SPINE. Bipolar Radio Frequency Plasma Surgical Electrodes Radio Frequency Plasma Surgical Systems

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Lisa Eileen Paul
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Plasma Surgical Systems Manufacturing Factory: F6, Building G21, North of Xinyang Road, East of Koutai Road, China Medical City Zone, Taizhou, Jiangsu 225316, China Tel:

1 SPINE Marketing Center: Room#905 Building #1, Funian Square, Tianfu No.3 Street, Hi-Tech District, Chengdu , Sichuan, China Tel: Fax: Bipolar Radio Frequency Plasma Surgical Electrodes Radio Frequency Plasma Surgical Systems Manufacturing Factory: F6, Building G21, North of Xinyang Road, East of Koutai Road, China Medical City Zone, Taizhou, Jiangsu , China Tel: Fax: Chengdu & Taizhou Information included herein is indicative only. Actual products you receive may differ. Professional Supplier of Bipolar Radio Frequency Plasma Surgical Electrodes BS-SPINE-C File V

2 Specialized in Minimally-invasive Radio Frequency Plasma Technology for Spine Surgery

RF Ablation Electrode Bipolar RF Ablation Electrode provides an innovative and effective surgical procedure with excellent clinical outcome.

An innovative and minimally-invasive surgical solution for discogenic diseases.

Decompression Plasma Ablation Electrode Nucleus-plasty Designed for cervical and lumbar disc herniation.

disc on the nerves, artery and nucleus of the surrounding tissues.

Intradiscal Decompression Ordering Code: A301E3 A302E5 A perfect combination for spine microsurgery: RF Ablation Electrode & Transforaminal

endoscopic visualization of RF ablation, controllable nucleus ablation, nucleus vaporazation, hemostasis and annulus modulation.

Tissue Shrinkage and Coagulation Annulus Shrinkage Decompression Finished Minimally-invasive approach to achieve disc decompression.

Precise disc compression of inter-vertebral disc. Precise tissue removal with minimal damage to surrounding tissue and effective Disc Compression.

3 RF Ablation Electrode Bipolar RF Ablation Electrode provides an innovative and effective surgical procedure with excellent clinical outcome. Designed for contained disc herniations disectomies. A surgical procedure of safe, rapid and effective performances. An innovative and minimally-invasive surgical solution for discogenic diseases. Minimally-invasive Shorter Procedure Time Reduced Tissue Damage Less Patient Pain Faster Recovery Nucleus Ablation Soft Tissue Ablation, Nucleus Decompression Plasma Ablation Electrode Nucleus-plasty Designed for cervical and lumbar disc herniation. Through plasma energy of Nucleus vaporization and shrinkage to achieve disc decompression and effectively release the compression from herniated disc on the nerves, artery and nucleus of the surrounding tissues. Thus, the relevant symptoms is removed or relieved which effectively relieve the compression on nerves meanwhile keeping annulus intact. Intradiscal Decompression Ordering Code: A301E3 A302E5 A perfect combination for spine microsurgery: RF Ablation Electrode & Transforaminal Endoscope Grasp Tissues by Nucleus Clamp The surgical approach by using particular RF Ablation Electrode under transforaminal endoscope involves the endoscopic visualization of RF ablation, controllable nucleus ablation, nucleus vaporazation, hemostasis and annulus modulation. Advantages: Outpatient surgery Smaller incision than traditional surgery Local anesthesia Precise access to target tissues Annulus Modulation Soft Tissue Shrinkage and Coagulation Annulus Shrinkage Decompression Finished Minimally-invasive approach to achieve disc decompression. Out-patient procedure. Vaporization of nucleus tissues in a controlled low temperature. Receive tactile feedback from patients. Precise disc compression of inter-vertebral disc. Precise tissue removal with minimal damage to surrounding tissue and effective Disc Compression. Quick relief of back pain, improving life quality and early return to normal activities. Local anesthesia, standard discography approach, easy and simple operation. Minimally-invasive and safe procedure, with low risk and little complications. Excellent surgical outcomes. Ordering Code: A301A1 A301A2 Procedure: Ablation and Decompression of Cervical Disc Herniation Ordering Code: A302A1 A302A2 A302A3 A302A4 Procedure Ablation and Decompression of Lumbar Disc Herniation

Study of Effectiveness of Nucleus-plasty by Plasma Ablation Effective Decompression Effective decompression is achieved by

The suitable number of ablative channel is confirmed according to experimental data, to achieve the effective and safe disc

Low-temperature Ablation Temperature by plasma ablation is controlled within the scope of the 70 degrees Celsius, making the

50 Thermogram by Plasma Temperature Change C Nucleus Volume Reduction / Ablation by Channeling Numbers 1 2 3 4 5 6 7 8 9 10 11

Number 51501 2 3 4 51Thermogram by Laser Thermal Map of Porcine Inter-vertebral Disc 0Distance to Electrode Tip (mm) Minimal

No mechanical damage or thermal damage or necrosis is caused on the key spine structure, nucleus, annulus fibrosus, end plate,

Electrode of 1 mm diameter creates channels of only 2mm diameter within the disc nucleus, with surrounding tissues intact.

thermal damage caused when plasma electrode ablates tissues. That is especially important to the safety of neck ablation.

The approach of plasma ablation obviously improves the internal chemical environment caused by Inter-vertebral disc

Different from the traditional way which creates tissue necrosis by high temperature heat shrinkage technology, the approach

This function significantly improves the problems caused by fast Inter-vertebral disc degeneration and rapid loss of disc

It s found that the Inter-vertebral disc treated by RF plasma surgical system is the same in morphology and biological

And the change of cytokines index after decompression surgery by plasma is consistent with the biochemical mechanism of

IL - 1 Interleukin -1 shows a significant decrease after ablation. The factor and tissue degeneration are positively related.

The edges of ablation channels seem very clean and no necrosis found, with fiber annulus and end plate intact.

in nucleus Density 16 14 12 10 8 6 4 2 0 Collagenous fibrils of annulus fibrosus Biochemical Index of Inter-vertebral Disc

Effect by Low-Temperature Plasma Radix 6Weeks 12Weeks Time Treatment for Cervical Spondylosis (Neck and Shoulder Pain) by

extended slightly, position the target disease spaces by Kirschner wire under Fluoroscopy, and mark the position.

4 Study of Effectiveness of Nucleus-plasty by Plasma Ablation Effective Decompression Effective decompression is achieved by plasma ablation of disc nucleus. The suitable number of ablative channel is confirmed according to experimental data, to achieve the effective and safe disc decompression by plasma ablation. The procedure achieves quick drop of intradiscal pressure. Low-temperature Ablation Temperature by plasma ablation is controlled within the scope of the 70 degrees Celsius, making the ablation temperature controllable through the whole surgery process. Reduction Volume PSI Thermogram by Plasma Temperature Change C Nucleus Volume Reduction / Ablation by Channeling Numbers Channeling Number Disc Pressure of Nucleus-plasty Non-severe Degeneration Channeling Number Thermogram by Laser Thermal Map of Porcine Inter-vertebral Disc 0Distance to Electrode Tip (mm) Minimal Tissue Damage, Safe & Controllable Plasma ablation achieves controllable and safe nucleus reduction. No mechanical damage or thermal damage or necrosis is caused on the key spine structure, nucleus, annulus fibrosus, end plate, spinal cord and nerve root of the targeted surrounding tissues. Electrode of 1 mm diameter creates channels of only 2mm diameter within the disc nucleus, with surrounding tissues intact. Experiments show that the plasma surgical electrodes have effective tissue-ablation function, meanwhile with no obvious thermal damage. Surrounding tissues of the ablation channel within the disc nucleus is kept intact, which shows that there is no obvious thermal damage caused when plasma electrode ablates tissues. That is especially important to the safety of neck ablation. Nucleus 2mm Dense Nucleus Ablation Channel Dense Nucleus Tissues Regain Vitality After Ablation. Effective Pain Relief. The approach of plasma ablation obviously improves the internal chemical environment caused by Inter-vertebral disc degeneration and induces synthesis of repair factors, which is advantageous to the local repair. Different from the traditional way which creates tissue necrosis by high temperature heat shrinkage technology, the approach of plasma ablation can control temperature at the electrode tip within 50 to 60 degrees for shrinkage function. This function significantly improves the problems caused by fast Inter-vertebral disc degeneration and rapid loss of disc height of traditional surgery. It s found that the Inter-vertebral disc treated by RF plasma surgical system is the same in morphology and biological mechanics as that of the untreated disc. And the change of cytokines index after decompression surgery by plasma is consistent with the biochemical mechanism of analgesia. So it s concluded that plasma nucleus-plasty might initiate the repair mechanism of Inter-vertebral disc. IL - 1 Interleukin -1 shows a significant decrease after ablation. The factor and tissue degeneration are positively related. IL - 8 Interleukin - 8 shows a significant increase after ablation.the factor and tissue repair are positively related. The edges of ablation channels seem very clean and no necrosis found, with fiber annulus and end plate intact. Collagen nerve and spinal cord tissue are intact; Nerve root close to the ablation area has no sign of necrosis and no damage is found. (magnified by 200 times) Micrograph shows the dense nucleus around surgical area is normal Type II Collagen and proteoglycan in nucleus Density Collagenous fibrils of annulus fibrosus Biochemical Index of Inter-vertebral Disc 1L-1 Degeneration Trend 1L-1 Nucleus-plasty Effect by Low-Temperature Plasma 1L-8 Degeneration Trend 1L-8 Nucleus-plasty Effect by Low-Temperature Plasma Radix 6Weeks 12Weeks Time Treatment for Cervical Spondylosis (Neck and Shoulder Pain) by Plasma Ablation Nucleus-plasty Position Local Anesthesia Puncture Ablation Adopt supine position, make the patient s neck extended slightly, position the target disease spaces by Kirschner wire under Fluoroscopy, and mark the position. Under C-arm CT guidance, insert the needle between the arterial sheath and the viscera sheath into the center point of Inter-vertebral disc. Make sure the needle is inserted into the center point in both front and side position under fluoroscopy. Set the generator output to gear 2 (125 VRMS), step on COAG pedal for half a second to test the reaction of the patients and make sure there s no exception reaction; If any stimulus symptoms happens, the surgeon should readjust the puncture position; Step on ABLATE pedal, at the same time, repeatedly rotate electrode tip by 180 degrees for 10 ~ 15 seconds to complete an ablation process. If a second ablation at the same interval is needed, firstly remove the coupling of electrode and puncture needle end and retreat the electrode by 1 cm to make the electrode tip back into the needle, retreat the needle back by 2 ~ 3 mm, and then re-coupling electrode at the puncture needle end. To make another ablation process by using the same way as above. After ablation, remove coupling, withdraw the electrode, and pull out the needle. Coated the skin with band-aid after pulling out the needle. Neck collar fixed for a week. Patient Selection (Indications) Placement of the Electrode Patients with heavy shoulder & neck, pain with upper limbs root acid bilges, burning pain symptoms and confirmed by MRI to be corresponding herniated interval disc space with cervical spondylosis. Patients with headache, dizziness, tinnitus, vertigo and has been diagnosed without internal related diseases. Patient diagnosed to be cervical spondylosis without operative indications. Gently push the electrode in the trocar needle direction, coupling it with(rotating fixation) the needle end, and confirm the electrode position under fluoroscope. Attention After trocar positioned, pull out the stylet For patients diagnosed under MRI to be multiple segmental cervical Inter-vertebral disc herniation, doctors should carefully sort out the major interval space corresponding to symptoms and objects to avoid too much segment operation at a time. For patients who mainly have arm numbness and urge to relieve numbness symptoms, doctors should select carefully.

Nucleus-plasty by Low-temperature Plasma Ablation Percutaneous Puncture Treatment for

core, and then insert in the lumber plasma electrode Equipment Key Points in Lumber

Needle/Trocar Needle Prone Position Location Using Kirschner wire to locate lesion

Choosing Puncture Point Position The point at 8-10CM away from the spine mid-line and

2) When the mark on the back of electrode sheath meets the end of the puncture needle,

It s the proximal position of the ablation procedure.

needle to ensure that the electrode working part has no contact with puncture needle in

3) Push the electrode until it stops, to make it reach the end on the other side of the

to the end of the puncture needle. This point is the distal ablation point.

Under guidance of CT, to insert the special puncture needle into inter-verterbral disc

space, where it s called safe tri-angle area.

Ablation Local Anesthesia Puncture Location a) Key Point of Puncture Safe Tri-angle Area

area with superior margin of next vertebral and its anterolateral surface of joint facet.

Entopic needle is positioned at medialis edge of vertebral pedicle Parallel Lateral

set the generator to Gear 2 (125Vrms), step on the ABLATE pedal of the foot switch, push

the Coagulation pedal, meanwhile retreat the electrode by the same route at the speed of

Attention Operate ablation procedure in another 5 directions: 2 o clock, 4 o clock, 6 o

Keep the puncture needle parallel with inter-vertebral space.

If any radiating pain happens at lower extremities, stop the puncture immediately, change

5 Nucleus-plasty by Low-temperature Plasma Ablation Percutaneous Puncture Treatment for Herniated Disc b) Key Points of Plasma Surgical Electrode Puncture 1 Draw out the needle core, and then insert in the lumber plasma electrode Equipment Key Points in Lumber Surgical Operations C-arm CT Plasma Surgical System Plasma Electrode Puncture Needle/Trocar Needle Prone Position Location Using Kirschner wire to locate lesion interval under fluoroscope in prone position, and mark it on body surface. Choosing Puncture Point Position The point at 8-10CM away from the spine mid-line and parallel with Inter-vertebral space. 2) When the mark on the back of electrode sheath meets the end of the puncture needle, the electrode tip should stick out the puncture needle by 5mm. It s the proximal position of the ablation procedure. The electrode tip sticking out the puncture needle is longer by 5mm than the puncture needle to ensure that the electrode working part has no contact with puncture needle in the nucleus. 3) Push the electrode until it stops, to make it reach the end on the other side of the annulus fibrosu and to confirm the position under fluoroscope, and move the spring clamp to the end of the puncture needle. This point is the distal ablation point. 4 Retreat the electrode to the proximal point, and start the ablation operation. Under guidance of CT, to insert the special puncture needle into inter-verterbral disc through the point of 8-10CM away from the spine-midline and parallel with inter-vertebral space, where it s called safe tri-angle area. Keep the needle at a degree angle with skin. Ablation Local Anesthesia Puncture Location a) Key Point of Puncture Safe Tri-angle Area Lumber nerve root stick out from the Inter-vertebral foramen, forming a safe tri-angle area with superior margin of next vertebral and its anterolateral surface of joint facet. Annulus fibrosus of Inter-vertebral disc is located in this area on which there is no bone structure. Puncture needle tip should be located at the border of annulus fibrosus and nucleus Entopic needle is positioned at medialis edge of vertebral pedicle Parallel Lateral Needle is positioned at retral 1/3-1/4 of vertebral pedicle Under monitor of C-arm CT, set the generator to Gear 2 (125Vrms), step on the ABLATE pedal of the foot switch, push the electrode slowly to the distal point for decompression operation, and then step on the Coagulation pedal, meanwhile retreat the electrode by the same route at the speed of 5mm/Sec, thus the ablation and coagulation in one direction is finished. Attention Operate ablation procedure in another 5 directions: 2 o clock, 4 o clock, 6 o clock, 8 o clock and 10 o clock. Keep the puncture needle parallel with inter-vertebral space. Patients may feel lumber pain when puncture needle reaches the annulus fibrosus. If any radiating pain happens at lower extremities, stop the puncture immediately, change the puncture position and re-puncture. Repeated and multi-times puncture at L5-S1 is not recommended. Waist soreness or mild pain is normal reaction during surgery. Patient Selection(Indications) Patients under age of 50, with course of disease less than 5 years. No effect or little effect from conservative treatment, and not open to open surgery. Patients suffering from lumbago from long-time sitting or standing with radiating pain of hip or low extremities, with main symptoms of nerve root stimulation related to Inter-vertebral disc pressure. Height of Inter-vertebral disc > 75%. MRI: diagnosis to be IDD DDD contained herniated disc. Discography Positive.

How It Works ABLATE The Radio Frequency energy flows through active electrode and return electrode, and by the conductive saline solution it generates precisely focused plasma sheath around the

The generated energy is powerful enough to break the organic molecular bonds within the tissue, and make the tissue rapidly dissolved into molecular and atoms level at a relatively low temperature of

ARS 700 Radio Frequency Plasma Surgical Systems COAGULATE When RF energy acts on tissue (including blood), around the electrode tip it generates Joule heat and electromagnetic wave effect which

The surgical process by plasma ablation creates well-distributed coagulative necrosis for efficient hemostasis while preserving the mucosa and fibrous tissue.

Different from the past thermal coagulation by high temperature, plasma technology can make the working temperature controlled at 40-70 C, and coagulate helical structure of collagen molecules

COAG for coagulation and hemostasis activated at Blue control panel and Blue foot pedal.

It uses a controlled, non-heat driven process in which bipolar radiofrequency (RF) energy excites the electrolytes in a conductive medium, usually saline solution, to create a precisely focused and

6 How It Works ABLATE The Radio Frequency energy flows through active electrode and return electrode, and by the conductive saline solution it generates precisely focused plasma sheath around the electrodes. The plasma sheath consists of massive charged particles which can generate sufficient energy of strong oxidizing when accelerated by the electric field. The generated energy is powerful enough to break the organic molecular bonds within the tissue, and make the tissue rapidly dissolved into molecular and atoms level at a relatively low temperature of C. The device provides rapid and efficient ablation and resection capabilities of soft tissues in a relatively low temperature. ARS 700 Radio Frequency Plasma Surgical Systems COAGULATE When RF energy acts on tissue (including blood), around the electrode tip it generates Joule heat and electromagnetic wave effect which providing an immediate coagulation of tissue protein and sealing of small blood vessels, thus coagulation and hemostasis capabilities of target tissues are realized. The surgical process by plasma ablation creates well-distributed coagulative necrosis for efficient hemostasis while preserving the mucosa and fibrous tissue. Compared to that of conventional surgical methods, its post-operative recovery is improved. Different from the past thermal coagulation by high temperature, plasma technology can make the working temperature controlled at C, and coagulate helical structure of collagen molecules meanwhile preserving the cells vitality. Excellent Performance Systematic Working Mode Two working modes: ABLATE for resection and ablation activated at Yellow control panel and Yellow foot pedal. COAG for coagulation and hemostasis activated at Blue control panel and Blue foot pedal. Structure Shrinkage Temperature Control Technology The surgical process by plasma technology is performed at controlled C. It uses a controlled, non-heat driven process in which bipolar radiofrequency (RF) energy excites the electrolytes in a conductive medium, usually saline solution, to create a precisely focused and charged plasma gas. The energized particles in the plasma have sufficient energy to break the organic molecular bonds within tissue, causing tissue to dissolve at relatively low temperatures of C. Radiofrequency current does not pass directly through tissues, causing minimal tissue thermal effect. By temperature control technology, it automatically optimizes output value according to the plasma layer status around the electrode tip and the target tissue feature, by which electrode can provide a stable and efficient capabilities while keeping the lowest working temperature. Bipolar and Multi-polar Technology Various bipolar and multipolar electrode designs are available. Around the electrode tip, sufficient and stable plasma layer is generated for rapid resection, ablation, coagulation and hemostasis of soft tissues. Precise Working Control System Standard Inter-vertebral disc radiography access, particular plasma surgical electrode with diameter less than 1mm. Gasify nucleus pulposus tissue within the range of 70 degree Celsius, with energy penetration depth controlled within 20um, forming an effective Inter-vertebral disc decompression and nucleus-plasty. Integrated Function In one versatile single-use electrode, it provides ABLATE for resection and ablation, and COAG for coagulation and hemostasis. Intelligent Control System Designed with automatic identification of electrode, foot switch and power cord, displayed respectively on the device control panel, and automatic default power output value for different electrode designs. Automatic Protection The electrical circuit system in ARS 800 controller can constantly monitor power output and automatically suspend power output when there is instantaneous peak current. For example, the controller will automatically suspend radio frequency output when electrode contacts or is close to metal, and automatically resumes work after electrode has returned to a proper distance. Foot Switch The water-proof, pressure-resistant and convenient foot control has two working modes of ABLATE and COAG, each identified in different colors and working sounds.

A Patient s Guide to Artificial Cervical Disc Replacement

A Patient s Guide to Artificial Cervical Disc Replacement Each year, hundreds of thousands of adults are diagnosed with Cervical Disc Degeneration, an upper spine condition that can cause pain and numbness