• Evaluation of a Bifocal Reflector on a Clinical Lithotripter

  • Author(s)
    : Achim M. Loske PhD ; Fernando E. Prieto PhD ;
    Jorge Gutierrez MD ; Horacio Zendejas BVS ; Alberto Saita MD ;
    Esequiel Velez Gomez MD

    Source : Journal of Endourology Volume:

    18 Number: 1 Page: 7 -- 16

    DOI : 10.1089/089277904322836596

    Publisher : Mary Ann Liebert, Inc.

    ABSTRACT
    Journal of EndoUrology Volume 18 Number 1

    Purpose:
    To perform in vitro and in vivo tests using a clinical lithotripter in order to determine whether a bifocal reflector is more efficient and produces the same or less tissue damage than a conventional ellipsoidal reflector for electrohydraulic lithotripters. Materials and Methods: A standard ellipsoidal and a novel bifocal reflector were tested on a Tripter Compact lithotripter (Direx Medical Systems, Petach Tikva, Israel). The bifocal reflector was constructed by joining two sectors of two rotationally symmetrical ellipsoidal reflectors having different distances between their foci. The F1 foci of the sectors coincided, creating a separation between the F2 foci. The fragmentation efficiency of the reflectors was compared using kidney-stone models. Shockwave-induced trauma was evaluated in vivo by treating both kidneys of six healthy dogs. One kidney was exposed to shockwaves generated with the conventional reflector, and the other kidney was treated using the bifocal reflector. Pressure measurements were obtained for both reflectors using needle hydrophones.

    Results: The new design appeared to be more efficient than the conventional reflector in breaking up kidney-stone models. Tissue damage did not increase when using the bifocal reflector.

    Conclusion:
    The use of bifocal, instead of standard ellipsoidal, reflectors should be considered as an alternative to improve extracorporeal shockwave lithotripsy.

     
  • Focal Cross-Section, the truncated focal area and the truncated focal area and the truncated volume :

  • THREE NEW TOOLS TO COMPARE THE EFFECTIVENESS
    OF SHOCK WAVE LITHOTRIPTERS

    Brian Saltzman MD. Beth Israel-Deaconess Medical Center
    Harvard Medical School, Boston, MA.
    and
    Josef Hochman, BSc. EE.
    Direx Systems Corporation, Natick, MA

    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 indicator of the available energy of a lithotripter and, therefore, has served as a first indicator of the efficiency of the system.

    Some confusion existed in the past regarding the numerical value of this Pressure at F2.

    Due to specific conditions of the Shock Waves, the measurements done with the older Piezoelectric Crystal sensors lead to erroneous high values of pressure (above thousand bars).

    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).

    Using PVDF, the pressure values recorded are "smaller" compared to old Piezoelectric Crystal sensors, but obviously this is are more accurate and "real" values.

    Recently, new Electromagnetic lithotripters were introduced some of them with higher Peak Bar Pressure. This fact leads one to believe that they are more efficient than the traditional spark gap systems.

    Looking carefully we can see that this may be misleading.

    A correct analysis requires one to look not only at the Peak Bar pressure but also at the focal area geometric dimensions.

    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.

    The Total Focal Area which is also used sometimes to compare different lithotripters may be misleading too, 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.

    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.

    They will allow a more precise geometrical comparison of the Focal Areas of different lithotripters and hence their effectiveness.

    MATERIALS AND METHODS


    Specifications of 11 currently used lithotripters were used from published references (Ref 1).

    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).

    The shape of this focal volume is approximately an ellipsoid (a "cigar" or "watermelon" shape) (Ref 2).
    This ellipsoid volume is obtained by rotating the focal ellipse around the long axis.

    The geometric specifications of the focal area are the Long Dimension (LD) and Short Dimension (SD) of the ellipse and ellipsoid. The (a) Long radius and (b) Short Radius equal half of the previous values respectively.


    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).
    We can calculate the Cross Section area using the formula of the circle area

    b = Focal Short Radius =SD/2
    SD=Focal Short Dimension (diameter)


    2) Ellipse shape geometric function



    3) Ellipse Focal Area (EFA)

    Using the ellipse Long Radius a , 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, we can calculate the Truncated Ellipse area using the formula


    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 DimensionSD
    (mm)
    Cross Section Area(mm 2)
    1 1 Dornier Doli S 5 20
    2 Siemens Lithostar 5 20
    3 Edap Praktis 5 20
    4 Storz Modulith 6 28
    5 Siemens Modularis 6 28
    6 Dornier Compact Delta 7.7 47
    7 Healthronics Lithotron 8 50
    8 Medispec Econolith 13 133
    9 Direx Tripter Compact 13.5 143
    10 Medstone STS-T 15 177
    11 Dornier HM-3 15 177
     Average Large Focal Areas 157  
     Standard Deviation 23  
     Average Small Focal Areas 30  
     Standard Deviation 13  
    Small Focal Areas
    Large Focal Areas
    Table and Graph # 1

    2) The Truncated Ellipse Focal Area

    The Graph below represents all focal ellipses and their truncation.

    Truncation of Focal Ellipses
    Table and Graph # 2


    3) Truncated Ellipse Focal Area



     

    Table and Graph # 3


    4) Truncated Ellipsoid Focal Volume



     

    Table and Graph # 4

    DISCUSSION


    Analyzing the results shown in Tables #1 through #4, we may distinguish two categories of Lithotripters:


    a) Large Focus: 4 lithotripters are in this category:
    Dornier HM-3, Medstone STS-T, Direx Tripter Compact, and Medispec Econolith.


    b) Small Focus: 7 Lithotripters are in this category:
    Storz Modulith, Dornier Doli S, Dornier Compact Delta, Siemens Lithostar, Siemens Modularis (All electromagnetic lithotripters), Edap Praktis, and the Healthronics Lithotron (Spark Gap).

    Cross Section Cross Section Truncated Area Truncated Area Truncated Volume Truncated Volume
    Average Standard Deviation Average Standard Deviation Average Standard Deviation
    a) Large Focus 157 23 (15%) 209 16 (8%) 2306 343 (15%)
    b) Small Focus 30 13 (43%) 89 19 (21%) 435 191 (44%)
    Ratio a/b 5.23   2.35   5.3  
    • The 2 categories of Lithotripters are clearly differentiated, the ration of their Cross Sections, Areas and Volumes are between 2.35 and 5.3.
    • The Large Focus group is more homogeneous (Standard Deviation 8 to 15 %) , whereas the Small Focus is less (Standard Deviation 21% to 44 %). This is due to the fact that the Dornier Delta and Healthronics Lithotron have relatively bigger dimensions than the rest of the group, but still far form the Large Focus group.
    • ALL Large Focus Lithotripters use the Spark Gap technology.

      ALL Electromagnetic units fall into the Small Focus category.
    • Two Spark Gap units are also in the Small Focus category: Edap Praktis and Healthronics Lithotron.


    The Edap Praktis, although basically a Spark Device, uses a variation of what is called the Electroconductive Technology.

    The purpose of this technology is to reduce the pressure fluctuation between shocks. In order to achieve this, the system uses a special electrode in a highly conductive liquid, with a very small gap and as a result, the focal volume is much smaller than conventional Spark Gap devices.

    It can be seen on Graph # 1, 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.

    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.

    Recently, 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 6,7 and 8). A trend that is worrisome.

    It is becoming clear that the electromagnetic devices with very long and thin focal area/volumes are not suited to fragment stones.

    The Truncated Areas and Volumes are intended to advance the discussion relative to the effectiveness of various lithotripters.

    REFERENCES

    1. J. Stuart Wolf, Jr. M.D. Issues in choosing a Lithotriptor: Concepts in Design and use. AUA, 2001.

    2. Lewin P.A. and Schafer M.E. "Shock Wave sensors: Requirements and Design. J. Lithotripsy and Stone Disease vol. 3 pp 3-17, 1991.

    3. IEC International Standard pressure Pulse Lithotripters-Characteristics of Fields. 1998 -04 Annex C, page 21.

    4. FDA Guidance for the Content of Premarket Notifications (510 k) for Extracorporeal Shock Wave Lithotripters Indicated for the Fragmentation of Kidney and Ureteral Calculi. August 9, 2000. Page 6.

    5. 1st International Consultation on Stone Disease Committee 8: Bioeffects and Physical Mechanisms of SW Effects in SWL. Chairman: James E. Lingeman, M.D. et al.

    6. Kohrmann KU, Rassweiler JJ, Manning M, et al. The clinical introduction of a third generation lithotriptor Modulith SL 20. Journal of Urology, 1995; 153:1379-1383.

    7. Stefan T, Thorsten B, Chaussy C. Reduced retreatment rate by anatomy related shockwave (SW) energy. Journal of Urology, 1998; 159:S34 (abstract).

    8. Piper NY, Dalrymple N, Bishoff JT. Incidence of renal hematoma formation after ESWL using the new Dornier Doli-S lithotriptor. Journal of Urology, 2001; 165:S377 (abstract).

     
  • 510(k)s Final Decisions Rendered for January 2003

  • SUBMITTER ADDRESS LISTING FOR
    CDRH SUBSTANTIALLY EQUIVALENT (SE)

    510(K) SUMMARIES OR 510(K) STATEMENTS FOR
    FINAL DECISIONS RENDERED DURING THE PERIOD
    01-JAN-2003 THROUGH 31-JAN-2003



    DEVICE: ACCULEAF
    DIREX SYSTEMS CORP.
    510(k) NO:K021338(TRADITIONAL)
    ATTN: LARISA GERSHTEIN
    PHONE NO : 888-874-7837
    11 MERCER ROAD
    SE DECISION MADE 07-JAN-03
    NATICK, MA 01760
    510(k) SUMMARY AVAILABLE FROM FDA

  • Excerpts from the 1st Stone Consultation meeting Paris, July 4-5, 2001

  • 1st International Consultation on Stone Disease

    Committee 8: Bioeffects and Physical Mechanisms of SW Effects in SWL

    Chairman :   
    James E. Lingeman, M.D.
    Committee Members :   
    Michael Delius, M.D.
      
    Andrew Evan, PhD
      
    Mantu Gupta, M.D.
      
    Kemal Sarica, M.D.
      
    Walter Strohmaier, M.D.
    Contributing Authors :   
    James McAteer, PhD
      
    James Williams, PhD


    1) Introduction A

    ….." Unfortunately current lithotriptor designs have not been based on fundamental advances in the basic science of SWL vis-?-vis stone comminution and tissue effects. The result has been that newer generation machines have not improved outcomes for patients and indeed may be both less effective in breaking stones and more traumatic to renal tissue. "

    2) Page 9

    …." In addition, the newer generation lithotriptors that have very small focal areas and extremely high peak positive pressures are reporting higher clinically significant hematoma rates of 3 to 12% (Kohrmann et al, 1995; Stefan et al, 1998; Piper et al, 2001; Ueda et al, 1993), a trend that is worrisome."

    3) Page 10

    …." In addition, Roessler et al (1996) determined the size of lesion induced by an electromagnetic vs. electrohydraulic lithotriptor and found a much larger lesion with the electrohydraulic machines. However, the electromagnetic lithotriptor produced complete cellular destruction at F2, which may explain a higher rate of subcapsular hemorrhage for electromagnetic lithotriptors."


    4) Page 69

    …." Newer generation machines have not improved outcomes for patients. The introduction of new lithotriptors that generate extremely high pressures and tight focal zones does not appear to be much of an improvement, as the need for re-treatment and the incidence of adverse effects with these devices appears to be higher with older machines."


     
  • ESWL Kidney - Urethral Treatment on OBESE Patients

  • 100 treated cases with NOVA ULTIMA Extra Corporal Lithotripter
    (Direx Medical Systems)

    Dr. Ruben Munoz, Dr. Pierre P. Tirolien
    Clinique Saint-Pierre, Guadeloupe, France



    Introduction:
    obesity is considered as an important risk factor for illnesses such as the arterial hypertension, diabetes, coronary and metabolic disorders, etc., increasing considerably the surgical risk. By means of ESWL we treated an interesting number of patients with the purpose to avoid the prolonged and after surgery complications, due patients volume.
    The patients had been selected by use of the Index of Mass Corporal (IMC) of Quetelet:

    25 < IMC < 27 27 < IMC < 30 IMC > 30
      medium overweight important overweight obese


    Material and methods: From April 2000 to August 2001 we have treated 100 obese patients with kidney and urethral stones, using a Nova Ultima Extra Corporal Lithotripter from Direx Medical Systems.
    A neuroleptanalgesic had been done to a 92% of the patients and narconeuroleptanalgesic to an 8% of them. The 85% stayed 24 hours in the hospital and the 15% were ambulatories. Treated patients: 63 men with more than 90 kg weight (90-141) and 37 women with more than 80 kg weight (80-118). Age average: 42 years old (20-72). Treatment on: 77 kidney stones, 12 pelvic stones, and 7 urethral stones. An 80% had been localized by means of an ultrasound scan (more than 50% in lateral posture) and 20% by means of a fluoroscopic. The stone size average was 12 mm. In a 62% of cases the localization was easy and in a 38% it was difficult, principally the urethral and pelvic stones. All the patients received 3000 shoots at KV 21-22, in a high energy with a time average of 35 minutes every session.

    Lateral posture
    Ultrasound scanner
    Localization
    Dorsal posture
    Fluoroscopy
    Localization
    Lateral posture
    Ultrasound scanner
    Localization
    Dorsal posture
    Fluoroscopy
    Localization
    Lateral posture
    Ultrasound scan
    Localization

    The lateral posture permits an excellent ultrasound scans image avoiding abdominal and suprarenal folds and also an improvement to the skin contact with the membrane.

    Results: The results in a three months period had been:

    The best results obtained were with the pelvic and lumbar urethral stones (82%)


    We carried out a supplementary session on 24 patients, two sessions on 6 patients and three sessions on 4 patients (voluminous stones)

    Lower calix (before & after lithotripsy)
     
    Lumbar urethral                 UIV               After lithotripsy
     
    Lower calix (before & after lithotripsy)


    Discussion: For the kidney and urethral stones treatment on obese patients the lithotripter features are very important and the operator experience too. The knowledge and application of the localization systems permits to the specialist to obtain a better percentage of stone free. These techniques are important for these patients due to the posture on the table, which is fundamental to obtain a good result (50% in lateral posture with ultrasound scan).

    Conclusion: The indication of using ESWL on obese patients is a good choice but we always have to be respectful with the criteria of selection. The percentage of stone free in a three-month period has been satisfactory and the complications are similar to the ones published by other authors.

     

    XIV National Conference of Lithiasis and Urinary Endoscopy,
    January 28-29-30, 2002, Sig?enza (Guadalajara, SPAIN)

     

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