TransDiscal™ User Guide
Contents
1. Ensure that all connections are made TransDiscal Y Connecting Cable to PMG TD TransDiscal Introducer or TransDiscal Probe to Y Connecting Cable Grounding Pad to PMG TD in optional placement mode Check for an error message on the PMG TD Possible error codes include W208 W209 W210 E125 and E126 Follow flow chart for trouble shooting actions Visually inspect the probes and cables for damage In Treatment Mode ensure the probes are fully inserted into the introducers Ensure that the devices are dry and at room temperature Fluid is not circulating Pump Pain Management Tube Check for an error message on the generator Possible error codes include E101 during TransDiscal Kit TransDiscal Probe and BMC E103 and E106 Follow flow chart for trouble shooting actions Treatment Mode RF Generator Follow the fluid pathway along the tubing and probes to see if it is pinched or kinked For example if clamps are used to hold the tubing they should not pinch it Check to see that the tubing is properly placed in the L shaped tubing guides of the Pump Unit and in the correct direction Page 43 of 53 Possible Device Trouble Shooting Actions Check to see that burette reservoir has been filled Check to see that the float in the burette is not stuck at the bottom and occluding the flow of water from the burette Check to the see that the Tube Kit is correctly connected to the luer locks on the TransDiscal Probes Ensure that th2. Page 20 of 53 Placement Technique A technique for placing introducers and TransDiscal Probes in the annulus as suggested by Dr William Whyte is described below 1 Ascertain the disc level to be treated by locating the T12 vertebra with ribs and count the levels moving caudal Obtain a true AP view of the disc to be treated This is confirmed by flat endplates and equal distance between the pedicles and the Spinous process 2 While maintaining the sagittal angle rotate the c arm obliquely until it is parallel to the pedicle This angle is approximately 30 40 and shows a clear image of the Scotty dog The Superior Articular Process SAP or the ear of the Scotty dog should be seen superimposed over the disc with approximately 1 4 to 1 3 the disc width lateral to the SAP A path to the entry target of the disc can be seen lateral to the SAP Page 21 of 53 A note on incorrect oblique angle If the oblique angle is too large If the SAP is at more than 1 3 of the disc width the oblique angle will be too large and the probes might be placed too far from the lateral edges of the disc A fluoroscopic image of a lumbar If the oblique angle is too large the spine with the C arm at resulting placement of introducers will be approximately 45 The SAP too medial and the lateral portions of the appears about 1 2 the disc width disc may not be heated If the oblique angle is too small lf the SAP is at less than
3. 53 13 Remove the stylet from the other introducer and insert the second probe 14 Make slight depth adjustments to both probes in a lateral view Ideally the distal tip of the probe is no further than the center of the disc The radiopaque band denotes the beginning of the electrode and it must be within the disc space This lateral view shows two probes one in each introducer In a true lateral view the probes are almost superimposed on one another The C arm is swiveled slightly to reveal both probes 15 Check the placement on an AP view Ideally the distal tips of the probes are inserted to medial edges of the pedicles The radiopaque bands and the rest of the electrode must be within the disc space Page 26 of 53 8 Procedure Parameters Overview This section describes the parameters used to control the heating profile during the procedure In this section you will learn e What the modifiable parameters are e How the parameters affect the heating e Suggested parameters to use Parameters used to create heating profile The parameters available to control the heating profile are Ramp Rate Set Temperature Time 50 Set Temperature 45 40 Temperature ww on Ramp Rate C minute 30 25 Time Time There are temperature sensors in the TransDiscal Probes The generator will automatically deliver the required power to raise the temperature of the probes according t
4. Generator Or Erratic temperature reading Check for error messages on the generator Possible error codes include E101 E103 and E106 Follow flow chart for trouble shooting actions Ensure that all connections are made probe s to Y Connecting Cable Y Connecting Cable to the generator Generator to power outlet Check for an error message on the generator Possible error codes include E108 E109 E107 E110 E123 and E124 Follow flow chart for trouble shooting actions Visually inspect the probe or cable for damage Ensure that devices are dry and at room temperature If problem persists discontinue use Small oscillations or spikes might be seen in temperature during treatment mode This may be due to the probe or patient moving Check the fluoroscopy image to confirm the probes have not moved to an unsafe location If they have moved stop the procedure press the Output On Off Button and reposition the probes If very large oscillations or spikes gt 15 C are seen a probe might be damaged Visually inspect the probes and discard if damaged Page 45 of 53 BMC Generator Error Fault Codes for TransDiscal Mode e lf an error fault condition should occur a pop up message will display an error fault code in the center of the screen e The error fault event text message displayed including possible cause error fault code and recoverable non recoverable indications regarding TransDiscal Mode are listed in Tabl
5. Page 33 of 53 Home Exercise Program 0 6 weeks NO TWISTING For activites like getting out of a car or putting dishes in the dish drain make sure you move your feet instead of twisting your back To get in and out of bed rall onto side first and keep your back straight eat ear TS LIFTING Limit lifting to 0 10 lbs for the first amp weeks Make sure to keep the object close to your body and keep your back straight by kneeling or squatting The Saude drup bee Golfer s Lift To reach a light object on the ground use the Golfer s Lift Place your weight on one lag Lean on your putter for balance Band over at the hip keeping the back straight as you let the other leg extend behind you The Seasniders Gesu inte Light Housework NO BENDING Light housework may be resumed after 1 week but with good body mechanics Notice the forward bent rounded back in a weak position left versus the slightly arched safer knealing position right The Saurders Group Ine Built on Tools RG 1206 2005 fz Page 34 of 53 DRIVING No driving for 1 week As a passenger recline the seal and try to limit riding times to lass than 45 minutes for the first 6 weeks Itis OK to recline and be driven home the day of your procedure or lia down in the back seat For weeks 2 6 limit driving to 20 30 min and use a lumbar roll when sitting to support the arch in your lower back RETUR
6. abnormal procedure graph The figures in this section represent screens of a Baylis Pain Management Generator Model PMG 115 TD and PMG 230 TD V2 0 to 2 1 Refer to the generator s user manual for complete details The graph on the generator shows the maximum of the two electrode temperatures TRANSDISCAL TEMP in yellow the maximum of the two peripheral temperatures PERIPHERAL DISC TEMP in white and the power POWER in magenta An ideal procedure graph as shown in Figure 10 has fairly smooth lines with the TRANSDISCAL TEMP increasing more than the PERIPHERAL TEMP This indicates that the temperature in the disc is increasing more than at the edge of the disc The POWER is also a smooth line increasing to a plateau of about 5 to 7 watts eMC BAYLIS MEDICAL COMPANY INC j MEASUREMENTS SETTINGS LSS TIME min TRANSDISCA PERIPHERAL SET TEMP Jj C MP J c FB DISC 33 C E i 174010 Ete fo ST TRANSDISCAL DATA TIME min i I E 40 i i C J J A ax A Figure 10 Generator graph of an ideal procedure Page 29 of 53 The graph in Figure 11 is similar to the ideal graph except there is a small blip in the three lines at about 7minutes This is commonly seen if the patient moves to get more comfortable or coughs It may also be seen if the probes are bumped or moved This is likely not a problem but it is a good idea to check the lateral and AP fluor
7. 1 4 of the disc width the oblique angle is not enough and the probes may be placed too close to the lateral edges of the disc A fluoroscopy image of a lumbar If the oblique angle is too small the spine with the C arm at resulting placement of introducers will be approximately 10 The SAP too lateral and the tissue lateral to the disc appears about 1 5 the disc width may be heated Page 22 of 53 Under fluoroscopy place a radiopaque tool such as Kelly s clamps on the surface of the skin directly over the entry target of the disc Mark the entry point on the skin with a sterile marker Inject local anesthetic along the introducer tract Avoid anesthetizing the area around the spinal nerve so the patient can respond to any sensations indicating potential injury to the nerve Maintain the oblique view and advance the introducer to the disc This can be done by using live fluoroscopy or by using multiple shots of X ray When using live fluoroscopy hold the introducer by the hub with clamps and gently advance the introducer to the annulus fibrosus aiming for the middle of the disc height When using multiple shots of X ray advance the introducer a little at a time until the target is reached Page 23 of 53 7 Because the annulus is a harder tissue than the soft muscles the annulus can be felt as the introducer makes contact Anchor the introducer within the disc 8 Verify that the introducer is anchored in the
8. N TO WORK Sedentary work You may retum in roughly 1 week however you may stl be sore procedure Be aware of your sitting restrictions if your job is more than sedentary work please consult your physician for return to work status SITTING Limit sitting to 30 45 minutes at any one time in a chair with good support for the first 5weeks Avoid siting on sof couches or chairs Use a pillow or towel roll behind your low back to helg support the arch in your low back Standing walking or lying down in between sitting periods is helpful WALKING Walk daily beginning at the end of the first week for approximately 20 minutas Increase to 20 minutes twice per day if tolerated then progressively increase to 1 hour a day by the end of the fourth wask If back or leg symptoms increase at any point decrease the duration of walking CORSET Wear your corse all the tine for the first 6 8 weeks You do not need to wear it to bed or to shower i The Poni Ahing Pederson Bull on Tools RG 12 06 2006 ae Page 35 of 53 Week 1 6 PhysigTeots Lad Presa Toces Lid G PtyceoT one List Lying face down Squeeze your buttocks strongly together Hold 5 sec Repeat 10 times 2x day Lying face down with a belt or towel around your ankle Tighten your stomach musclas to keep your lower back straight Bend your knee and pull the belt with both hands until you feel tightness on the front of y
9. TransDiscal System for Disc Biacuplasty User Guide Baylis Medical Company Inc 15 August 2006 Version 2 0 Baylis Medical Company Inc 2006 TransDiscal is a trademark of Baylis Medical Company 1 Table of Contents ie DEO COM tei niea ete oe sass atic E EEE A supe eget 2 2 0 6 18 6 g eee ner eee ene ee a er REM RT ere oe eee weer vere nee 2 3 Physics of the TransDiscCal SYSteM arrenden a Aiti 3 4 Technical Description of the EQUIDMeNT ccccccccssececeeseesseseeenenereceeesensanees 10 5 Paent Se lS CUO aA daesiastap ceeneannmemutodduaes 12 Os SCP INSTUCIONS seccoicct ct eactoetsuacectoectcetstateret a 13 ke Placement GUIGGSINGS sessir ENE 19 89 Procedwe Paramete eepose rnin eE A ENRE 27 9 Generator Graphs during Treatment ccccccccccsseececeeeeeceeeecseeeecsuesesseeeeessaaees 29 10 PostProcedural Oatesin E a 32 11 TrouDleShootiNg ssaa a A 41 12 ROIGTONCOS ainoaan AT E ENOS 52 2 Introduction The TransDiscal System in combination with the Baylis Pain Management Generator TD PMG TD is indicated for the coagulation and decompression of intervertebral disc material to treat symptomatic patients with contained herniated discs The procedure is called intervertebral disc biacuplasty and the equipment used for the procedure is called the TransDiscal System In this procedure two TransDiscal Introducers are placed within the disc with a bilateral approach A TransDiscal Probe wi
10. a material due to lower conductance the more energy is used The energy that is used does not disappear but is converted to a different form of Page 3 of 53 energy often in the form of heat The conversion of electrical energy to thermal energy by passing current through a material with resistance is called resistive heating A good example of resistive heating is an electric toaster The metal filament in the toaster is made of nickel and chromium which has an ideal resistance to convert electricity to heat Biological tissue is not a very good conductor when using direct current Resistive heat can be generated but the flow of current cannot be controlled easily and it can damage the cells Using direct current to heat tissue may produce unpredictable tissue temperatures and irregular shaped lesions Excessive temperatures would lead to burning of tissue gas formation and uncontrolled destruction of tissue lonic Heating with AC Another way electrical energy is converted to heat in tissue is by ionic heating To overcome the drawback of direct current use of alternating current for medical applications was pioneered by Cushing and Bovie in the 1920s originally for hemostasis Later in the 1950s Aranow and Cosman deployed alternating current for creating neural lesions Alternating current conducts through tissue with less resistance and more control than direct current The greater the alternating current frequency the greater t
11. ach out of the sterile field TransDiscal Introducer Model TDIB 17 150 Important features Two introducers are required for a procedure 4 An introducer is comprised of a fully insulated sO cannula and a sharp trocar tipped stylet i Model TDI 17 150 includes a cable attached to the stylet which allows impedance monitoring by the generator which can be used as a placement aid The 17 gauge introducer allows for accurate placement of the probe Pain Management Tube Kit Model TDA TBK 1 Important features Two tube kits are required for a procedure p Each is used for circulation of sterile Ves water through the TransDiscal A Probes for the purpose of cooling the electrodes uy The Pain Management Pump Unit pumps water through the tube kits The Tube Kit comprises medical grade tubing and a burette that A holds sterile water Page 11 of 53 5 Patient Selection Candidates for disc biacuplasty using the TransDiscal System must have a history of chronic back pain originating from the disc for greater than 6 months and meet the following selection criteria Inclusion Criteria Patients must meet all of the inclusion criteria Criteria for discogenic pain satisfied viz o Predominant axial mechanical pain o Demonstration of positive concordant pain of intensity gt 6 10 during provocative lumbar discography at 1 or 2 disc levels at low pressures lt 50 psi with negative control disc at one an
12. ame surface area The same amount of current flows through both electrodes and since the surface area is the same the current density is the same Figure 3b This results in the same ionic heating around each pole A given amount of current in a bipolar system can heat twice the volume of tissue as the same amount of current in a monopolar system Page 5 of 53 Electrically Grounding pad Electrically Return Electrode active with relatively active with the same electrode large surface electrode surface area area a Monopolar b Bipolar Figure 3 A representation of monopolar and bipolar systems for RF heating lonic heating is limited by decreasing current density and increasing tissue impedance These effects mean that monopolar systems are good for creating small lesions but are of limited value when attempting to create larger lesions In general monopolar systems produce focal ellipsoid lesions less than 1 6 cm in diameter For larger lesions multiple usage of the monopolar RF is inefficient and inconsistent Bipolar systems can heat twice the volume of monopolar systems Furthermore if the two electrodes are sufficiently close to one another a strip lesion is formed between the two electrodes as shown in Figure 4 Simultaneous RF ablation using two electrodes in close proximity has been shown to produce a larger lesion compared with two sequential monopolar ablations using single electrodes This effect is creat
13. ble is securely connected Pump unit may be defective 4 Dynamic Probe Pump Mapping Failure Check probe and cable connections ensure fluid circuitry is connected correctly and free from obstruction Probe s or cable s may be defective Contact technical support if problem persists A Pump Current Limit Check pump unit and ensure cable is securely connected Contact technical support if problem persists A Cooled Temperature Out Of Range Outside 18 34 C expected range Probe s cable s or pump unit may be defective A TDP B Connected But Disabled In Advanced Settings Disconnect TDP B or if desired enable 2 PROBES in ADVANCED TRANSDISCAL SETTINGS Page 47 of 53 LCD Text Message A TDP A Not Connected Check probe and cable connections Probe or cable s may be defective A TDP B Not Connected Check probe and cable connections If desired enable 1 PROBE in ADVANCED TRANSDISCAL SETTINGS A TDP A and TDP B Not Connected Check probe and cable connections Probe s or cable s may be defective A TDP A Connected to Wrong Side of Y Cable Disconnect probe and attach to other side of Y cable A Invalid TDP A Temperature Reading Check probe and cable connections Probe or cable s may be defective Try new probe and cable s if problem persists A Invalid TDP B Temperature Reading Check probe and cable connections Probe or cable s may be defective Try new probe and cable s if pro
14. blem persists A High Impedance Detected Check probe and cable connections Possible poor tissue contact Probe s or cable s may be defective LCD Text Message A Low Impedance Detected Possible short circuit between electrodes or damaged introducer insulation A High Impedance Detected Check probe cable and dispersive return electrode connections Possible poor tissue contact Probe or cable may be defective A TDP B Connected But Disabled In ADVANCED SETTINGS Disconnect TDP B or if desired enable 2 PROBES in ADVANCED TRANSDISCAL SETTINGS A High Impedance Detected Check stylet probe cable and dispersive return electrode connections Possible poor tissue contact Stylet probe or cable may be defective Stylet probe may be connected to wrong leg of Y cable A Low Impedance Detected Possible short circuit between electrodes or damaged introducer insulation A High Impedance Detected Check probe and cable connections Possible poor tissue contact Probe s or cable s may be defective Page 48 of 53 Loose connections Trouble Shooting Flow Chart Legend Errors 80 to 88 ae Error Persists EEE Error Clears gt See additional Error 80 to 86 Error 87 to 88 a Ensure connectors are dry Check connections After drying if error clears moisture on the connector caused the error Not necessary for E80 Reposition Indepen
15. ct the female connector of the Pain Management Pump Connector Cable to the Pump Unit e Push the connectors as far in as possible and then tighten by turning the collar clockwise 2 Plug in the Generator e Plug the power cord into the Pain Management Generator and connect the generator directly to a grounded receptacle e Turn the generator on Page 14 of 53 Insert Tube Kits into the Pain Management Pump Unit Remove the Pain Management Tube Kits from the sterile package Put the burettes into the Pump Unit s burette holders Open the pump head lids and thread the thicker tubing from the bottom of the burette into the pump head tube holders Ensure that the tubing is properly placed between the notches Improper positioning of the tubing can pinch the tube and restrict the water flow Close the lid in order to hold the tubing in place Leave the luer lock caps on the tubing until you are ready to connect the probes so the inner pathway of the tube kit remains sterile Fill the burettes with sterile water Remove the cap of the burette Using a sterile syringe fill the burettes with 70 ml of sterile water or saline at room temperature Repeat with the second burette Page 15 of 53 5 Connect the TransDiscal Introducers to the generator for impedance guided placement optional e The TransDiscal Introducers model TDIB 17 150 sold separately can be placed using optional Impedance Guided Placement as follows Co
16. d The water cooling of the electrodes also prevents charring of tissue adjacent to the electrode The greater power dissipation also contributes to the creation of a larger strip lesion between the electrodes Other minimally invasive treatments create very high tissue temperatures adjacent to the electrode which may result in charring of tissue Tissue charring can result in an irregularly shaped lesion and increase tissue impedances preventing power to be dispersed farther into the tissue Temperature Control Temperature sensors at the electrode tips allow the RF generator to control the power delivery and the rate of internal electrode cooling The temperatures at the electrode tips are reflective of the surface of the cooled electrodes and not the maximum lesion temperature Safe amp Easy Placement Placement of the TransDiscal probes is straight forward and results in minimal disturbance to the disc tissue Other minimally invasive treatments use a long flexible catheter to treat the entire posterior area The flexible catheter may take additional time to position correctly and create extraneous channels within the disc Impedance Monitoring for Accurate Placement The TransDiscal system is equipped with impedance monitoring that allows for accurate placement given that impedance varies between different tissue types Once the TransDiscal System introducer penetrates the annulus fibrosus of the disc the impedance decreases If t
17. d preferably two adjacent levels and sham pressurization o Physical examination Chronic pain gt 6 months Age greater than 18 years At least 50 preserved disc height Failure to achieve adequate improvement with comprehensive non operative treatment including non steroidal anti inflammatory physical therapy and fluoroscopically guided epidural steroid injection in and around area of pathology Other possible causes of low back pain have been ruled out eg failure to obtain prolonged improvement gt 14 days from facet injections sacroiliac joint injections or RF rhizotomies Exclusion Criteria Patients will be excluded if they meet any of the following criteria Neurological deficit Intervertebral disc herniations greater than 4mm Extruded sequestered intervertebral disc herniations Spinal pathology that may impede recovery such as spina bifida occulta spondylolisthesis at the painful segmental level or scoliosis Moderate to severe foraminal or central canal stenosis Pregnancy Existing endplate damage or Schmorl s nodes Greater than grade 4 annular tear Modified Dallas Grading Systemic infection or localized infection at the anticipated introducer entry site History of coagulopathy or unexplained bleeding Relative Contraindications Body Mass Index greater than 29 9 obese Irreversible psychological barriers to recovery Prior lumbar spine surgery Radiculopathy Ilmmunosuppressed eg AIDS cance
18. dently One of the probe ensure swap probe and devices is probe is fully cable damaged inserted into introducer Swap probe Both of the and cable at the devices are same time damaged Probe may have had poor tissue contact or not fully inserted in introducer Internal error resolved by reboot Turn PMG ON OFF Internal error requires repair Call Clinical Support Page 49 of 53 Trouble Shooting Flow Chart Legend Error Persists gt Errors 101 103 and 104 ap Error Clears gt See additional text Check all connections Loose or improper connections Loose connection Ensure pump PMG connection cable is secure Ensure pump lids are closed Ensure tubing _ Tubing is correctly sr placed within placed within henin pump heads amen p Pump lids were open Tube kit Ensure tube incorrectly kit tubing is connected to connected Y probes correctly to able the probes Ensure water Swap Occluded is flowing TransDiscal Y tube kit through the Connecting tube kit and Cable float ball is floating Damaged Independently Probe swap TransDiscal Probes Internal error requires repair Call Clinical Support Page 50 of 53 Trouble Shooting Flow Chart Legend Error Persists Errors 106 108 to 125 EEE Error Clears gt See additi
19. disc by using live fluoroscopy while gently flicking the introducer The introducer can be seen moving in soft tissue but the tip will be held in place in the annulus 9 Advance the introducer approximately 1 cm into the disc The depth markings on the introducer are spaced apart by 1 cm In an AP view the tip of the introducer is advanced from point A to point B Notice the position of lines A and B in relation to the pedicles Page 24 of 53 10 Confirm the position of the introducer in the disc with a lateral view Depth adjustments can be made later once the probe is inserted At this time the introducer should be in the disc approximately 1 cm 11 Place the other introducer in the contralateral side of the disc using the same technique 12 Remove the stylet from an introducer and insert a probe Keep the stylet in the sterile field incase the introducer needs to be repositioned Never reposition an introducer without the stylet inserted A hollow introducer is not sharp enough or strong enough and will break The probe will protrude from the introducer by 1 cm when fully inserted While keeping the probe fully inserted in the introducer pull them back so the distal tip of the introducer is near the edge of the disc and the probe is about 1 cm into the disc This lateral view shows an introducer that is in the left side of the disc and a probe that is inserted into the introducer on the right side Page 25 of
20. e 1 NOTE For recoverable faults the error code is displayed for approximately 10 seconds the Generator will automatically transition back to the previous READY state or to the POST COOLING state if generated from the TRANSDISCAL TREATMENT ON state Page 46 of 53 Table 1 TransDiscal Error Fault code interpretation LCD Text Message A Measured Temperature Exceeds Setpoint Possible high impedance or desiccated tissue at probe tip A Measured Power Exceeds Setpoint Please check all probe and cable connections Possible intermittent cable or poor tissue contact A Excessive RF Current Measured Possible short between electrodes or defective probe or cable A Excessive RF Voltage Measured Possible intermittent cable connection or loss of tissue contact A Excessive RF Power Measured Possible intermittent tissue contact Possible defective probe s or cable s A High Impedance Detected Check probe cable and dispersive return electrode connections Possible poor tissue contact Probe or cable may be defective A Unrecognized Probe Type See User Manual for a list of valid probes Please note error code and contact technical support if problem persists LCD Text Message A Invalid Temperature Reading Please check probe and cable connections Possible defective probe or cable If problem persists try new probe and cable A Pump Malfunction Ensure pump lids are fully closed and ca
21. e portion of tubing that is in the pump head is the thick tubing coming out of the bottom port of the burette and NOT the thin tubing coming from the top of the burette Check for leaks or occlusions in tubing and joints of the Tube Kit Ensure that the pump head lid is closed abnormal noises correct direction This is normal The PMG TD will alter the pump speeds in order to maintain similar at different speeds TransDiscal Probe tip temperatures One pump head stops Pain Management Pump Unit This is normal The PMG TD stops the pumps during pretreatment cooling so the during Pretreatment generator can identify which probe is associated to which pump head Cooling Only one Pump is BMC RF Generator Check to see that you have enabled 2 probes for treatment in the TransDiscal Rotating during Advanced Settings on the PMG TD Treatment Mode Water is not dripping Pain Management Tube Kit If water is not dripping into the burette check to see if it is running down the wall of into the burette the burette The pump is not working Pain Management Pump Unit Ensure that the Pump Unit is connected to the PMG TD when in TransDiscal Treatment Mode ready Ensure the pump head lids are completely closed Open and close both pump lids pre cooling on post and try again cooling states Page 44 of 53 Possible Device Trouble Shooting Actions No temperature TransDiscal Probe measurement TransDiscal Y Connecting Cable and BMC RF
22. ed because the RF current is concentrated between the electrodes Page 6 of 53 Figure 4 Creating a strip lesion A Two single lesions are formed if the electrodes are too far apart B A strip lesion that is larger than the sum of the two single lesions can be formed if the electrodes are close enough to each other Internally Cooled RF Systems Another means of increasing the volume of the lesion is by using internally cooled RF electrodes This technique was first proposed by Wittkamp in 1988 The hollow lumens of internally water cooled probes permit continuous cooling of the electrode with a fluid Internally cooled RF electrodes act as heat sinks that remove heat from tissue adjacent to the electrode Consequently time duration or power deposition can be increased during the procedure without causing high impedance and tissue charring around the electrodes As a result internally cooled electrodes can produce much larger lesions compared to non cooled electrodes Furthermore the tissue in proximity to the electrode does not need to be as hot in order to reach target temperatures at greater distances away from the electrode Figure 5 Water temperature in the range of 5 C to 25 C when used for cooled RF has been shown to not significantly affect lesion size in ex vivo hepatic ablations Alternatively increasing flow rate of the coolant has been demonstrated to significantly affect lesion 16 size The comb
23. he TransDiscal introducer enters the nucleus pulposus the impedance decreases further Thus impedance monitoring in addition to fluoroscopic imaging and tactile feel allow for accurate placement of the electrodes Other minimally invasive treatments do not offer this additional guide during placement TransDiscal System Summary The TransDiscal System creates large reproducible lesions in the posterior and posterolateral annulus fibrosus by using the advantages of e Temperature controlled radiofrequency energy application Bipolar placement Internally cooled electrodes Impedance monitoring Page 9 of 53 4 Technical Description of the Equipment Overview In this section you are going to learn about all of the components of the TransDiscal System You will learn the function of each device and the relationship of the device within the system Baylis Pain Management Generator Model PMG dove Important features e A software based computerized radiofrequency generator e Several safety features are incorporated into the control algorithm For example the generator can detect broken or improperly set up equipment and give appropriate error messages e tis designed to power and control the pump unit and provide automatically controlled parameters designed for the procedure Pain Management Pump Unit Model TDA PPU 1 Important features e The pump unit includes two peristaltic pump heads e It circulates ster
24. he conductance Alternating current causes the charged molecules or ions in the tissue to follow the directional variation of the alternating current resulting in molecular vibration The molecular vibration produces heat due to frictional forces This effect is called ionic heating The body is a complex system that uses electric current for a wide range of functions from regulating a heart beat to sending the sense of touch from a finger to the brain If alternating current is applied to the body using frequencies similar to those used by the body it can interfere with physiological functions causing unwanted effects This is avoided by using a frequency beyond those used by the body Alternating current with a very high frequency in the order of 500 kHz does not affect physiological functions RF Generators in the Market Today Today modern AC generators use a frequency between 400 and 600 kilohertz which is in the radiofrequency RF range and are generally referred to as RF generators RF generators are now equipped with automatic temperature control and impedance monitoring Temperature control allows for effective lesion formation whereas impedance monitoring detects changes in tissue resistance to electric current Impedance monitoring also aids in electrode placement because impedance varies between different tissues Monopolar and Bipolar Electrode Systems Monopolar System Physics In medical applications RF current is de
25. ile water through the TransDiscal Probes This is achieved via two closed loop fluid circuits Each closed loop fluid circuit includes a Pain Management Tube Kit and a TransDiscal Probe e The TransDiscal Pump comes with a connector cable which connects it to the generator PMG TD for power and speed control Pain Management TransDiscal Y Connecting Cable Model TDX Y TSW TDP Important features Used to connect two TransDiscal Probes to the generator Transmits RF energy from the generator to the probes Transmits signals from the temperature sensors in the probes to the generator Connects an introducer to the generator for impedance guided placement Page 10 of 53 TransDiscal Probe Model TDP 17 150 6 Important features Two probes are required for a typical procedure One probe delivers RF energy to the surrounding tissue and the second probe collects RF energy acting as the return electrode The current density Surrounding both probes is equal Sterile water is circulated internally within the electrode during the procedure which cools the electrode The sterile water is contained and does not contact patient tissue Each probe has two temperature sensors one at the distal end of the electrode and the other a few millimeters away The two temperature sensors measure temperature and provide control of RF energy delivery throughout the procedure Each probe includes a 4 cable and tubing extension to re
26. ined benefits of cooled RF with a bipolar system allow a strip lesion to be created when the electrodes are at even greater distances apart Page 7 of 53 I Temperature j Da Non cooled K 1 Cooled Probe Distance Figure 5 Temperature distribution of non cooled and cooled RF electrodes Benefits of the TransDiscal System The Baylis Medical TransDiscal System is an internally cooled bipolar RF system for thermal treatment of the intervertebral disc The aim of the TransDiscal System is to generate reproducible thermal lesions in the posterior and posterolateral annulus The system is a cooled bipolar radiofrequency system which combines the principles described above to heat a large volume of the disc RF Energy Controls Lesion Size Page 8 of 53 The TransDiscal System uses radiofrequency RF energy to heat the tissue Consequently lesions can be produced accurately predictably and safely Bipolar Arrangement Creates a Large Lesion The TransDiscal System uses a pair of electrodes in a bipolar arrangement The pair of electrodes concentrates current between the two electrodes and creates a strip lesion covering the posterior and posterolateral annulus fibrosus Other minimally invasive treatments require precise catheter placement to heat the targeted area of the disc Internally Cooled for Greater Power Applications The TransDiscal electrodes are internally cooled which allows for greater power to be use
27. ler PR Rosenthal DI 1995 Tissue ablation with radiofrequency effect of probe size duration and temperature on lesion volume Acad Radiol 2 670 674 1 Choi D Lim HK Kim MJ Lee J Kim SK Kim EY Kim S Kim SH 2003 Overlapping ablation using coaxial radiofrequency electrode and multiple cannulae system experimental study in ex vivo bovine liver Korean J Radiol 4 117 123 Lee JM Rhim H Han JK Youn BJ Kim SH Choi BI 2004 Dual Probe Radiofrequency Ablation An In Vitro Experimental study in Bovine Liver Invest Radiol 39 2 89 96 12 Wittkamp FHM Hauer RN Robles de Medina EO 1988 Radiofrequency ablation with a cooled porous electrode catheter J Am Coll Cardiol 11 17 abstract S Watanabe I Masaki R Min N Oshikawa N Okubo K Sugimura H Kojima T Saito S Ozawa Y and Kanmatsuse K 2002 Cooled tip ablation results in increased radiofrequency power delivery and lesion size in the canine heart importance of catheter tip temperature monitoring for prevention of popping and impedance rise J Intervent Card Electrophys 6 9 16 14 Lorentzen T 1996 A cooled needled electrode for radiofrequency tissue ablation thermodynamic aspects of improved performance compared with conventional needle design Acad Radiol 3 7 556 563 gt Haemmerich D Chachati L Wright AS Mahvi DM Lee FT Webster JG 2003 Hepatic radiofrequency ablation with internally cooled probes effect of coolant temperature on lesion size IEEE T
28. livered to tissue by an electrode usually on the end of a probe or insulated cannula lonic heating of tissue is a function of the current density or current per unit area RF current flows out of the electrode radially and as a result current density progressively decreases away from the electrode This is illustrated in Figure 2 where a circle represents an electrode and arrows represent the current flowing radially from the electrode The current shown by the arrows is denser in areas closer to the electrode Consequently ionic heating is greatest at the proximity of the electrode and decreases with increasing distance RF devices often contain temperature sensors Note that the electrode itself does not heat up Instead the tissue Page 4 of 53 heats from ionic heating and the heat conducts back to the electrode where the sensor indicates the tissue temperature local to the electrode This decreasing gradient of current density limits the size of the heat lesion that can be produced With a constant power a heat lesion will only grow to a limited size because the amount of heat created will come to equilibrium with the heat removed by the surrounding tissue and blood flow Figure 2 Current density represented by arrows around an electrode represented by the circle Note how the tail ends of the arrows are more concentrated at the electrode and less dense as the arrows radiate away from the electrode A way to increase the volume
29. ng connector Ensure that the connectors are clean and unobstructed Check that the connectors being connected have the same number of pins and that the pins are not damaged Fluid connectors do not TransDiscal Probe and Pain Ensure each probe and tube kit has one male and one female luer lock connect Management Tube Kit Remove the white luer lock caps The Pump will not Pump Unit and Pain Fully open the cover for the pump and place the tubing coming from the bottom of accept the Tube Kit Management Tube Kit the burette of the Tube Kit into i e above the L shaped tube Guides see step 3 in tubing the Equipment Set Up section The float ball is stuck on Pain Management Tube Kit bottom port of the Shake flick the burette to loosen the ball until it floats burette when water is injected Tube Kit breaks is Pain Management Tube Kit Discard the tube kit leaking or is occluded Page 42 of 53 Troubleshooting during treatment No Impedance TransDiscal Introducer Impedance guided placement is only available with the TransDiscal Introducer measurement TransDiscal Probe and model containing a wire TDI 17 150 TransDiscal Y Connecting Cable In Placement Mode this is normal until an introducer is inserted into the body A grounding pad is required and an introducer model with a wire attached to the stylet must be connected to Side A of the Y Connecting Cable Ensure the stylet is inserted fully into the introducer cannula
30. nnect the 14 pin connector of the Y Connecting Cable to the generator Connect the first introducer to the branch of the Y Connecting Cable labeled Side A Plug a grounding pad in to the generator and attach the pad to the patient Enter TransDiscal placement mode and the impedance will be displayed and a related tone will sound Once the first introducer is placed disconnect it from the Y connecting cable and repeat for the other introducer using only Side A of the cable 6 Place the introducers and probes in the patient e Prepare the patient and place the TransDiscal Introducers and Probes in the disc See Section 7 for Placement Guidelines 7 Connect probes to Pain Management Tube Kits e Pass the tubing and electrical connections on the probe out of the sterile field e Remove the caps from the two luer locks on each of the TransDiscal Probes and the Tube Kits Connect the luer locks snugly It does not matter which probe is connected to each tube kit Maintain sterility of the tubing s inner pathway so in case water is accidentally spilled in the sterile field sterility will not be compromised Luer Lock Cap eS De n Page 16 of 53 8 Connect the probes to the Y Connecting Cable e Connect the male connectors on the TransDiscal Probes to the female connectors on the Y Connecting Cable e Connect the Y Connecting Cable to the generator if you have not already done so for impedance g
31. o the heating profile which is determined by the parameters At the beginning of the procedure the temperature is lower than body temperature because the pumps are running and cooling has begun The probe temperature will increase at the Ramp Rate until it reaches the Set Temperature The temperature will remain at the Set Temperature until the Time is complete Page 27 of 53 Effect of Parameters Ramp Rate is the rate of increase in temperature degrees Celsius of the probe electrodes per minute A slower Ramp Rate results in better control of heating larger volumes of heated tissue and more consistent temperature through the volume A faster Ramp Rate results in shorter procedure time In conventional non cooled RF procedures such as a z joint rhizotomy ramp rate is usually about 15 seconds This rate is much faster that what is needed with the TransDiscal system It must be understood that a slower Ramp Rate is required when heating a large volume of tissue Ramp Rate can only be changed in Advanced Settings of the generator Set Temperature is the maximum temperature of the probe s electrode surface The temperature will increase at the Ramp Rate until it reaches the Set Temperature which is then maintained Due to the cooling of the electrodes the Set Temperature will be 10 15 Celsius lower than the tissue a few millimeters from the electrode The level of the Set Temperature in combination with the Ramp Rate and Time will affect the
32. of tissue heated using RF is to increase the power However increasing power also has its limitations It has been demonstrated that tissue impedance the measurement of tissue resistance to alternating current decreases as the temperature increases up to 60 to 70 C further increase in temperature leads to a rapid increase in tissue impedance As tissue impedance increases at high temperatures the further flow of current becomes more difficult and harder to control The current emanating from the electrode or pole in Figure 2 travels through the body completing the circuit at another electrode or pole The second electrode also referred to as a return or passive electrode determines if the system is a monopolar or bipolar system Monopolar RF systems deliver current between an active electrode with a small surface area and a passive electrode with a large surface area Although two poles are present the term monopolar is used to describe this configuration because only the active electrode with its small surface area and corresponding high current density creates a substantial ionic heating effect Figure 3a The same amount of current that emanates from the active electrode is dispersed over the much larger surface area of the passive electrode and current density is very low This means that ionic heating is not produced around the passive electrode Bipolar System Physics A bipolar RF system contains two electrodes that have the s
33. onal text Errors 108 110 123 Error 125 Error 126 Invalid water temperature Ensure sterile water is gt 17 C and lt 34 C Improper connections Check all connections Damaged Y Cable Swap TransDiscal Y Connecting Cable Swap Probe Damaged Probe Independently swap TransDiscal Probes Damaged Probe Internal error requires repair Call Clinical Support Page 51 of 53 12 References Saberski L et al 2000 Cryoneurolysis and Radiofrequency Lesioning In Practical Management of Pain Eds Abrams et al Ch 53 Mosby O Connor JL Bloom DA William T Bovie and Electrosurgery Surgery 1996 119 4 390 6 Aranow S The use of radiofrequency power in making lesions in the brain J Neurosurg 1960 17 431 438 Gabriel C Gabriel S and E Corthout 1996 The dielectric properties of biological tissues I Literature surveys Phys Med Biol 41 2231 2249 Noe CE and Racz GB 1996 Radiofrequency In Pain Medicine Ed Raj PP ch 28 Mosby j Organ LW 1976 1977 Electrophysiologic principles of radiofrequency lesion making Appl Neurophysiol 39 69 76 f Borggrefe M Hindricks G Haverkamp W Breithardt G 1990 Catheter ablation using radiofrequency energy Clin Cardiol 13 127 131 8 Dadd JS Ryan TP Platt R 1996 Tissue impedance as a function of temperature and time Biomed Sci Instrum 32 205 14 Goldberg SN Gazelle GS Dawson SL Rittman WJ Muel
34. oscopy views to make sure the probes are still in a desirable position in the disc of BAYLIS MEDICAL COMPANY INC ys MEASUREMENTS SETTINGS Ej ma Sas SA 460 o paree 12 301 451 33 ee A l ON TIME min 15 00 TRANSDISCAL DATA 100 Figure 11 Generator graph showing a small blip is okay Page 30 of 53 An example of a graph that indicates a poor procedure is shown in Figure 12 The PERIPHERAL TEMP is increasing faster than the TRANSDISCAL TEMP and the lines are not smooth but jagged This indicates that the edge of the disc is heating up more than the inside of the disc There may be a heat sink in the disc such as a severely degenerated disc containing blood The power line is also jagged and Is increasing to 12 watts in only two minutes Stop the procedure if this scenario is seen gC BAYLIS MEDICAL COMPANY INC MEASUREMENTS SETTINGS SSS TRansDiscaLE PERIPHERAL 2 09 3 l r 10 bea 460 5 TRANSDISCAL DATA ON TIME min 100 aE 15 00 20 Figure 12 Generator graph of a poor procedure Page 31 of 53 10 Post Procedural Care Overview This section discusses what the patient should do after the procedure In this section you will learn e Patient discharge instructions e Activity guidelines e Physical therapy The patient s physical activity and care after their procedu
35. our thigh Hold 30 secs relax Repeat 5 times Both legs 2x day Lying on your back with a cushion under your head Put a towel or belt under the sale of your foot and hold onto the belt with both hands Lift your leg straight up Pull the belt gently point your toe to stretch the back of your thigh Hold 30 secs then relax Repeat 5 times Both legs 2x day START POSITION With your corset on lie on back with legs bent and feet together ACTION Pull stomach up and in Do not allow back to flatten NS ao Hold for 10 secs Repeat 10 times 2xiday Phrao a Lid Built on Taols RG Personal Exercise Program WW Page 36 of 53 TD Protos Lis PrpmoToos We Built on Tools AiG Lying on your back or sitting Bend and straighten your ankles briskly If you keep your knees straight during the exercise you will stretch your calf muscles Repeat 30 times 2x day Sit on a chair with good posture Pull your toes up tighten your thigh muscle and straighten your knes Hold approx 5 secs and slowly relax your leg Repeat 10 times Both legs 2xday Stand on a step with ONE heel over the edge Hold on toa Support i Let the weight of your body stratch your heels towards the floor keeping your knee siraight Hold 30 sec Repeat 5 times Both lags 2xiday Stand leaning with your back against a wall and your feet about 2 feet from the wall Slowly slide down the wall until your hips and knees are at
36. owering is permitted avoid soaking in the bathtub Eat a regular diet You may remove bandages the following day You may use an ice pack today and warm moist heat tomorrow if you experience discomfort when the local anesthetic wears off Seek immediate medical attention if f you experience severe headache or severe pain at the injection site with swelling and redness lf your pain increases or if you experience fever or chills lf you experience shortness of breath or chest pain Activity guidelines after the procedure Rest for 1 3 days after the procedure in a comfortable position i e lying down or reclining Limit sitting or walking to 10 20 minutes at a time Return to work lf your work is sedentary you may return in roughly one week For other jobs especially physically demanding jobs the decision will be made by your physician Driving Do not drive for the first 1 5 days and driving should be limited to 20 30 minutes for the first 6 weeks Make sure your vehicle has good lumbar support you may need a pillow As a passenger recline the seat and try to limit driving duration to less than 45 minutes for the first 6 weeks It is okay to recline or lie down in the back seat and be driven home the day of your procedure Sitting Limit to 30 45 minutes at a time for the first 6 weeks in a chair with good support Avoid sitting on soft couches or chairs Stand and walk about for short breaks between sitting periods
37. pproach should be between 20 to 30 from the sagittal plane The same angle as the pedicle is appropriate and allows the pedicle to be used as a landmark If a smaller angle is used the electrodes may end up too close to the lateral surface of the disc If a larger angle is used the electrodes may be very close together and too far from the lateral edges of the disc and heating of the lateral regions may be insufficient e The introducer should pass lateral to the superior articular process but it should not make contact This is to prevent injury of the zygapophaseal joint e The electrodes should be placed at approximately the center of the disc height Ensuring the electrode is far away from either endplate increases the safety of the procedure With the probe fully inserted into the introducer the distal opening of the introducer should be at the edge of the disc to ensure proper depth in to the annulus YN lt The introducer passes lateral to the SAP without injuring the z joint Figure 9 TransDiscal Probe placement guidelines Page 19 of 53 Lumbar Anatomy Fluoroscopic Image This is an oblique view of a lumbar spine showing an outline of the Scotty Dog and some of the boney landmarks Scotty Dog Photograph Compare the above image with this photograph of a spine model This photograph is taken at the same angle as the fluoroscopic image and also has an outline of the Scotty Dog
38. r diabetes other surgery within last 3 months Page 12 of 53 6 Setup Instructions Overview The following section outlines the procedure for setting up the TransDiscal System We have provided two set up guides e Quick Start Equipment Set Up designed for users who have previously handled the equipment Detailed Equipment Set Up designed for users who are using the system for the first time Equipment Set Up Diagram The TransDiscal System consists of Reusable Equipment 1 Pain Management Generator TD 2 Pain Management Pump Unit 3 Pump Connecting Cable 4 TransDiscal Y Connecting Cable Disposable Kit 5 two Pain Management Tube Kits 6 two TransDiscal Probes 7 two TransDiscal Introducers Quick Start Equipment Set Up 1 Connect the Generator to the Pain Management Pump Unit 2 Plug in the Generator and turn it on 3 Insert Pain Management Tube Kits into the Pain Management Pump Unit 4 Fill the burettes with sterile water 5 Optional Connect the introducers to the generator for impedance guided placement 6 Place the introducers and probes in the patient 7 Connect probes to Pain Management Tube Kits 8 Connect the probes to the Y Connecting Cable Figure 6 TransDiscal set up Page 13 of 53 Detailed Equipment Set Up 1 Connect the Generator to the Pain Management Pump Unit e Connect the male connector of the Pain Management Pump Connector Cable to the generator e Conne
39. ransDiscal System In this section you will e Learn how to identify potential problems with system components e Become familiar with the Generator Error and Fault Codes that may appear during a TransDiscal procedure Trouble Shooting TransDiscal RF System Components Each component of the TransDiscal System excluding the BMC RF Generator has a trouble shooting table in their Instructions for Use to assist the user in diagnosing potential problems The BMC RF Generator has a section dedicated to the Error and Fault codes that may be seen during a TransDiscal procedure Page 41 of 53 TransDiscal RF System Component Trouble shooting Troubleshooting during equipment set up Damage to the TransDiscal Introducer Visually inspect the packaging before use The sterile pouch should not have any packaging of a sterile TransDiscal Probe and Pain holes device Management Tube Kit Discard the device if packaging has been compromised Obvious visual damage TransDiscal Y Connecting Visually inspect the products for any damage Look for damage such as cuts to any product Cable Pain Management Pump cracks breaks and bends Unit TransDiscal Probes TransDiscal Introducers Pain Do not use damaged equipment Management Tube Kits Electrical connectors do TransDiscal Probe and not connect TransDiscal Y Connecting Cable Check that the connector s keys are lined up in the proper orientation Turn the connector until it slides in the mati
40. ransac Biomed Eng 50 4 493 499 Page 52 of 53 16 Wong WS VanderBrink BA Riley RE Pomeranz M Link MS Homoud MK Estes III NAM Wang PJ 2000 Effect of saline irrigation flow rate on temperature profile during cooled radiofrequency ablation J Interven Card Electrophysiol 4 321 326 Page 53 of 53
41. re is crucial to their recovery A patient who has had chronic low back pain for some time will have weak back muscles and incorrect habits of back care such as posture and lifting The patient will need to gradually increase the strength of their stabilizing muscles and learn proper posture Although pain may be greatly diminished or eliminated after the procedure the patient must gradually increase activity and strength to allow muscles to develop properly allow for the disc to recover from the procedure and avoid injuring the disc or straining back muscles The patient will be discharged from the clinic and instructed to avoid strenuous activity for a period of six weeks A brace is necessary for 6 8 weeks and physical activity must be increased gradually A recommended therapy program provided by Physical Therapist Marleen Dunfee is included The program is directed at gradually increasing activity and practicing proper mechanics of posture and lifting This physical therapy program is recommended as a guideline and the physician can make modifications at their discretion according to the patient s physical condition and ability Page 32 of 53 The following instructions can be given to the patient at the discretion of the physician Discharge instructions for the day of the procedure Do not drive or operate machinery Do not engage in any strenuous activity Wear the brace all the time for 6 8 weeks except when showering or in bed Sh
42. right angles Return to starting poseidon At your lowest position your knees should not go beyond your toes Repeat 10 times Today Walk daily beginning at the end of the first week for approximately 20 minutes Increase to 20 minutes twice per day If tolerated progressively increase to 1 houra day by the end of the fourth week If back or leg symptoms increase at any point decrease the duration of walking Personal Exercise Program 2i2 Page 37 of 53 Week 6 8 Pryan Toots Lii Peysia Tools Lid Peysio Trois Lid PipucTeala Lis Built an Toole RG START POSITION Lie on the back with one leg bent and the heel beside the straight knee The back should be flat and the pelvis should be level without any twist ACTION Pull your belly button towards your spine to keep the back fiat and slowly lat the bent knee lower out ta the side Do not let the pelvis twist or rotate at all ONLY move the leg as far as the flat back and level pelvis allow Slowly return to the start postion maintaining control of the pelvis during the retumi Repeat 10 times on each leg 1x day adpt Sahrmann PhD PT Lying on back with knees bent up and feet flat on floor Lift your bottom off the floor as high as possible Squeeze your bullock at the top and hold for 5 seconds Retum to starting positon Repeat 15 times 1xiday Lying on your back with your fingers just behind your ears and elbows out Tighten your stomach mu
43. s the stable back allows Hold for 5 seconds then lower slowly Altemate R leg then L leg Repeat 70 times 1x day Practice sitting upright without using a back support Lift up from your chest and tuck in your chin Hold for 1 minute Relax and repeat 5 times 1x day Try to make this a habit throughout your day to sit up es straight as you can The Partial Squat Lift Without Support Placa a small item lt 10 lbs on a surface about 3 4 feet from the floor Keep your head and chest up back slightly arched and feet comfortably spread apart as you squat down Keep the weight close and stand up straight Repeat 10x 1x day Try to make this a habit when lifting anything from a lower surface Personal Exercise Program a3 Page 39 of 53 The Deep Squat Lift Place a small item lt 10lbs on the floor Keep your head and chest up back slightly arched and feet shoulder width apart as you squat down to the foor Keep the weight close to your body and straighten up AS you Straighten up keep your back straight Keeping your back straight lower the Hem back down to the floor Repeat 10x 1xfday Try to make this a habit when lifting anything from the floor The mnis Groep beg a T a E aa N aU Guat on Tooled RG Personal Exercse Program a3 Home exercise program provided by Physical Therapist Marleen Dunfee Page 40 of 53 11 Troubleshooting Overview In this section you will learn how to trouble shoot the T
44. scles and lift your head and shoulders off the floor Repeat 10 times Iwday Lying with your knees bent and feet on the floor Lift your knees towards your chest Place your hands behind both knees and draw them towards your chest lf needed you can use a belt or towel behind your knees to help pull Repeat 10 times Today Personal Exercise Program 13 Page 38 of 53 Pre Tccle Lad B phoan Lid Phos Le Physa Lid START POSITION Lie face down with the hands positioned as if to start a push up ACTION Slowly push up through the hands letting the back relax into an arched position Do not let the pelvis lift Let your back and buttock relax Repeat 2 sets of 10 times 1x day START POSITION Lie face down ACTION Squeeze both buttocks to stabilise the pelvis and held this contraction Slowly lift the head and shoulders leading with the upper back ONLY lift the trunk as far as is possible with the feat remaining in contact with the floor Do not strain the arched position Hold for 3 secs Repeat 2 sets of 5 times 1x day START POSITION On hands and knees with the knees under the hips and the back relaxed in a neutral position ACTION Pull belly button toward spine without flattening your spine Hold your abdominals tight and slowly straighten the hip and knee to lift the leg out behind you Contract the buttocks slightly during the leg lift Do mat let the back arch or twist ONLY lift as far a
45. temperature throughout the tissue Set Temperature can be changed at any time before or during the RF delivery Time is the duration of radiofrequency energy delivery including the temperature ramp up and plateau A longer Time will allow a greater volume of tissue to be heated until thermal equilibrium is reached The optimum Time is long enough for adequate volume heating without excessive procedure time Time can be changed at any time before or during the RF delivery Suggested Parameters The suggested parameters used for treating a patient with the TransDiscal System are Set Temperature 45 C Ramp Rate 2 0 C min Time 15 minutes These parameters were tested and scrutinized through a series of cadaver experiments The experiments were designed to map temperatures in the disc and in the surrounding neural structures to ensure that heat was applied in a manner suitable for both efficacy and safety during treatment For practical use set the Advanced Settings on the generator as follows Peripheral Disc Warning Temp 33 C Ramp Rate 2 C min Show Peripheral Disc Temp MAX Graph Power YES Number of Probes 2 Page 28 of 53 9 Generator Graphs during Treatment Overview This section shows images of generator screens to explain what a typical good procedure looks like compared to an abnormal procedure In this section you will learn e Appearance of a typical procedure graph e Appearance of an
46. th an electrode a k a active tip on the end is inserted through each introducer and into contralateral sides of the posterior intervertebral disc Radiofrequency RF energy is delivered from and concentrated around and between the two electrodes The electrodes are internally cooled with circulating water RF energy heats the tissue and the cooling moderates the heating in close proximity to the electrodes This combination creates an ideal heating profile across the posterior disc without excessive heating A physician using this equipment must be familiar with lumbar spine anatomy image guided spine procedures and intervertebral disc pathology Important Message This guide does not replace the information in the Instructions for Use provided with the components of the TransDiscal System The Instructions for Use includes important information such as warnings precautions contraindications and trouble shooting The Instructions for Use for each component must be read prior to use Page 2 of 53 3 Physics of the TransDiscal System Overview This section briefly explains how the TransDiscal System heats disc tissue In this section you will learn The reason why high frequency alternating current is used to heat tissue The reason why a bipolar electrode set up is used during the procedure The reason why the TransDiscal Probes are internally cooled How the physics of the complete TransDiscal System work together to thermally
47. treat the intervertebral disc Direct Current amp Alternate Current Electric current refers to the amount of charge that passes through a surface per measure of time At an atomic level current is the flow of electrons A current that moves in the same direction around a circuit is referred to as Direct Current DC A current whose direction alternates continuously back and forth is referred to as Alternating Current AC See Figure 1 The number of times that the current alternates back and forth in a second is known as frequency Frequency is measured in Hertz For example 60 Hertz means that the current alternates back and forth 60 times per second Current Current Time Time Direct Current DC Alternate Current AC Figure 1 Direct Current DC and Alternate Current AC signal amplitudes Resistive Heating with DC In order to understand resistive heating you must first understand conductance Electrical conductance is the property of a material that determines the ability of current to flow through it and is based on the availability of loose electrons in the material Resistance is the opposite of conductance Copper wire for instance has high conductance and is a good conductor while rubber has low conductance and is a very poor conductor Since rubber is a poor conductor this means that it is a good resistor In a resistor as current passes through the material energy is used The harder it is to pass current through
48. uided placement It does not matter which side of the Y Connecting Cable each probe is connected to Now the equipment set up is complete Page 17 of 53 Schematic Diagrams of the TransDiscal System Set Up PAIN MAMAGEMENT PUMP CONMECTING CABLE TRANS DISCAL 5 PROBE CE TRANS DISCAL INTRODUCER PAIN MANAGEMENT TRANSOISCAL Y CONNECTING CABLE a TRANS DISCAL INTRODUCER TURE KIT TRANS DISCAL PROBE Figure 7 Schematic diagram showing setup for treatment mode GENERATOR PAIN MANAGEMENT TRANSDISCAL Y CONNECTING CABLE TRANSOISL AL INTRODUCER GROUNDING PAD Figure 8 Schematic showing setup for placement mode ma CC LZ OF CABLE STTLET Page 18 of 53 7 Placement Guidelines Overview This section describes the positioning of the introducers and probes within the disc In this section you will learn e The general safety guidelines for placement e Brief lumbar anatomy with fluoroscopic and photographic images e Step by step placement technique General Safety Guidelines For safe and effective tissue heating and safe anatomical access abide by the following guidelines e The electrodes should be placed such that the beginning of the electrode indicated by a dark band on fluoroscopy is at least 5 mm from the disc s outer surface Proper depth can be assured if the distal end of the introducer is at the edge of the disc and the probe is fully inserted into the introducer e The angle of a
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