an isometric view of a distal portion of an alternative exemplary electrosurgical device according to the present invention FIG 16 is a close up longitudinal cross sectional view of the distal portion of the device of FIG 15 taken along line 16 16 and FIG 17 is a close up view of a distal portion of the device of FIG 7 and tissue FIG 18 is a close up view of a distal portion of the device of FIG 7 pressing against tissue FIG 19 is a close up view of a distal portion of the device of FIG 7 being used to treat tissue and FIG 20 is a close up view distal portion of the device of FIG 7 removed from treated tissue DETAILED DESCRIPTION Throughout the description like reference numerals and letters indicate corresponding structure throughout the sev eral views Also any particular feature s of a particular exemplary embodiment may be equally applied to any other exemplary embodiment s of this specification as suitable In other words features between the various exemplary embodi ments described herein are inter
54. urface 202 of tissue 200 and forms a shunt between electrodes 114a 114b Given this scenario a certain amount of RF energy may be diverted from going into tissue 200 and actually pass between electrodes 114a 1145 via the conduc tive fluid bridge This loss of RF energy may slow down the process oftreating the tissue However for device 30a having this coupling located between the opposing corners 148a and 1482 and or opposing corners 149a 1495 of electrodes 114a 1142 respectively may be desirable as the tissue adja cent to these corners may heat faster or get hotter than other tissue being treated due to the electrode configuration In such a case having the fluid coupling 204 at these locations may provide for more balanced heating and treating of tissue 200 Consequently it may be desirable to provide fluid 24 from device 30a in such a quantity that a small portion of the fluid boils to dissipate heat from the tissue while at the same time the fluid diverts a certain amount of RF energy from going into tissue 200 at locations which may heat faster or get hotter than other tissue being treated FIG 20 shows device 30a removed from tissue 200 with the blood vessel 220 sealed against blood loss and blood flow there through As established above the bipolar devices of the present invention inhibit such undesirable effects of tissue desicca tion electrode sticking char formation and smoke genera tion and thus do not suffer fro
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