Advanced Energy. TRANSCOLLATION Technology and the AQUAMANTYS System

Transcription

1 Advanced Energy TRANSCOLLATION Technology and the AQUAMANTYS System

2 Introduction to Electrosurgery 2 MDT Confidential

3 Cautery Electrosurgery Cautery Electrocautery Electrosurgery 3 MDT Confidential

4 Electrosurgery 101 Electrocautery uses electric current to heat an object with the intent to burn tissue. In electrosurgery, the current of energy is driven through the tissue to cut or coagulate. 4 MDT Confidential

5 William T. Bovie Developed by William T. Bovie Physicist at Harvard Worked with Dr. Harvey Cushing, a distinguished neurosurgeon at Peter Brent Brigham Hospital in Boston 1926 The term bovie is often still used generically as a noun to refer to an electrosurgical apparatus or even as a verb to describe the act of performing electrosurgery. 5 MDT Confidential

6 Monopolar Electrosurgery 6 MDT Confidential

7 Monopolar Electrosurgery In monopolar electrosurgery, the active electrode is in the surgical site. The patient return electrode is somewhere else on the patient s body. The current passes through the patient as it completes the circuit from the active electrode to the patient return electrode. Patient Return Electrode (PRE) 7 MDT Confidential

8 REM = Return Electrode Monitoring, a technology developed to actively monitor the pad for greater safety 8 MDT Confidential

9 Electrosurgical Generators Valleylab Erbe Bovie Conmed 9 MDT Confidential

10 BOVIE ~490 KHz House Current (60 Hz) Neuro-Stimulation Ceases (100 KHz) RF (30 KHz 300 GHz) FREQUENCY SPECTRUM 10 MDT Confidential

11 Monopolar Modes of Operation Cut Coagulate (Coag) Blend 11 MDT Confidential

12 Cut, Coag, Blend CUT is a continuous current Low voltage 100% on / 0% off High heat, vaporization BLEND is the combination of cut and coag COAG is pulsed current High voltage 6% on / 94% off Low heat, less vaporization Fulguration Figure 2.7. Photo of steak meat cut with cut, blend or coag mode 12 MDT Confidential

13 Cellular Process Cutting Generator produces radiofrequency (RF) energy RF energy heats water within cells causing them to boil Excessive pressure is built up due to transition of water from liquid state to the gaseous state (gas occupies a space ~1600 times that of a liquid) Pressure causes the cells to dehydrate or to burst 13 MDT Confidential

14 Variables Impacting Tissue Effect Electrode Shape & Size Gap Waveform Surgical Technique Presence of Saline Type of Tissue 14 MDT Confidential

15 Bipolar Electrosurgery 15 MDT Confidential

16 Bipolar Electrosurgery In bipolar electrosurgery, both the active electrode and return electrode functions are performed at the site of surgery. Only the tissue [between the electrodes] is included in the electrical circuit; therefore, no patient return electrode is needed. 16 MDT Confidential

17 Characteristics of Bipolar Electrosurgery o Two active electrodes Current flows from one device electrode, through tissue, to the other device electrode o Electrode size & shape Smaller surface area and sharper edges vs. larger and smoother surface area 17 MDT Confidential

18 Bipolar Forceps Coaption Squeezing vessels compression and heat For vessels >1mm in diameter Malis Forceps Pin-Point Small blood vessel sealed in non-coapted tissue Bayonets used for spatial precision Squeezing of vessels <1mm not Surface treatment needed Small blood vessel sealed in coapted tissue Coaption Lines of current flow Figure 3.2. Close-up view of bipolar bayonet forceps on tissue 18 MDT Confidential

19 Collagen 19 MDT Confidential

20 Collagen A Building Block Protein in connective tissue, most abundant protein in body Types I, II and III shrink when exposed to heat Type I skin, tendon, vascular, organs, bone Type II cartilage Type III vascular, skin, intestine, uterus 20 MDT Confidential

21 Collagen + Heat Collagen is a triple helix of 3 polypeptides Helix is held together with x-links Heat causes x-links to break Helix relaxes becoming shorter and fatter 21 MDT Confidential

22 Results of Collagen + Heat Undergo rapid denaturation in heat ranges of degrees Celsius The volume remains the same o The collagen compensates by getting shorter and thicker Idealized Shrinking of a Single Collagen Bundle Initial length and diameter Wall Lumen After 30 % shrink - 20 % larger diameter no shrinkage 15 % shrinkage 25 % shrinkage 26 % shrinkage After 60 % shrink - 58 % larger diameter Figure 4.5. Progressive shrinkage of the circumference of an artery with 1 mm ID,.25 mm wall 22 MDT Confidential

23 Transcollation Technology 23 MDT Confidential

24 24 MDT Confidential

25 How it works Step 1 RF energy & saline is applied to tissue Step 2 Heat induced shrinkage occurs Step 3 Vessels < 1mm may be occluded, reducing bleeding 25 MDT Confidential

26 ROLES of Saline Saline serves three (3) functions / roles: Coupling conducts electrical energy from metal electrode to tissue, even when the electrode is moving Cooling prevents over heating of the tissue surface by limiting it to ~100 C Lubricating allows electrodes to move smoothly across targeted tissue without sticking 26 MDT Confidential

27 RESULTS of using saline (saline coupled) 1. No sticking, carbonization, smoke, char, or odor 2. Ability to quickly stop bleeding from large oozing surfaces 3. Ability to quickly spot coagulate spurting vessels 4. Ability to treat tissue deeply if desired 27 MDT Confidential

28 RESULTS of not using saline (dry contact) Small dry tissue contact areas of very high current density Leads to char and shallow coag near contact points Figure 7.1. Dry coupling of RF to tissue 28 MDT Confidential

29 Dry Contact vs. Saline Coupled Dry Contact: >120 C causes sticking, smoke, char and eschar / small contact area, high current density, shallow & hot effect, often poor hemostasis Saline Coupled: C causes hemostasis / enlarges the contact area and allows a painting motion to treat tissue 29 MDT Confidential

30 Transcollation Technology vs. Electrosurgical Pencil Transcollation Technology ~100º C Poaching effect Steam Pliable tissue result Lubricated electrodes Electrosurgical Pencil ~300º C Grilling effect Smoke Charred result Sticking 30 MDT Confidential

31 Alternatives to Saline??? Can saline be replaced by Lactated Ringers Deionized Water Distilled Water There are NO comparable replacements / alternatives to using saline with Transcollation Devices 31 MDT Confidential

32 Transcollation Bipolar Devices AQUAMANTYS System 32 MDT Confidential

33 BOVIE ~490 KHz AQM ~370 KHz House Current (60 Hz) Neuro-Stimulation Ceases (100 KHz) RF (30 KHz 300 GHz) FREQUENCY SPECTRUM 33 MDT Confidential

34 System Characteristics Simultaneous RF Power and saline delivery Power setting from watts Automatic settings for saline flow rate based on proprietary algorithm Convenient priming mode 34 MDT Confidential

35 Aquamantys Cart Features Shelf with capacity to hold one Aquamantys generator IV pole to hang saline from Basket to store sterile hand pieces 35 MDT Confidential

36 Aquamantys Packaging Display box with MFG & expiration information IFU with each disposable Patient (device) ID label Blister pack with Tyvek lid The device has IV set with spike and pump tubing segment Handle with plug end (attached to device) 36 MDT Confidential

37 Step 1 Connect the single-use disposable to the pump generator Step 2 Load the pump tubing segment Step 3 Spike the saline bag Step 4 Prime Step 5 Set RF power Step 6 Set saline flow rate 37 MDT Confidential

38 The AQUAMANTYS System consists of a multi-use pump generator and single-use disposable hand pieces. 38 MDT Confidential

39 Clinical Applications Orthopaedic Reconstruction hip & knee Orthopaedic Trauma Spine Surgical Oncology liver, pancreas, and kidney 39 MDT Confidential

40 Treatment Techniques AQUAMANTYS System 40 MDT Confidential

41 Treatment Techniques Surface Treatment Compression Torturous Path 41 MDT Confidential

42 Surface (Spot) Treatment BEFORE AFTER Spurting blood Surrounding tissue Artery wall Artery shrinks in circumference, wall thickens, closing the lumen Lines of RF current 1 mm ID Treated zone (lightest tan) Spot coagulation of a 1 mm spurting artery Device shown is 6.0, 2.3 or MBS 42 MDT Confidential

43 Compression Device shown is the EVS 43 MDT Confidential

44 Torturous Path Straddle the vessel with 2 electrodes Twist (rotate) the electrode to compress vessel Activate to coagulation 44 MDT Confidential

45 Proper Performance AQUAMANTYS System 45 MDT Confidential

46 Proper Performance Time Optimal treatment time is the minimum amount of time required to achieve hemostasis of the target tissue areas at the surgical site. Optimal treatment time is determined by a combination of generator output power saline flow electrode-to-tissue contact pressure movement speed of the hand piece electrodes across the tissue being treated 46 MDT Confidential

47 Factors Affecting Speed to Desired Depth of Treatment (1-2mm) with TRANSCOLLATION Technology Power Setting Tissue Density Application Time Technique Saline Flow 47 MDT Confidential

48 Proper Performance Temperature To maintain the appropriate temperature of ~100 C, place the tip of a suction device adjacent to the working area to avoid pooling of blood and saline. Blood and saline pooling decreases the effectiveness of the technology. 48 MDT Confidential

49 Proper Performance Pressure Ensure the device tips are in full contact with tissue prior to activating technology Press firmly and use a circular or linear motion, maintaining constant contact with the tissue when treating broad areas Isolated soft tissue or bone bleeders can be spot treated Avoid dabbing to maintain effectiveness of the technology 49 MDT Confidential

50 Transcollation Monopolar Devices 50 MDT Confidential

51 Characteristics Utilizes saline and radiofrequency (RF) energy Requires non-aquamantys generator Hypotube Outer Insulation Saline Flows: 1 - Hypotube 2 - Slots in stem 3 - Slots under insulation 4 - Through slots in the neck 5 - Out of slots and onto electrode Requires spike set with manual flow control; Saline is gravity fed; needs to be placed ~6-7 ft. above generator (approximately 2 meters) 6 - Down electrode Surface tension wicks saline to side of electrode Tissue Figure Side section view of a DS MDT Confidential

52 Monopolar Device Overview Primarily used in surgical oncology and thoracic applications Two families Open (2) Endoscopic (2) Figure Close-up photo of tip of the DS3.5C - cone tip 52 MDT Confidential

53 Salient Monopolar Open Devices DS3.0 dissecting sealer Figure Photo of the DS3.0 and close-up of tip DS3.5-C dissecting sealer* DS: Dissecting sealer C: Cone 53 MDT Confidential Figure Close-up photo of tip of the DS3.5C - cone tip

54 Salient Monopolar Endoscopic Devices EndoFB3.0 floating ball EndoSH2.0 sealing hook* Endo: Endoscopic FB: Floating ball SH: Sealing hook 54 MDT Confidential

55 Treatment Techniques UNACCEPTABLE Too far from tissue Poor electrical coupling GOOD Light contact with tissue UNACCEPTABLE Pressed too hard Flow occluded, clogging & sticking Figure Contact - floating ball GOOD Works well at almost all angles GOOD OK on vertical tissue using sides UNACCEPTABLE Saline will not flow uphill BEST "face-on" to tissue OK A little angle is acceptable UNACCEPTABLE Not enough contact if just on the rim GOOD Works well in a crevice on the side (L), on the bottom (M), or buried completely (R) OK to HOOK UNDER A VESSEL As long as you've got saline flowing Figure Angle - floating ball Figure Angle - dissecting sealer 55 MDT Confidential

56 56 MDT Confidential

57 Patient Return Pad Biggest Risk PAD BURNS Figure Photo of 57 MDT Confidential pad burn

58 THANK YOU 58 MDT Confidential