This action might not be possible to undo. Are you sure you want to continue?
Direx - Three New Tools to Compare t…
Lithotripsy Duet Magna Duet Compact XL Integra
Home / Products / Lithotripsy / Compact XL / Clinical Data /
Three New Tools to Compare the Effectiveness of Shock Wave Lithotripters
Additional News: ESWL Kidney - Urethral Treatment on Obese Patients The Unique Voluminous
Thermal Therapy Brian Saltzman MD. Beth Israel-Deaconess Medical Center Harvard Medical School, Boston, MA. and Josef Hochman, BSc. EE.Direx Systems Corporation, Natick, MA American Urology Associaton Congress Radiotherapy Focal Cross-Section, the Truncated Focal Area and the Truncated Volume: Orthopaedics Abstract The Peak Pressure at F2 and the Focal Area are the traditional parameters used to compare the performance and effectiveness of the Shock Wave produced by different lithotripters. Lately, new electromagnetic lithotripters were introduced, some with higher Focal Peak Pressure. This fact may lead to believe that they are more efficient than the traditional spark gap systems. At the same time all electromagnetic systems have very thin focal areas, much smaller than the typical stone size, and therefore the available energy is not optimized for stone fragmentation, usually requiring much more shocks compared to a traditional Electrohydraulic lithotripter. The Focal Cross Section at F2, the Truncated Focal Area and Volume are 3 new tools which allow a more accurate evaluation of the Shock Wave characteristics and efficiency of different lithotripters. Eleven currently used lithotripters including the Dornier HM-3 were compared: The results show two categories of Lithotripters: a) Large Focus: Dornier HM-3, Medstone STS-T, Direx Tripter Compact and Medispec Econolith. b) Small Focus: All electromagnetic lithotripters, plus Edap Praktis and the Healthronics Lithotron. The Average Focal Cross Section for Large Focus lithotripters is 5 times bigger than the small ones. The Average Truncated Area is 2.35 times bigger and the Average Truncated Volume is 5 times bigger in Big Focus Lithotripters compared to Small Focus ones. This may help to explain why usually the electromagnetic lithotripters require much more shocks to break stones and have larger retreatment rates. Introduction Various lithotripters using different Shock Wave technologies are currently offered to treat stones in the urinary tract. In order to compare the various systems offered, Urologists analyze their technical specifications to evaluate their performance. (Ref 1) Traditionally the Peak Bar Pressure at F2 is the first parameter considered as an
and Staghorn Stones Treated With the Nova Ultima (Direx).80 Cases Evaluation of a Bifocal Reflector on a Clinical Lithotripter
We can calculate the Cross Section area using the formula of the circle area b = Focal Short Radius =SD/2 direxgroup. This fact leads one to believe that they are more efficient than the traditional spark gap systems. Due to specific conditions of the Shock Waves. The geometric specifications of the focal area are the Long Dimension (LD) and Short Dimension (SD) of the ellipse and ellipsoid. Looking carefully we can see that this may be misleading. because it does not take into account the fact that the typical stone size is much smaller than the long axis of the Focal ellipse and therefore a big portion of the energy is not applied to the stone.Three New Tools to Compare t… indicator of the available energy of a lithotripter and. has served as a first indicator of the efficiency of the system. the measurements done with the older Piezoelectric Crystal sensors lead to erroneous high values of pressure (above thousand bars). Using PVDF. During the last years a new precise sensor made of a membrane of Poly Vinyl Duo Fluoride (PVDF) was developed and adopted by FDA as the only one to be used in Pressure measurements (Ref 2). therefore. The (a) Long radius and (b) Short Radius equal half of the previous values respectively. In order to clarify this issue three new tools were developed and are presented: a) The Focal Cross Section b) The Truncated Ellipse Focal Area c) The Truncated Focal Volume.com/three-new-tools-to-co… 2/7 . new Electromagnetic lithotripters were introduced some of them with higher Peak Bar Pressure. The distribution of pressure of a lithotripter is centered at the focal point F2 and includes all points whose pressure is between 100% ( f2) and 50% of the Peak Power( 6 dB). Some confusion existed in the past regarding the numerical value of this Pressure at F2.5/12/2010 Direx . The shape of this focal volume is approximately an ellipsoid (a "cigar" or "watermelon" shape) (Ref 2). therefore the available energy is not optimized for stone fragmentation. They will allow a more precise geometrical comparison of the Focal Areas of different lithotripters and hence their effectiveness. Recently. A correct analysis requires one to look not only at the Peak Bar pressure but also at the focal area geometric dimensions. This ellipsoid volume is obtained by rotating the focal ellipse around the long axis. Materials and Methods Specifications of 11 currently used lithotripters were used from published references (Ref 1). The Total Focal Area which is also used sometimes to compare different lithotripters may be misleading too. the pressure values recorded are "smaller" compared to old Piezoelectric Crystal sensors.much smaller than the typical stone size-and. 1) Focal Area Cross Section (FACS) The easiest way of visualizing how much of the stone is subjected to pressure is to look at the Cross Section of the ellipsoid at F2 (Like "cutting" the ellipsoid/cigar at F2 and looking at the circle that originated). but obviously this is are more accurate and "real" values. All Electromagnetic systems have very thin focal areas .
Three New Tools to Compare t… SD=Focal Short Dimension (diameter) 2) Ellipse shape geometric function 3) Ellipse Focal Area (EFA) Using the ellipse Long Radius a . we can calculate the Truncated Ellipse area using the formula5) Ellipsoid Focal Volume (EFV) 5) Ellipsoid Focal Volume (EFV) 6) Truncated Ellipsoid Focal Volume (TEFV) Results Calculations and graphs were made using the Excel (Microsoft) Program 1) 1) Focal Area Cross Section Focal Cross Sections at F2 Circle # Manufacturer Model Diameter Short Dimension SD(mm) Cross Section Area (mm 2) 20 1 1 Dornier Doli S 5 direxgroup.5/12/2010 Direx .com/three-new-tools-to-co… 3/7 . and the Short Radius b. we can calculate the full Ellipse area using the formula 4) Truncated Ellipse Focal Area (TEFA) Using the Long Radius a. and the Short Radius b.
5 15 15 20 20 28 28 47 50 133 143 177 177 Average Large Focal Areas Standard Deviation Average Small Focal Areas Standard Deviation 157 23 30 13 Small Focal Areas Table and Graph # 1 2) The Truncated Ellipse Focal Area Large Focal Areas The Graph below represents all focal ellipses and their truncation.Three New Tools to Compare t… 2 3 4 5 6 7 8 9 10 11 Siemens Edap Storz Siemens Dornier Healthronics Medispec Direx Medstone Dornier Lithostar Praktis Modulith Modularis Compact Delta Lithotron Econolith Tripter Compact STS-T HM-3 5 5 6 6 7.5/12/2010 Direx .7 8 13 13.com/three-new-tools-to-co… 4/7 . Truncation of Focal Ellipses Table and Graph # 2 3) Truncated Ellipse Focal Area direxgroup.
Dornier Doli S. Dornier Compact Delta. Large Focus: 4 lithotripters are in this category: Dornier HM-3. Siemens Modularis (All electromagnetic lithotripters).5/12/2010 Direx .Three New Tools to Compare t… Table and Graph # 3 4) Truncated Ellipsoid Focal Volume Table and Graph #4 Discussion Analyzing the results shown in Tables #1 through #4. Direx Tripter Compact. Small Focus: 7 Lithotripters are in this category:Storz Modulith. 2. Siemens Lithostar. and Medispec Econolith. Edap Praktis. Medstone STS-T.com/three-new-tools-to-co… 5/7 . we may distinguish two categories of Lithotripters: 1. and the Healthronics Lithotron direxgroup.
whereas the Small Focus is less (Standard Deviation 21% to 44 %). 3 pp 3-17. but still far form the Large Focus group. M. This is due to the fact that the Dornier Delta and Healthronics Lithotron have relatively bigger dimensions than the rest of the group. 5. page 21. Issues in choosing a Lithotriptor: Concepts in Design and use. although basically a Spark Device. Chairman: James E. Lingeman. 1998 -04 Annex C. Jr. the ration of their Cross Sections. 2. It can be seen on Graph # 1.com/three-new-tools-to-co… 6/7 . AUA. Two Spark Gap units are also in the Small Focus category: Edap Praktis and Healthronics Lithotron. 2000. M. The Truncated Areas and Volumes are intended to advance the discussion relative to the effectiveness of various lithotripters. A trend that is worrisome. The Edap Praktis. August 9.3 The 2 categories of Lithotripters are clearly differentiated. and Schafer M. The Large Focus group is more homogeneous (Standard Deviation 8 to 15 %) . with a very small gap and as a result. the focal volume is much smaller than conventional Spark Gap devices.D. Recently. "Shock Wave sensors: Requirements and Design. ALL Electromagnetic units fall into the Small Focus category. This may explain why the electromagnetic devices typically require significantly more shocks to adequately fragment kidney stones and also may result in higher retreatment rates.35 and 5. Lewin P. concerns have been raised ( Ref 5) regarding the fact that some new Electromagnetic Lithotripters that have very small focal areas and extremely high peak positive pressures are reporting higher clinically significant hematoma rates of 3 to 12% (Ref 6. The purpose of this technology is to reduce the pressure fluctuation between shocks. ALL Large Focus Lithotripters use the Spark Gap technology. 3. Page 6.E.7 and 8). uses a variation of what is called the Electroconductive Technology.Three New Tools to Compare t… (Spark Gap) Cross Section Cross Section Truncated Truncated Truncated Truncated Area Area Volume Volume Standard Deviation 16 (8%) 2306 Average Standard Deviation 343 (15%) 30 13 (43%) 89 19 (21%) 435 191 (44%) Average Standard Average Deviation a)Large Focus b) Small Focus Ratio a/b 5. References 1. It is becoming clear that the electromagnetic devices with very long and thin focal area/volumes are not suited to fragment stones.A. Stuart Wolf. 1991. et al.3.35 157 23 (15%) 209 5. direxgroup. Areas and Volumes are between 2. FDA Guidance for the Content of Premarket Notifications (510 k) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi. 1st International Consultation on Stone Disease Committee 8: Bioeffects and Physical Mechanisms of SW Effects in SWL. J. 2001.23 2. the system uses a special electrode in a highly conductive liquid. that the Large Focus Lithotripters will " cover" most of the stone areas at F2 ( diameter 13 to 15 mm) whereas the Small Focus ones will cover only a fraction of the typical stone. In order to achieve this. 4. J. Lithotripsy and Stone Disease vol.5/12/2010 Direx . IEC International Standard pressure Pulse Lithotripters-Characteristics of Fields.D.
Manning M. Piper NY. Incidence of renal hematoma formation after ESWL using the new Dornier Doli-S lithotriptor. Thorsten B. 1995. 1998. Dalrymple N. Journal of Urology. Journal of Urology. 8.Three New Tools to Compare t… 6. et al. 153:1379-1383. Chaussy C. 159:S34 (abstract). Bishoff JT. Stefan T. 165:S377 (abstract). Journal of Urology. Reduced retreatment rate by anatomy related shockwave (SW) energy. Kohrmann KU. Rassweiler JJ. direxgroup. The clinical introduction of a third generation lithotriptor Modulith SL 20. 2001. 7.com/three-new-tools-to-co… 7/7 .5/12/2010 Direx .